Nexium form. For adults and children over the age of twelve

Instructions for the use of Nexium in powder, a description of the action of the drug, indications for the use of Nexium powder, interaction with other drugs, the use of Nexium (powder) during pregnancy. Instructions: ;

Tradename:	Nexium
International name:	Esomeprazole
Dosage form:	Lyophilizate for solution for intravenous administration
Indications for use:
ATS classification:	A Drugs affecting the digestive system and metabolism A02 Preparations for the treatment of acid-dependent diseases A02B Peptic ulcer and gastroesophageal reflux disease agents A02B C Proton pump inhibitors
Pharm. Group:	Antiulcer drugs and drugs for the treatment of gastroesophageal reflux (GORD). proton pump inhibitors. Esomeprazole. ATX code A02BC05
Storage conditions:	Store at a temperature not exceeding 25°C, in the original packaging, protected from light. A bottle without a carton can be stored at room light for no more than 24 hours. Keep out of the reach of children!
Shelf life:	2 years. Do not use after the expiration date.
Terms of sale:	On prescription
Description:	Lyophilisate from white to almost white.

Instruction content:

The composition of Nexium in powder

The active substance of Nexium

esomeprazole sodium 42.5 mg equivalent to 40 mg esomeprazole

40 mg esomeprazole balamala 42.5 mg esomeprazole sodium

Excipients in Nexium

ethylenediaminetetraacetic acid disodium salt 1.5 mg, sodium hydroxide 0.2-1.0, nitrogen for injection, water for injection

1.5 mg ethylenediaminetetrasirke kyshkylynyn ekі sodium tyzy, sodium hydrototygy 0.2-1.0, injection arnalgan nitrogen, injection arnalgan su

Indications for the use of Nexium powder

Nexium for intravenous administration is indicated as an alternative to oral therapy when it is impossible to carry it out:

• gastroesophageal reflux disease in patients with esophagitis and/or severe symptoms of reflux disease

• treatment and prevention of peptic ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs)

• prevention of rebleeding in patients after endoscopic treatment of acute bleeding of a gastric or duodenal ulcer

Koktamyr ishine engizuge arnalgan Nexium ishu arkyly em zhүrgizu mүmkin bolmaғan kezde onyn balamasy retіnde kөrsetilgen:

• esophagitis zhane\nemesse reflux aurudyn aykyn belgilerі bar emdelushіlerdegi gastro-esophageal reflux aura

• kabynuga karsy steroids emes preparationtardy (ҚҚSP) kabyldaumen baylanysty peptikalyқ oyyk zharalardy emdeu zhane aldyn alu

• askazannyn nemese he ekі elі іshektіn oyyk zharasynan zhedel kan ketudі endoscopy emdegennen keyin emdelushіlerde kaita kan ketu damuynyn aldyn alu

Contraindications of Nexium in powder

• known hypersensitivity to esomeprazole, substituted benzimidazoles or other ingredients of the drug

• children and adolescents under 18 years of age (due to lack of data on safety and efficacy)

• co-administration with nelfinavir

• lactation period

• esomeprazole, almastyrylgan benzimidazole nemese drug baska ingredient terine belgili jogary sezimtaldyk

• 18 zhaska deyingі balalar men zhasөspіrіmderge

• nelfinavirmen birge koldanu

• lactation

Side effects of Nexium powder

Often(>1/100, <1/10)

• headache

• nausea, abdominal pain, diarrhoea, flatulence, vomiting, constipation

Less often(>1/1000, <1/100)

• dermatitis, pruritus, urticaria, rash

• dizziness

• dry mouth

• insomnia, paresthesia, drowsiness

• increased activity of "liver" enzymes

• peripheral edema

• blurred vision

Rarely(>1/10000, <1/1000)

• leukopenia, thrombocytopenia

• allergic reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock

• agitation, depression, malaise, confusion

• taste disorder

• hyponatremia

• bronchospasm

• stomatitis and gastrointestinal candidiasis

• hepatitis with or without jaundice

• photosensitivity, alopecia

• arthralgia, myalgia

• sweating

Very rarely (<1/10000)

• agranulocytosis, pancytopenia

• hallucinations (mainly in debilitated patients), aggressive behavior

• liver failure, encephalopathy in patients with liver disease

• erythema multiforme exudative

• Stevens-Johnson syndrome

• toxic epidermal necrolysis

• muscle weakness

• interstitial nephritis

• gynecomastia

• hypomagnesemia, severe hypomagnesemia can lead to hypocalcemia

• microscopic colitis

Individual cases of irreversible visual impairment have been reported with intravenous administration of omeprazole to critically ill patients, especially with the introduction of high doses, a causal relationship with the drug has not been established.

Zhii(1/100, 1/10)

• bass auyru

• Zhurek Ainu, ishtin auyruy, diarrhea, flatulence, kusu, ish katu

Zhііlіgі az(1/1000, 1/100)

• dermatitis, kyshynu, esekzhem, börtpe

• bass ainalu

• auyz ishinin kebersui

• uykysyzdyk, paresthesia, uykyshyldyk

• "Bauyr" fermenter and belsendilіgіnіn zhogarylauy

• shetkergi isinuler

• anyқ kormeu

Sirek (1/10000, 1/1000)

• leukopenia, thrombocytopenia

• allergic reaction: kyzba, angioedema, anaphylactic reaction / anaphylactic shock

• kozu, depression, dimkastanu, abyrzhu

• däm sezinudin nasharlauy

• hyponatremia

• bronchus tuyilui

• stomatitis zhane askazan-ishektik candidiasis

• sargayumen (nemese onsyz) hepatitis

• photosensitivity, alopecia

• arthralgialar, myalgialar

• tershendik

Ote Sirek(1/10000)

• agranulocytosis, pancytopenia

• elesteuler (negіzіnen аlsіz emdelushіlerde), ozbyr minez-құlyқ

• bauyr zhetkіlіksіzdіgі, bauyr aurulary bar emdelushіlerdegi encephalopathy

• multiformals exudates erythema

• Stevens-Johnson syndromes

• epidermal necrolysis

• bұlshyқet әlsіzdіgі

• interstitial nephritis

• gynecomastia

• hypomagnesemia, auyr hypomagnesemia hypocalcemia, alyp kelui mumkin

• microscopial colitis

Katerli akhualdagy emdelushilerge omeprazoledy koktamyr ishine engizgende, asirese zhogary dozalaryn engizgende kөrudin kaitymsyz nasharlauynyn zhekelegen zhagdaylary zhoninde khabarlangykany

Special instructions for use

If any worrisome symptoms are present (eg, such as significant spontaneous weight loss, recurrent vomiting, dysphagia, hematemesis, or melena), or if a stomach ulcer is present (or if a stomach ulcer is suspected), malignancy should be ruled out because treatment with Nexium can lead to a smoothing of symptoms and delay the diagnosis.

Carefully: patients with severe renal insufficiency. Treatment with proton pump inhibitors may lead to a slight increase in the risk of gastrointestinal infections caused by Salmonella and Campylobacter. In patients taking antisecretory drugs for a long period of time, the formation of glandular cysts in the stomach is more common. These phenomena are due to physiological changes as a result of pronounced inhibition of acid secretion. The cysts are benign and reversible.

Pregnancy and lactation

There are currently limited data on the use of esomeprazole during pregnancy. The drug should be prescribed during pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Given the side effects of the drug, care should be taken when driving a vehicle or potentially dangerous mechanisms.

Кез келген үрейлену белгілері орын алғанда (мысалы, дене салмағын күрт едәуір жоғалту, қайта-қайта құсу, дисфагия, қан аралас құсу немесе мелена), сондай-ақ асқазанның ойық жарасы болғанда (немесе асқазан ойық жарасынан күдіктенгенде) қатерлі жаңа түзілімнің бар-жоғын анықтаған dұrys, өytkenі Nexiummen emdeu belgilerdіn tegisteluіne аkelip, diagnosis қoyyluyn kesheuіldetuі mүmkin.

Saқtyқpen: auyr bүyrek zhetkіlіksіzdіgі bar emdelushіlerge.

Protondyk pump tezhegishterimen emdeu Salmonella men Campylobacter tugyzatyn askazan-ishek zhұkpalarynyn payda bolu kaupinin bolymsyz artuyna alyp keledi. Sөl bөluge karsy preparattardy ұzaқ uaқyt aralygy kezіnde қabyldaytyn emdelushіlerdіn asқazanynda bezdіk kistalardyң tүzіluі zhiі bolady. Bul құbylystar қyshқyl sөlіnіsіn ayқyn tezheu nәtizhesinde bolatyn physiologylyқ өzgerіstermen sharttalғan. Kistalar katersiz zhane kaytymdy sipatta bolada.

Zhuktilik zhane lactation kezen

Kazirgі uakytta esomeprazole zhүktіlіk kezenіnde koldanu zhonіndegi derekter shekteuli. Preparations zhүktіlіk kezenіnde ana үshіn kutіletіn paidasy ұryққа tonetіn bolzhamdy қauipten basym bolғan zhағdayda ғana tagayyndau kerek.

Dаrіlіk zattyn kөlіk құralyn nemese қauіptіlіgі zor mechanism derdi baskaru kabіletіne аser etu erekshelіkterі

Darilik zattyn zhagymsyz әserlerin eskere otyryp, kөlik құralyn nemese қauіptіlіgі zor mechanism derdi baskargan kezde saktyқ sharasyn қadaғalau kerek.

Dosage and method of application

adults

If oral therapy is not possible, patients may be recommended Nexium parenterally at a dose of 20-40 mg 1 time per day.

For the treatment and prevention of peptic ulcers associated with the use of NSAIDs, Nexium is recommended at a dose of 20 mg 1 time per day.

As a rule, the period of treatment with the intravenous form is short, the patient should be transferred to oral administration of the drug as soon as possible.

Injections

Dose 40 mg

The prepared Nexium solution is administered intravenously for at least 3 minutes.

Dose 20 mg

1/2 of the prepared solution of esomeprazole is administered intravenously for at least 3 minutes. Unused solution residues must be destroyed.

Infusions

Dose 40 mg

The prepared solution of esomeprazole is administered as an intravenous infusion over 10 to 30 minutes.

Dose 20 mg

1/2 of the prepared solution of esomeprazole is administered as an intravenous infusion over 10 to 30 minutes. Unused solution residues must be destroyed.

Prevention of rebleeding in patients after endoscopic treatment of acute bleeding of a gastric or duodenal ulcer

After endoscopic treatment of acute bleeding of a gastric or duodenal ulcer, the dose of the drug is 80 mg, which is administered as a bolus infusion for 30 minutes, followed by a long-term intravenous infusion at a dose of 8 mg / h for 3 days (72 hours).

Bolus dosage equal to 80 mg.

The prepared solution of esomeprazole is administered as a continuous intravenous infusion over 30 minutes.

Dosage 8 mg/h

The prepared solution of esomeprazole is administered as a long-term intravenous infusion for 71.5 hours (estimated infusion rate is 8 mg/h).

Bleeding ulcer

Dose adjustment of Nexium in patients with mild to moderate hepatic impairment is not required. In patients with severe hepatic impairment, after an initial dose of 80 mg administered as a bolus infusion, a continuous intravenous infusion of 4 mg/h for 71.5 hours should be limited.

Impaired kidney function

Dose adjustment of Nexium in patients with impaired renal function is not required. Due to limited experience with Nexium in patients with severe renal insufficiency, caution should be exercised when treating such patients.

Impaired liver function

Dose adjustment of Nexium in patients with mild to moderate hepatic impairment is not required. In patients with severe hepatic impairment, the maximum daily dose is 20 mg.

Elderly patients

Dose adjustment of Nexium in elderly patients is not required.

Solution preparation

Injections

The solution for injection is prepared by adding 5 ml of a 0.9% sodium chloride solution for intravenous administration to a vial with Nexium. The prepared solution should be transparent, the color range varies from colorless to pale yellow.

When prescribing 20 mg of esomeprazole, half of the prepared solution is injected. Unused solution residues must be destroyed.

Infusions

The infusion solution is prepared by dissolving the contents of one Nexium vial in 100 ml of a 0.9% sodium chloride solution for intravenous administration.

When prescribing 20 mg of esomeprazole, half of the prepared solution is injected.

Infusions of 80 mg. The infusion solution is prepared by dissolving the contents of two bottles of Nexium 40 mg in 100 ml of 0.9% sodium chloride solution for intravenous administration. Unused solution residues must be destroyed.

The diluted solution of esomeprazole is a clear, colorless to pale yellow liquid.

The prepared solution (for injections and for infusions) should not be mixed or administered together with other drugs. Before use, the solution should be evaluated visually for the absence of visible mechanical impurities and discoloration. Only a clear solution may be used. The prepared solution is recommended to be administered immediately after preparation (from a microbiological point of view). The prepared solution should be used within 12 hours. Store at a temperature not exceeding 30°C.

Eresekter

Іshu arkyly I eat zhүrgіzu mүmkin bolmaғan emdelushіlerge taulіgіne 1 ret 20 - 40 mg parenteral dose Nexium ұsynuғa bolada.

Reflux esophagitis bar emdelushilerge esomeprazole 40 mg dose of tauligine 1 pt. GERA belgilerin emdeu ushin Nexium taligine 1 ret 20 mg dose of coldanylada.

ҚҚSP kabyldaumen baylanysty peptikalyқ oyyқ zhalalardy emdeu zhane aldyn alu үshіn tаuligіne 1 ret 20 mg doses of Nexium ұsynylady.

Adette, kөktamyrіshіlіk tүrmen emdeu kezenі ұzaққa sozylmaidy, emdelushіnі preparations іshu arқyly қabyldauғa mүmkіndіgіnshe zhyldam kөshіru kerek.

Injectionlar

40 mg dose

Nexiumnіn azirlengen erіtіndіsi kөktamyr іshіne keminde 3 minutes іshіnde engіzіlеdi.

20 mg dose

Esomeprazoledyn 1/2 әzіrlengen erіtіndіsi kоktamyr іshіne keminde 3 min іshіnde engіzіlеdi. Yeritindininin paidalanylmagan kaldyktary zhoyyluy tiis.

Infusionalar

40 mg dose

Esomeprazoledyn azirlengen eritindіsi köktamyrіshіlіk infusion tүrіnde 10-30 minutes ishіnde engіzіlіdі.

20 mg dose

Esomeprazoledyn 1/2 azirlengen eritindisi koktamyrishilik infusion turinde 10-30 minutes ishinde engiziledi. Yeritindininin paidalanylmagan kaldyktary zhoyyluy tiis.

Askazannyn nemese he ekі elі іshektіn oyyk zharasynan zhedel kan ketudі endoscopy emdeuden keyin emdelushіlerde kaitadan kan ketu damuynyn aldyn alu

Асқазанның немесе он екі елі ішектің ойық жарасынан жедел қан кетуді эндоскопиялы емдегеннен кейін препарат дозасы 80 мг құрайды, ол 30 минут ішінде болюсті инфузия түрінде енгізіледі, одан кейін сағатына 8 мг дозада 3 күн бойы (72 сағат) ұзақ көктамырішілік инфузия жүргізіледі.

80 mg ten bolus dozalau

Azirlengen esomeprazole erіtіndіsi ұzak koktamyrіshіlіk infusion tүrіnde 30 minutes fights engіzіlіdі.

8 mg/sag. doses

Azirlengen esomeprazole eritindіsi 71.5 sagat ishinde ұzak koktamyrіshіlіk infusion turinde engіzіlіdі (infuziyanyn eseptі zhyldamdyғy - 8 mg/sag.).

Oyyk zharadan kan ketu

Auyrlygy zhenіl zhane ortasha dаrezhedegі bauyr funktsiyasynyn bұzyluy bar emdelushіlerde Nexium dozasyn retteu kazhet emes. Bauyr functions auyr buzylgan emdelushilerde bolusty infusion turinde engizilgen bastapky 80 mg dozalaudan keyin 71.5 sagat ishinde sagatyna 4 mg

Balalar

Koldanyluy zhonindegi derekterdin bolmauyna orai, balalarda Nexium koldanu usynylmayda.

Buyrek function son buzyluy

Buyrek funktsiyasy bұzylgan emdelushіlerde Nexium dozasyn retteu kazhet emes. Buyrek zhetkіlіksіzdіgі auyr emdelushіlerde Nexium koldanu tаzhіribesіnіn shekteuli ekenіne orai, osynday emdelushіlerdi emdegende saktyk sharasyn kadaғalau kerek.

Bauyr function son buzyluy

Auyrlygy zhenіl zhane ortasha dаrezhedegі bauyr funktsiyasynyn bұzyluy bar emdelushіlerde Nexium dozasyn retteu kazhet emes. Bauyr funktsiyasy auyr buzylgan emdelushilerde en zhogary tauliktik dose of 20 mg kuraida.

Where zhastagy emdelushiler

Where zhastagy emdelushilerde Nexium dozasyn retteu seems emes.

Eritindi dayyndau

Injectionlar

Injection arnalgan eritindі Nexium bar kutyga koktamyr ishine engizuge arnalgan 5 ml 0.9% sodium chlorideinin eritindіsin kosu arkyly dayyndalada.

Azіrlengen erіtіndі mоldir boluy tiіs, tusti gammasy tүssіzden bozғylt-sary tusk deiіn құbylady.

20 mg esomeprazole tagayyndalgananda azirlengen eritindininin zhartysy engiziledi. Yeritindininin paidalanylmagan kaldyktary zhoyyluy tiis.

Infusionalar

Infuziyalyk eritindі Nexium bar bіr құtynyn іshіndegіsіn koktamyr іshіne engizuge arnalғan 100 ml 0.9% sodium chlorideinіn erіtіndisinde erіtu argyly azirlenedі.

20 mg esomeprazole tagayyndalgananda azirlengen eritindininin zhartysy engiziledi.

80 mg infusion. Infuziyalyk eritindі 40 mg Nexium bar ekі құtynyn іshіndegіsіn koktamyr іshіne engіzuge arnalғan 100 ml 0.9% sodium chlorideinіn erіtіndіsіnde erіtu argyly аzіrlenedі. Yeritindininin paidalanylmagan kaldyktary zhoyyluy tiis.

Syyltylgan esomeprazole erіtіndіsі tүssіzden bozғylt-sary tүske deyіngі mөldіr suyyқtyқ turіnde bolada.

Dayyndalgan erіtіndіnі (injection үshіn zhane infusion үshіn) baska darіlіk zattarmen birge aralastyruғa nemese engizuge bolmaydy. Қoldanar aldynda erіtіndіde kөrіnetіn mekhanikalyқ қospalardyң bolmauyn zhane tүsіnің өzgerіsіn kozben karap bagalau kerek. Tek möldir erіtіndіnі paydalanuga bolada. Dayyndalgan erіtіndіnі azirlegennen keiіn birden (microbiologylyқ kөzқaras turgysynan) engіzu ұsynylady. Dayyndalgan erіtіndіnі 12 sаgat ishіnde paydalangan zhon. 30С-den aspaytyn temperature and saktau kerek.

Drug Interactions

Effect of esomeprazole on the pharmacokinetics of other drugs

Suppression of gastric acidity during treatment with esomeprazole and other PPIs can lead to a change in the absorption of drugs, the absorption of which depends on the acidity of the environment. Esomeprazole, like other drugs that reduce gastric acid secretion, can lead to a decrease in the absorption of ketoconazole, itraconazole and erlotinib. At the same time, when co-administering esomeprazole with digoxin, the concentration of the latter may increase. With the joint use of PPIs and methotrexate, there is an increase in concentration in some patients. When using methotrexate in high doses, it is necessary to stop taking esomeprazole.

In cases where atazanavir and nelfinavir were taken concomitantly with omeprazole, a decrease in serum levels of these drugs was noted, so their combined use should be avoided. Co-administration of omeprazole 40 mg once daily with atazanavir 300 mg/ritonavir 100 mg resulted in a significant decrease in AUC values, as well as maximum and minimum concentrations of atazanavir. Increasing the dose of atazanavir to 400 mg did not compensate for the effect of omeprazole on atazanavir concentrations. Therefore, esomeprazole should not be co-administered with atazanavir, and co-administration of esomeprazole and nelfinavir is excluded.

Nexium inhibits CYP2C19, the main enzyme involved in its metabolism. Co-administration of esomeprazole with other drugs metabolized by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin, etc., may lead to an increase in plasma concentrations of these drugs and require a dose reduction. With oral co-administration of 30 mg of Nexium and diazepam, the clearance of diazepam, which is a substrate of CYP2C19, is reduced by 45%.

When Nexium was taken orally at a dose of 40 mg and phenytoin in patients with epilepsy, the residual plasma concentration of phenytoin increased by 13%. In this regard, it is recommended to control the concentration of phenytoin in plasma at the beginning of treatment with esomeprazole and when it is canceled.

When prescribing Nexium orally at a dose of 40 mg to patients receiving warfarin, the coagulation time remained within acceptable limits. However, several cases of a clinically significant increase in the INR index (international normalized ratio) have been reported with the combined use of warfarin and esomeprazole. In this regard, monitoring is recommended at the beginning and at the end of the combined use of these drugs.

Co-administration of Nexium at a dose of 40 mg and cisapride increased the area under the concentration-time curve (AUC) by 32% and increased the half-life (t1 / 2) for cisapride by 31%; peak plasma concentrations of cisapride did not change significantly. A slight prolongation of the QT interval, which was observed with cisapride monotherapy, did not increase with the addition of esomeprazole.

It has been shown that Nexium does not cause clinically significant changes in the pharmacokinetics of amoxicillin and quinidine.

Co-administration with esomeprazole resulted in an increase in serum tacrolimus concentrations.

In vivo studies of drug interactions of esomeprazole with the introduction of large doses intravenously (80 mg + 8 mg / h) have not been conducted. The effect of esomeprazole on drugs metabolized by CYP2C19 may be more pronounced with intravenous administration of the drug, so patients should be carefully monitored for 3 days after intravenous administration in order to detect side effects in a timely manner.

The effect of drugs on the pharmacokinetics of Nexium.

Nexium metabolism involves CYP2C19 and CYP3A4. Co-administration of Nexium and the CYP3A4 inhibitor clarithromycin (500 mg twice daily) resulted in a twofold increase in AUC for esomeprazole. The combined use of esomeprazole and a combined inhibitor of CYP3A4 and CYP2C19, for example, voriconazole, can lead to a more than 2-fold increase in the AUC value for Nexium. In such cases, dose adjustment of Nexium is not required. However, dosage adjustment may be required in patients with severe hepatic impairment when long-term therapy is prescribed.

Esomeprazoledin baska darіlіk drug pharmacokinetics asyna

Esomeprazolemen zhane baska PPT-men emdeu ayasynda askazan sөli қyshқyldylygynyң bәsenңdeuі sіңuі қyshқyldy ortaғa tәueldі preparattardyң sіңіrіlu қyshқyldylyғynyң bәsenңуі sіңuі қyshқyldy ortaға tәueldі drugtardyң sіңіrіlu қyshқyldylyғynyң bәsenңуі sіңuі қyshқyldy ortaға tәueldі drugtardyң sіңіrіlu өzgerіsіne аkeledі. Esomeprazole, asқazandagy қyshқyl сөlіnіsіn tөmendetetіn baskа preparattar siyaқty, ketoconazole, itraconazole zhane erlotinib sіңіrіluіnіn tөmendeuіne alyp keledі.

Sonymen katar, esomeprazole digoxinmen birge kabyldanganda songysynyn concentration son arttyr alada. PPT men methotrexate birge kabyldangan kezde keibir emdelushilerde concentration koterilu bolady. Zhogary dozalarda methotrexate koldananda esomeprazole kabyldaudy toқtata turu kazhet.

Atazanavir men nelfinavir omeprazolemen bir mezgilde kabyldangan zhagdaylarda sarysuda wasp preparattar deңgeyinіn tömendeui boldy, sondyқtan olardy үylestirіp қoldanudan aulak bolu kerek. Taulіgіne bir ret 40 mg dosadagy omeprazole men 300 mg atazanavir/100 mg ritonavirdi birge taғayyndau AUC manderinіn, sonday-ақ atazanavirdіn en jogary zhane en tömen concentration Atazanavir dozasyn 400 mg dein arttyru omeprazoledin atazanavir Sondyktan esomeprazoledy atazanavirmen birge taғayyndauғa bolmaida, al esomeprazole men nelfinavirdi bir mezgіlde tagayyndauғa mulde zhol berilmeydi.

Nexium ozinin metabolismine katysatyn negizgi CYP2C19 enzyme tezheid. Esomeprazole metabolism, CYP2C19, tysatyn diazepam, citalopram, imipramine, clomipramine, phenytoin, etc. siyakty baska drugtarmen birge koldanu plasmada osa drug concentrationlarynyn zhogarylauyna akelіp, dosed azaitudy talap etedi. 30 mg Nexium men diazepamdy ishu arkyly birge kabyldagan kezde CYP2C19 substrates large tabylatyn diazepam clearance 45 tomendeid.

Isuge arnalgan 40 mg doses of Nexium men phenytoindi birge kabyldagananda epilepsy and shaldykan emdelushilerde plasmadagy phenytoinnin kaldyk concentrations of 13 zhogarylady. Osygan orai, esomeprazolemen emdey bastaganda zhane ony toktatkanda plasmadagy phenytoin concentrationsyn bakylau usynylady.

Ishuge arnalgan 40 mg dose Nexium warfarin alatyn emdelushilerge tagayyndalganda coagulation uakyty rұқsatty mander shegіnde kaldy. Alaida warfarin men esomeprazoledy birge koldanganda KhҚҚ (khalykaralyk kalyptastyrylgan katynas) indexinin klinikalyk manyzdy artuynynn birneshe zhagdaylary zhoninde habarlandy. Osygan orai, wasps preparattardy birge koldanu bastalganda zhane ayaktalgananda monitoring of zhasau usynylody.

40 mg dose Nexium men cisapridti іshu arkyly bіrge kabyldau "concentration - uaқyt" kisygy astyndagy audan (AUC) shamasyn 32% cisapridtin plasmadagy zhogary shekti concentration of wasps oraida eleuli ozgermegen. Cisapride monotherapy with kezinde baikalgan QT aralygynyn mardymsyz ұzaruy esomeprazole koskan kezde ulғaimagan.

Nexium amoxicillin men quinidine

Esomeprazolemen birge tagaiyndau sarysudagy tacrolimus concentration son zhogarylauyn alyp keldi.

Koktamyr іshіne үlken dozalardy (80 mg + 8 mg/sag.) Метаболизміне CYP2C19 қатысатын препараттарға эзомепразол көрсететін тиімді әсер препаратты көктамыр ішіне енгізген кезде айқындау болады, сондықтан жағымсыз әсерлерді дер мезгілінде анықтау мақсатында көктамыр ішіне енгізетін сәттен бастап 3 күн бойы емделушілерді мұқият қадағалау керек.

Nexium pharmacokinetics asyna darіlіk preparation tardyң аserі

Nexium metabolism without CYP2C19 or CYP3A4 katysada. Nexium men CYP3A4 tezhegishin, clarithromycindi (tаulіgіne 2 ret 500 mg) ishu arkyly bіrge koldanu esomeprazole tәn AUC maninіnіn ekі ese artuyna alyp keledі. Esomeprazoles zhane biriktirilgen CYP3A4 zhane CYP2C19 tezhegishin, mysaly voriconazoles birge koldanu Nexiumge tan AUC maninіn 2 eseden de artyқ ұlғayuyna әkep soқtyrady. Mundai zhagdaylarda Nexium dozasyn retteu seems to be emes. Degenmen, bauyr қyzmetі auyr bұzylғan emdelushіlerde ұzaқ emdeu tagayyndalғanda dozalaudy retteu kazhet boladas.

Overdose of Nexium powder

Symptoms: increased side effects.

Treatment: symptomatic. Specific antidotes are unknown. Nexium binds to plasma proteins, so dialysis is ineffective.

Symptoms: zhagymsyz әserlerdin kүsheyuі.

Emі: belgilerine karay. Arnayy u kaitargylary belgіsіz. Nexium plasma akuyzdarymen baylanysady, sondyktan dialysdin tiimdiligi az.

Pharmacological properties

Pharmacokinetics

Distribution

The volume of distribution at steady state concentration in healthy people is approximately 0.22 l/kg of body weight. Esomeprazole binds to plasma proteins by 97%.

Metabolism and excretion

Esomeprazole is completely metabolized by the cytochrome P450 (CYP) system. The main part is metabolized with the participation of a specific polymorphic isoform CYP2C19, with the formation of hydroxy- and desmethylated metabolites of esomeprazole. The remainder is metabolized by another specific CYP3A4 isoform; in this case, a sulfo derivative of esomeprazole is formed - the main metabolite determined in plasma.

The parameters below reflect, in general, the nature of the pharmacokinetics in patients with an active CYP2C19 enzyme (patients with a rapid metabolism).

The total plasma clearance is approximately 17 l / h after a single dose of the drug and 9 l / h - with repeated doses. The elimination half-life is 1.3 hours with repeated doses of the drug once a day. The area under the concentration-time curve (AUC) increases with repeated administration. This increase is dose- and time-dependent, which is a consequence of a decrease in metabolism during the first passage through the liver, as well as a decrease in systemic clearance, probably caused by the fact that esomeprazole and / or its sulfonic metabolite inhibit the CYP2C19 enzyme.

With daily administration of the drug once a day, esomeprazole is completely eliminated from the plasma in the interval between injections, there is no tendency for the drug to accumulate.

With repeated intravenous administration of esomeprazole at a dose of 40 mg, the average peak plasma concentration is approximately 13.6 µmol / l. When ingested at similar doses, the mean plasma peak concentration is 4.6 µmol/L. Slightly less increase in total exposure (approximately 30%) with intravenous administration of esomeprazole compared with oral administration.

A non-linear increase in AUC is observed after intravenous administration of esomeprazole as a 30-minute infusion (40 mg, 80 mg and 120 mg) followed by a continuous infusion (4 mg / h or 8 mg / h) for 23.5 hours.

The main metabolites of esomeprazole do not affect the secretion of acid in the stomach. When administered orally, up to 80% of the dose of the drug is excreted as metabolites in the urine, the other part - in the faeces. Less than 1% of unchanged esomeprazole is found in the urine.

Features of pharmacokinetics in some groups of patients

Approximately 1-2% of the population has reduced CYP2C19 enzyme activity (patients with a slow metabolism). In such patients, the metabolism of esomeprazole is mainly carried out by CYP3A4, and with repeated oral administration of 40 mg of esomeprazole once a day, the average area under the concentration-time curve is 100% higher than in patients with active CYP2C19 enzyme (patients with rapid metabolism). Mean values ​​of peak plasma concentrations in patients with a slow metabolism are increased by approximately 60%. Similar differences were found with intravenous administration of esomeprazole. The noted features do not affect the dosage and method of administration of esomeprazole.

In elderly patients (71-80 years), the metabolism of esomeprazole does not change significantly.

In patients with mild to moderate hepatic impairment, the metabolism of esomeprazole may be impaired. In patients with severe hepatic impairment, the metabolic rate is reduced, resulting in a doubling of the area under the concentration-time curve for esomeprazole. Therefore, the maximum dose of esomeprazole for patients with severe hepatic impairment is 20 mg/day and should not be exceeded. Tendencies to cumulation of esomeprazole and its main metabolites with the introduction of the drug once a day are not observed.

The study of pharmacokinetics in patients with reduced renal function has not been conducted. Since not esomeprazole itself is excreted through the kidneys, but its metabolites, it can be assumed that the metabolism of esomeprazole in patients with impaired renal function does not change.

Taraluy

Deni sau adamdard tepe-ten concentrationsy kezindegi taralu kölemi shamamen dene salmagyna 0.22 l/kg kuraida. Esomeprazole plasma akuyzdarymen 97% baylanysady.

Metabolism

Esomeprazole P450 (CYP) Negative specifics polymorphs CYP2C19 isoformasyn katysuymen metabolizdenedi, bul oride esomeprazoledin hydroxy-zhane desmethyldengen metabolite tuziledi. Kalgan bөlіgіnіn metabolismі СҮР3А4 baska specifics isoformasymen zhүzege asada; wasps oraida plasmada anyktalatyn negіzgі metabolite - esomeprazole sulfotuyndysy tүziledі.

Tamende keltirilgen parametrler, negizinen, CYP2C19 belsendi enzyme bar emdelushilerdegi (metabolism jyldam emdelushiler) pharmacokinetics of sipatyn corinsteid.

Plasmalyk jalpy clearance preparations bir ret kabyldagannan keyin shamamen sagatyna 17 l zhane kaita kabyldaular kezinde sagatyna 9 l kuraida. Zhartylai shygarylu kezenі preparations tәulіgіne bir ret kaita қabyldaғan kezderde 1.3 sағат құraydy. Kaita engizgende "concentration - uakyt" kisygy astyndagy audany (AUC) ulgayady. Бұл ұлғаю дозаға және уақытқа тәуелді болып, ол бауыр арқылы алғаш өту кезіндегі метаболизм төмендеуінің, сондай-ақ эзомепразолдың және/немесе оның сульфоқұрамды метаболитінің CYP2C19 ферментін тежеуінен туындауы ықтимал жүйелі клиренс төмендеуінің салдары болып саналады.

Preparations tauligine bir ret kүn saiyn engizgende esomeprazole engizuler arasyndagy uziliste plasmadan tolyk shygarylady, preparations zhinaқtalu үrdіsi bіlіnbeidі.

40 mg doses of esomeprazole koktamyr ishine kaita engizilgende plasmadagy zhogary shekti ortasha concentrations shamamen 13.6 µmol/l kuraida. Osygan ұқsas dozalardy іshke қabyldaғanda ortasha plasmalyқ zhogary shekti concentration 4.6 µmol/l құraida. Esomeprazole koktamyr ishine engizilgende, ishu arkyly kabyldaumen salistyrganda, zhalpy exposition (shamamen 30%) birshama az ulgayada.

Esomeprazolds 30-mini-infusia tүrinde (40 mg, 80 mg zhne 120 mg) kooktamyr izhine Engizgenen Kayin dosaga Baylanysyz AUC ұLYAYUYA BAIKALYP, әRIARAY 23.5 SAGATA ZAYLATYYNA NEFUSYAGA (4 mg/SAKI. SAKI.

Esomeprazoledyn negіzgі metabolites and asқazandaғy қyshқyl solinіsіne aser etpeydi. Preparatyn 80%-a deyingі dozasyn іshu arkyly koldanganda metabolitter turinde neseppen, kalgan bolіgі nazhіspen shygarylady. Ozgermegen esomeprazoledyn 1%-danase non-septen tabylady.

Emdelushilerdin keibir toptaryndagy pharmacokinetics of erekshelikteri

Turgyndardyn shamamen 1-2-da (metabolism bayau emdelushiler) Мұндай емделушілерде эзомепразол метаболизмі, негізінен, СҮР3А4 көмегімен жүзеге асады, ал 40 мг эзомепразол тәулігіне бір рет қайта ішке қабылданғанда «концентрация - уақыт» қисығы астындағы орташа ауданы CYP2C19 ферменті белсенді емделушілерде (метаболизмі жылдам емделушілер) 100% жоғары. Metabolism bayau emdelushilerde plasmadagy zhogary shekti concentrationlarynyn ortasha manderi shamamen 60 zhogarylagan. Ұқsas ayyrmashylyқtary esomeprazole koktamyr іshіne engіzgende anyқtalғan. Atalgan erekshelikter esomeprazole dozaluga zhane koldanu tasiline ykpal etpeydi

Where zhastagy emdelushilerde (71-80 zhas) esomeprazole metabolism eleulі ozgermeidі.

Bauyr funktsiyasy zhenil zhane ortasha bұzylғan emdelushilerde esomeprazole metabolism bұzyluy mүmkin. Bauyr funktsiyasynyn auyr bұzyluy bar emdelushіlerde metabolism zhyldamdyғy tөmendegen, bұl esomeprazolғa tәn “concentration - uaқyt” қisyғy astyndaғy audannyң екі eselenuine аkeledі. Sondyktan bauyr funktsiyasy auyr bұzylғan emdelushіlerge arnalғan esomeprazoledyң en zhogary dozasy tәulіgіne 20 mg құraydy zhane ony odan asyrmau kerek. Drugs tauligine bir ret engizgende esomeprazole men onyn negizgi metaboliterinin zhinaqtalu urdisi bolmaida.

Buyrek funktsiyasy tömendegen emdelushilerdіn pharmacokinetics of zertteu zhүrgіzіlmegen. Buyrek arkyly esomeprazoledyn ozinin emes, onyn metaboliterinin shygaryluy zhuzege asatyndyktan, buirek funktsiisy buzylgan emdelushilerdegi esomeprazole metabolism ozgermeydі dep zhoramaldauғa bolady.

Pharmacodynamics

Nexium is the S-isomer of omeprazole and reduces the secretion of hydrochloric acid in the stomach by specifically inhibiting the acid pump in the parietal cells. S- and R-isomers of omeprazole have similar pharmacodynamic activity.

Mechanism of action

Nexium is a weak base, concentrates and passes into an active form in the strongly acidic environment of the secretory tubules of the parietal cells of the gastric mucosa and inhibits the acid pump - the enzyme H +, K + - ATPase, while inhibiting both basal and stimulated acid secretion.

Effect on gastric acid secretion

After taking esomeprazole at a dose of 20 mg or 40 mg for 5 days in patients with gastroesophageal reflux disease (GERD) with symptoms, the gastric pH value was above 4 for an average of 13 and 17 hours out of 24 hours.

The analysis of pharmacokinetic data revealed the relationship between the inhibition of acid secretion and the concentration of the drug in plasma after oral administration (to assess the concentration, the AUC parameter was used - the area under the "concentration-time" curve).

When intravenous administration of 80 mg of esomeprazole as a bolus infusion over 30 minutes, preceding a continuous intravenous infusion of 8 mg / h for 23.5 hours, the intragastric pH value above 4 and above 6 in healthy volunteers was maintained for an average of 21 hours and 11-13 hours out of 24 hours, respectively.

Therapeutic effect achieved as a result of inhibition of acid secretion

Healing of reflux esophagitis with treatment with Nexium at a dose of 40 mg occurs in approximately 78% of patients after 4 weeks of therapy and in 93% of patients after 8 weeks of therapy.

Nexium omeprazoledyn S-isomers of large tabylady zhane parietaldi zhasushalarda kyshkyl sorgysyn specifics tezheu zholymen askazandagy tyz kyshkylynyn solinisin azaitady. Omeprazole S-zhane R-isomers

Aser etu mechanisms

Нексиум әлсіз негіз болып табылады, асқазан шырышты қабығының париетальді жасушалары сөл бөлетін өзекшелерінің аса қышқылды ортасында шоғырланады және белсенді түрге ауысады, әрі қышқылды сорғы – Н+ К+-АТФаза ферментін тежейді, бұл орайда қышқылдың әрі базальді, әрі көтермеленген сөлінісінің тежелуі болады.

Asқazandagy қyshқyl solіnіsіne аserі

Гастро-эзофагеальді рефлюкс ауруына (ГЭРА) шалдыққан, белгілері бар емделушілер 5 күн бойы эзомепразолды 20 мг немесе 40 мг дозада қабылдағаннан кейін 24 сағаттың орташа алынған 13 және 17 сағатында асқазандағы рН мәні 4-тен жоғары болды.

Фармакокинетикалық деректерді талдау ішке қабылдағаннан кейін қышқыл сөлінісін тежеу ​​мен плазмадағы препарат концентрациясының арасындағы өзара байланысты анықтауға мүмкіндік берді (концентрацияны бағалау үшін AUC - «концентрация-уақыт» қисығы астындағы аудан параметрі пайдаланылды).

23,5 cағатқа созылатын 8 мг/сағат ұзақ көктамырішілік инфузияның алдында 30 минут бойы 80 мг эзомепразол болюстік инфузия түрінде көктамыр ішіне енгізілгенде сау еріктілердегі 4-тен жоғары және 6-дан жоғары асқазанішілік рН мәні, тиісінше, 24 сағаттың орташа алғанда 21 сағаты және 11 -13 sagatynda saktaldy.

The drug Nexium is inhibitor a proton pump with high efficiency in the treatment of peptic ulcer in association with Helicobacter pylori, has proven itself in the treatment of reflux gastroesophageal disease. The drug Nexium, when administered parenterally, stops ulcerative bleeding, lowers the secretion of the gastric glands, and when administered intravenously, reduces the manifestations of acute pancreatitis.

An inhibitor with a levorotatory isomer serves as a gastric protector when NSAID therapy is administered in large quantities and for a long time. The dosage spectrum of Nexium is varied - 40,20,10 mg, there is a parenteral form.

Description of the drug

The active substance in the composition of the drug is esomeprazole magnesium trihydrate in the amount of 22.3 mg (tablet 20 mg), which is equal to esomeprazole in the amount of 20 mg. In a 40 mg tablet, the active substance is increased to 40 mg of esomeprazole. in cell Auxiliary components in tablets are presented:

The release form of the drug Nexium

Produced in the form of coated tablets, Nexium 10 mg, 20 mg and 40 mg. Packaged in 7 pieces in aluminum foil blisters, accompanied by instructions for use. The tool is sold in cardboard packaging, on which there is a control of opening the pack for the first time.

pharmachologic effect

It is an isomer and is used to reduce gastric acid secretion through inhibition of the proton pump. The process affects the parietal gastric cells.

Pharmacodynamic features

Esomeprazole is a weakly active substance that exhibits its activity in an acidic medium of high concentration. Such an environment occurs in the secretory glands of the parietal cells of the gastric mucosa, where esomeprazole has a stimulating effect on hydrochloric acid:

Therapeutic prescription in the treatment of reflux esophagitis and healing of the disease occurs after a month of treatment in 77% of patients and after therapy for two months in 94% of patients. In relation to antibiotics of the appropriate action, Helicobacter can be defeated in 90% of patients. If uncomplicated peptic ulcer disease is diagnosed in patients, then in most cases, after a week of Nexium 10 mg or 20 mg, additional use of drugs to reduce the secretion of the glands will not be required.

The effectiveness of tablets is noted when trying to stop bleeding from peptic ulcer, as there is laboratory evidence. During therapy with drugs that lower the production of acid, the concentration of gastrin in the blood plasma becomes higher and the accumulation of chromogranin A (CgA) increases. Such substances in the study of the presence of neuroendocrine tumors can give implausible results. To prevent incorrect readings, the A (CgA) lowering drug is stopped 6 to 15 days before the examination.

In patients treated with esomeprazole for a long time, the number of enterochromaffin-like cells increases, which occurs after an increase in gastrin in the blood plasma, this fact does not affect the clinic of the disease. In patients who have been using acid-reducing agents for a long time, cystic neoplasms of glandular concentration in the stomach area are observed. These are physiological changes after a decrease in acidity; at the end of treatment, these formations decrease and disappear.

As a result of taking inhibitors in the stomach, there is an increase in microbes that are normally always present in humans in the intestinal tract, so there is a small risk of infectious inflammation caused by uncontrollably developing organisms.

In patients at risk taking NSAIDs, such as the elderly or patients with peptic ulcers, Nexium shows effective preventive an action that turned out to be higher than ranitidine in clinical trials. Nexium promotes the healing of existing gastric ulcers of the duodenum and stomach.

Pharmacokinetics in the body

The maximum content in plasma is observed 1.5–2 hours after taking the tablet, the drug is rapidly absorbed, but it should be noted that esomeprazole is destroyed in an acidic environment, so the drug is produced with an outer shell that staunchly resists gastric juice.

biological availability active substance when using a dosage of 40 mg is 65% and rises to 89% in the case of daily administration of the drug. For a dosage of 20 mg, this bioavailability shows 51 and 69%, respectively. In humans, the distribution occurs at the rate of 0.22 liters per kilogram of weight.

Esomeprazole actively combines with blood proteins, which is about 97%. Due to the intake of the drug during meals, the absorption of the drug may slightly decrease, but this does not reduce the inhibition of hydrochloric acid. The main part of the substance is metabolized with the participation of specific isoenzymes (polymorphic CYP2C19). As a result, esomeprazole decomposes into demethylated and hydroxylated metabolites.

Metabolites of the main action do not affect for acid secretion in the stomach. When using tablets, about 80% of them are excreted through the kidneys, the remaining number leaves the body with feces. Unchanged esomeprazole in the urine is determined by about 1%.

Esomeprazole activity in some patients

Some patients have decreased activity of the required CYP2C19 isoenzyme for various reasons, so metabolism occurs under the influence of CYP3A4. In this case, with daily use of a 40 mg tablet, the average AUC is 100% higher than in ordinary people. In patients of the elderly group, the metabolism does not change compared to the young.

Indicators maximum the content of the substance in people with reduced activity of the required isoenzyme is increased by 61% compared to the usual cases. This variety of indicators does not affect the way Nexium is administered. In women, when using the Nexium tablet for the first time, the AUC is 30% higher than in the male population. But subsequent applications smooth out this difference in performance and no differences in pharmacokinetics were noticed.

In cases of moderate and mild hepatic insufficiency, the absorption of the substance may be impaired. If we talk about a severe degree of insufficiency in the work of the liver, then the metabolism is so disturbed that the AUC indicators increase by 2 times. Pharmacokinetics in patients with renal insufficiency has not been sufficiently studied, but since esomeprazole metabolites are excreted through the kidneys, the metabolism in this group of patients can be considered unchanged.

Indications for use according to the instructions

Reflux gastroesophageal disease

According to the drug instructions appointed in the following cases:

Ulcers in the gastrointestinal tract

Nexium is used as therapy during treatment:

• duodenal ulcers that occur when infected with the bacterium Helicobacter;
• to prevent the recurrence of peptic ulcers caused by the bacterium Helicobacter;
• for long-term therapy in patients suffering from ulcerative bleeding caused by intravenous administration of drugs to reduce gastric secretion, as a prophylactic against the occurrence of recurrent bleeding.

In patients with prescribed NSAID therapy, Nexium is used in cases:

• for tightening gastric ulcers that have appeared from the long-term use of non-steroidal anti-inflammatory drugs;
• prevention of the appearance of ulcers on the mucous membrane of the stomach and intestines in patients using NSAIDs, as in patients at risk.

A contraindication to the use of the drug is an allergic reaction to esomeprazole, which can be replaced in the drug by benzimidazoles. Nexium tablets contain sucrose in their composition, because of this they are not recommended for patients with intolerance to this substance, suffering from glucose-galactose malabsorption or having a history of sucrose-isomaltose deficiency.

Special instructions for instructions

Sometimes when using tablets in therapy, unwanted side effects manifestations:

When such symptoms appear, it is necessary to check the patient for malignant tumors, since Nexium therapy can alleviate the symptoms and the disease cannot be recognized in time.

In some cases, after long-term treatment with omeprazole, there may be gastritis with an atrophic course. If there is a need to take Nexium for more than a year, then patients should be warned about the inevitability of going to the doctor after a change in symptoms, or they need constant monitoring by the attending doctor.

Interaction with other drugs

When prescribing Nexium, one should be guided by its joint combination with other therapeutic agents, since the content of esomeprazole in the blood plasma undergoes constant fluctuations. When using Nexium for the eradication of Helicobacter bacteria, care should be taken to ensure the compatibility of all components of therapy. Consider the following combinations:

• belong to potent inhibitors of the CYP3A4 isoenzyme, therefore, when prescribing simultaneous treatment of drugs (cisapride) with absorption in the presence of this enzyme, one should be interested in the possible simultaneous use of these two drugs;
• clopidogrel and esomeprazole cannot be used simultaneously in the treatment, since their interaction leads to a decrease in the active amount (by 40%) and a decrease in the level of inhibition of platelet aggregation (by 14%).

As a result of control over clinical trials of esomeprazole and omeprazole, data on the relationship of bone fractures of the extremities due to treatment with proton pump inhibitors were not confirmed. But for patients requiring treatment with Nexium, against the background of existing osteoporosis, constant medical support is required.

When driving, one should take into account the fact that the use of Nexium in some cases leads to visual impairment, drowsiness and dizziness, one should drive with caution. The same precautions apply to other jobs requiring increased attention.

Release of the drug and price

The drug is manufactured in Sweden, where primary packaging is produced, and secondary consumer packaging and quality control at the outlet is carried out in the Kaluga region. The shelf life of the drug is 3 years from the date of issue, the drug is sold by prescription and it is not recommended to use it after the expiration date. Prices in different cities of Russia for a package of 7 tablets of 4 mg:

• in Moscow the price is 1365 rubles;
• in St. Petersburg - the price is 1575 rubles;
• in Nizhny Novgorod - the price is 1443 rubles;
• in Novosibirsk - the price is 1488 rubles.

The price may vary depending on the dosage of the active substance in the tablet. The cost is high and not all patients can afford it. But, having tried this drug once, patients try not to switch to other analogues.

Feedback: A highly effective drug with a specialized effect on the production of hydrochloric acid in the stomach, helps patients with incipient and developing ulcers, after using the drug, after a week, the release of hydrochloric acid is reduced to 90%. The only thing that patients should do is to follow a diet, as a change in the acidity of the stomach leads to difficulties in digesting food. A wide range of dosing tablets makes it convenient to use. Analogues of the drug, which have a lower price, according to patients, lose to some extent, meanwhile, Nexium, at a high cost, is in constant demand among those who once tried this wonderful remedy.

Gastroenterologist V.P. Klymenko

Feedback: I have been using this drug for a long time (half a year already). I had to organize small breaks to restore the flora of the stomach and intestines. Vomiting and diarrhea began, for sure my body can not quite accept such changes. But in terms of the effect on the disease (I have a stomach ulcer), I could not find analogues with such an effect, although many different drugs were tried. The ulcer scars or decreases, but after some time during the examination they are detected again. Before taking the drug, I listened to a lot of reviews, I didn’t hear any bad ones, so I decided to use it myself. The Nexium remedy perfectly heals, I advise many to use this drug.

Vasily Kondrashov

Review: The doctor prescribed a course of non-steroidal anti-inflammatory drugs for me, but at this age (I am 65 years old), these NSAIDs give the formation of ulcers in the stomach. At first, heartburn began to torment, then nausea increased, and even vomiting began to appear. For a long time I drank folk remedies, because, in contrast to the arguments of the doctor, I believed that traditional medicine would get rid of everything. But gradually my health worsened, and the doctor prescribed Nexium for me after the ultrasound. Reviews about this drug were good, even from my friends, so I decided to take it, despite the high price. Now there are scars instead of ulcers, thanks to Nexium medicine. Analogues, though cheaper, but health is more expensive.

Margarita Lvovna, Moscow

Feedback: The drug is distinguished by enviable efficiency, since after the third day of use, vomiting and nausea have already ceased to torment. And I used Nexium to treat duodenal ulcers. At the same time, the doctor prescribed antibiotics for me, but the drug was in contact with them exactly, and there were no side effects, which is just wonderful. Despite the cost (the tablets are only enough for 7 days), there is simply no point in taking other analogues.

Nexium (generic international name - esomeprazole) is a medication, the action of which is aimed at reducing the production of hydrochloric acid by the gastric glands.

Due to the suppression of secretory activity, the agent helps to reduce the level of acidity and is used in the complex therapy of various conditions associated with excessive acid secretion. About how to take the drug and how to choose the right dose, the instructions for the use of Nexium or the attending physician will tell.

Application

A drug such as Nexium INN is available in the following forms:

• 20 mg and 40 mg pills.
• Granules, pellets of 10 mg.
• Lyophilizate 40 mg. This form is used exclusively for injection.

Therefore, the drug - "Nexium" has 2 main variations of application:

Nexium tablets are most often used, as this is the most familiar and convenient option. The rare use of pellets is explained by the fact that a smaller amount of the active substance is contained in the composition. As a rule, the drug in Nexium pills is used for children or patients who are not able to swallow the pill. The drug "lyophilizate" Nexium is used when it is impossible to use the drug orally.

The composition of the drug includes the active substance esomeprazole in different dosages. For example, Nexium tablets contain 20 mg-40 mg of the active ingredient, granules - 10 mg each, and for injections - 40 mg in a vial. Therefore, it is possible to come across such a name as "Nexium 40, 20 or 10 mg" and "Nexium powder". This kind of terminology is unofficial, but widely used.

The composition of 1 pill fits:

1. Esomeprazole.
2. Glycerol monostearate, hyprolose, hypromellose, dye (E172), cellulose, magnesium stearate, copolymer of methacrylic and ethacrylic acids, paraffin, polysorbate, macrogol, crospovidone, titanium dioxide, talc, triethyl citrate.

The composition of 1 package of granules includes almost the same number of auxiliary components. Dextrose is added to this form.

The composition of 1 bottle of lyophilizate includes: esomeprazole, disodium edetate dihydrate, sodium hydroxide.

In pharmacies, Nexium pills come in packages that are equipped with a first opening test. You can buy a package with 1, 2 or 4 blisters of 7 pills each. Pellets - granules in sachets (10 mg) are assembled in 10 or 28 pieces. For injection, a medicine such as Nexium is sold in 10 vials per pack.

Pellets or granules have a yellowish or brown color. Pills - oval-shaped with a pinkish color, on the front side the inscription "40 mg" or "20 mg", depending on the amount of active substance, on the reverse side of the letter "A / EI". Lympholisate is represented by a mass of white color.

Important! The medication is released strictly according to the prescription.

Therapeutic influence

This drug is designed to reduce the release of hydrochloric acid. This kind of influence is of considerable importance, since the need to reduce acidity is a key moment in the course of the treatment of many diseases. According to the mechanism of action, the drug is classified as a proton pump inhibitor.

A characteristic feature of the drug is the ability to eliminate excessive production of acid. The agent begins to act after 1 hour after ingestion.

It should be noted that esomeprazole does not have acid resistance. For this reason, in the manufacture of products of this group, the active ingredients are wrapped in a shell that is not affected by an acidic environment.

Many patients have a question how to take Nexium: before meals or after? It should be noted that after taking the pill, its rapid absorption from the gastrointestinal tract is noted.

Experts note that if the drug is taken with food, then the absorption of the active substance will be significantly inhibited, but this practically does not affect the effectiveness of the drug. The summary states that the intake of the drug and food should be separated by about 30-60 minutes. Therefore, you need to take Nexium before meals or after a meal with an interval of 30-60 minutes.

The use of a medication of 40 mg per day for 4 weeks allows 78% to cure gastroesophageal reflux disease. If the treatment is extended to 8 weeks, then the percentage of cured patients rises to 90.

The use of a drug of 20 mg in combination with antibiotics contributes to the elimination of Helicobacter in 90% of patients after 2 weeks. In addition, patients who used Nexium in the treatment of gastric or duodenal ulcers should not, upon completion of therapeutic measures, drink other aids for scarring ulceration.

When appointed

Medication Nexium and its indications for use will help get rid of the symptoms and foci of inflammation. Nexium is prescribed for the treatment and prevention of a number of pathologies.

These include:

1. Gastroesophageal reflux disease.
2. Ulcer of the stomach and duodenum.
3. Diseases of the stomach that arose against the background of prolonged use of NVPS.
4. Other diseases associated with increased secretion of hydrochloric acid.

1. Auxiliary measures for incurable esophagitis, aimed at preventing exacerbation.
2. Elimination of symptoms.
3. Treatment of erosive GERD.

Peptic ulcer of the stomach and duodenum:

1. Treatment of the disease provoked by Helicobacter pylori.
2. Relapse prevention.

Pathologies of the stomach that have arisen in patients who have been taking NSAIDs for a long time:

1. Therapy of ulcers caused by taking medications from the NVS group.
2. Relapse prevention.

Indications for the use of lyophilisate:

1. GERD in conjunction with esophagitis.
2. Scarring and prevention of peptic ulcers.
3. Prevention of blood loss from a peptic ulcer.

Important! Lyophilizate Nexium for children is prescribed from 1 year.

Contraindications

Nexium has contraindications that must be taken into account. The tool does not need to be used:

1. With congenital fructose intolerance.
2. Up to 12 years old.
3. After 12 years can be used only in the presence of GERD.
4. With increased susceptibility to the components.

Nexium should be replaced with its analogue in such situations:

1. Hypersensitivity to the active substance.
2. Diseases of the kidneys.
3. GW period and pregnancy.

Rules for use and dosage

Before you start taking it, you need to familiarize yourself with the drug Nexium and its instructions for use. The use of the drug is intended for oral administration before or after meals. The medicine should be swallowed whole with plenty of water.

Important! It is forbidden to crush or chew the medicine.

For patients who have difficulty swallowing, the medication can be diluted in 0.5 tbsp. liquids. For patients who do not have the opportunity to swallow pills at all, the introduction is made by a nasogastric tube.

Pellets and granules are applied orally. To receive 10 mg of the drug, you need to dilute 1 sachet in 15 ml of liquid. Patients taking 20 mg of the drug will need to dissolve 2 packets in 30 ml of liquid.

The lyophilisate is intended for injection and infusion. The dosage and frequency of use is determined by the doctor.

Negative influence

Nexium has side effects that should be considered during therapy.

Side effects of Nexium are expressed as follows:

1. CNS. Often the drug causes a migraine. There may also be a taste disorder. Sometimes there is lethargy, dizziness.
2. At times, bronchospasm may occur.
3. On the part of the gastrointestinal tract, nausea, vomiting, pain in the abdominal cavity, bloating, upset stool can be observed.
4. The reaction to the drug may be irritation, dermatitis, rash.
5. Vision may be impaired.
6. General disorder: profuse sweating, malaise.

Signs of an overdose: weakness and upset of the digestive system.

During pregnancy

Particular attention should be paid to the fact that it is undesirable to prescribe Nexium during pregnancy, since there is no verified information about its effect on a woman's body during this period. There is also no information about whether the drug passes into the mother's milk. Therefore, during the GV period, the medicine should not be used either.

Analogues

Help for people with acid-dependent pathologies was the release of the medication Emaner. Despite the fact that Nexium analogs may contain different active ingredients, this analog contains esomeprazole. Therefore, this analogue is considered an excellent replacement for Nexium. Emenera is produced in coated capsules. The tool has the same indications for use as Nexium.

Photos, videos and reviews on the effect of this analogue on the body can be viewed on the Runet. It should be noted that the reviews about this medication are different, for example, “I didn’t like Emanera. It does not relieve the burning sensation, I additionally drink Gaviscon.

Important! Patients who take the drug for a long time must necessarily undergo consultations on time, since a large dosage of the drug can significantly increase the risk of fractures.

The composition of Emaner includes sucrose, as a result of which the drug is contraindicated in patients with fructose intolerance.

The effectiveness of the impact of any acid-blocking drug is determined primarily by the genetic characteristics of the patient, the list of medications used. Do not choose your own medicines for treatment. An incorrectly chosen drug or an incorrect dosage can adversely affect health. The purpose of the drug and its dosage should be selected individually on the basis of examination and examination.

www.kogdaizzhoga.com

Nexium

Compound

As part of tablets, esomeprazole magnesium trihydrate 22.3 mg or 44.5 mg + excipients (hyprolose, E172, magnesium stearate, glycerol monostearate, hypromellose, triethyl citrate, copolymer of ethacrylic and methacrylic acids, macrogol, crospovidone, paraffin, polysorbate 80, stearyl fumarate sodium, macrogol, E171, sucrose, talc).

Mass for solution preparation: esomeprazole 40 mg + sodium hydroxide and disodium dihydrate edetate.

Release form

Nexium 20 mg and Nexium 40 mg are coated tablets, oblong, convex. Color - pink, 20 mg - lighter, 40 mg - darker. The dosage is engraved on one side of the tablet, and the inscription A / EH or A / EI on the other. Cardboard packages of 7, 14, 28 pieces.

Powder - pressed white mass for the preparation of a solution. In glass bottles of 5 ml.

pharmachologic effect

proton pump inhibitor.

Pharmacodynamics and pharmacokinetics

The active substance is a derivative of omeprazole (its S-isomer). Esomeprazole reduces the activity of hydrochloric acid secretion on the gastric mucosa by suppressing the proton pump (enzyme H + K + -ATPase) of parental cells on the walls of the stomach.

When combined with antibiotics, it is effective against Helicobacter pylori, which is usually the cause of stomach ulcers.

As a specific response to decreased acid secretion, benign cysts may form and plasma gastrin levels may increase.

1-2 hours after taking the drug is already beginning to have an active effect on the level of hydrochloric acid. About 90% of the active substance binds to plasma proteins. Metabolized, excreted in urine and feces.

Pharmacokinetics in people with reduced CYP2C19 enzyme activity and severe liver disease differs from the main group of people. It is necessary to make a dose adjustment of the drug.

Indications for use

Tablets:

• erosive reflux esophagitis, treatment and supportive care;
• gastric and duodenal ulcer (treatment and prevention, in combination with other means);
• pathological hypersecretion of the glands of the stomach;
• people who take NSAIDs for a long time and treatment of diseases caused by their intake;
• prevention and treatment of bleeding from peptic ulcers;
• idiopathic hypersecretion.

A solution for intramuscular administration is prescribed if it is impossible to take the tablet form of the drug.

The indication is:

• gastroesophageal reflux disease;
• peptic ulcers, including prevention of bleeding after endoscopic hemostasis.

Contraindications

The drug is contraindicated:

• patients with allergies to any of the components, including fructose (for tablet form);
• when taking atazanavir or nelfinavir;
• children under 12 years old.

In the case of gastroesophageal reflux disease, the drug may be prescribed to children over 12 years of age.

Severe renal failure is not a direct contraindication to the use of the drug, but in this case, caution should be exercised.

Side effects

• nausea, headache, constipation, pain in the epigastric region;
• allergic reactions on the skin, sleep disturbance, paresthesia;
• bronchospasm, stomatitis, anaphylactic shock, myalgia, agitation, arthralgia;
• possible inflammation and redness at the injection site with intravenous and intramuscular use.

Application instruction of Nexium (Way and dosage)

Tablets are drunk whole or dissolved in water without gas. If necessary, the dissolved tablet can be administered through a nasogastric tube.

How to take, before meals or after?

According to the instructions for use of Nexium, food intake practically does not affect the effectiveness of the product. In the treatment and prevention of ulcers, as a rule, the daily dose of the drug is 20 mg, divided into two doses in combination with other drugs. The course is 7 days.

When carrying out acid-suppressing therapy, Nexium 40 mg is prescribed, every day for a month.

In conditions caused by taking NSAIDs, the daily dosage is 20-40 mg. The course is up to two months.

In severe liver disease, the daily dose should not exceed 20 mg.

Dosage for children (12+)

With erosive reflux esophagitis, the daily dose is 40 mg, at one time, for one month. In other cases, it is enough to take 20 mg of the drug per day.

Intramuscular injections

If necessary, injections of the drug or intravenous infusions may be prescribed instead of the tablet form. Dosage matches. The time of intramuscular injection should be at least three minutes.

Intravenously - from 10 minutes to half an hour. The drug is diluted with 0.9% solution of sodium chloride, without mixing with other drugs.

You can store the prepared preparation for no more than 12 hours, it is best to use it immediately after preparation.

Overdose

In people who used 0.28 grams of the drug, weakness and discomfort in the gastrointestinal tract were noted.

The medicine has no specific antidote. Treatment is symptomatic.

Interaction

When esomeprazole is combined with drugs such as ketoconazole and itraconazole, the absorption of drugs from the gastrointestinal tract may be impaired.

Atazanavir, nelfinavir, omeprazole, when combined with Nexium, become less effective. However, when combined with saquinavir, its serum concentration increases.

Simultaneous reception with drugs in the assimilation of which CYP2C19 is involved will lead to an increase in their effect. These drugs include imipramine, diazepam, clomipramine, citalopram, phenytoin.

For persons suffering from epilepsy, the remedy should be taken with caution. Epilepsy drugs (phenytoin) do not mix well with Nexium.

With caution, combine the drug with warfarin and cisapride.

Terms of sale

Need a prescription.

Storage conditions

Dark, cool place, away from children.

Store the bottle with the powder in its original packaging, in the light - no more than a day.

Best before date

3 years - pills.

2 years - powder for solution preparation.

Analogues of Nexium

What can replace the drug? In fact, the synonyms of the drug are: Nexpro, Ezoxium, Esonexa, Ezoks, Ezolong.

The most common analogues: Esomealox, Emanera, Barol, Esomeprazole, Veloz, Geerdin, Controloc, Ozol, Omez, Normicid, Rabimak, Panum, Pariet, Razol, Ultop.

The price of analogues can differ significantly from the original.

Which is better: Pariet or Nexium?

In general, the question of the use of a particular agent should be determined individually, depending on the results of the tests, the sensitivity of the body to a particular agent. However, among experts there is an opinion that Pariet is somewhat more effective than Nexium. Its action comes faster, the daily dosage is less, and side effects are less common. Both tools are not cheap, which is fully justified by their effectiveness.

Reviews about Nexium

Doctors' comments about Nexium: In general, proton pump inhibitors are currently the most effective drugs that regulate acidity in the gastrointestinal tract. Nexium is a very good drug of this series, with a pronounced strong therapeutic effect.

Reviews on the forums are good. The medicine is quite effective, relief comes quickly. Side effects appear infrequently. The disadvantage is the high cost.

Nexium price (where to buy)

The price of Nexium 40 mg tablets is about 1750 rubles for 14 pieces.

The price of Nexium 20 mg in Moscow is 1310 rubles for 14 pieces.

You can buy pellets and granules of the drug for 2061 rubles per 10 mg, 28 pieces each.

• Internet pharmacies in RussiaRussia
• Internet pharmacies of UkraineUkraine
• Internet pharmacies of KazakhstanKazakhstan

WER.RU

• Nexium tablets 40 mg 14 pcs.
• Nexium tablets 20 mg 14 pcs.
• Nexium pellets 10 mg 3042.7 mg 28 pcs. AstraZeneca AB [AstraZeneca]
• Nexium tablets 20 mg 28 pcs.
• Nexium tablets 40 mg 28 pcs.

ZdravZone

• Nexium 40mg №14 tablets AstraZeneca
• Nexium 20mg №14 tablets AstraZeneca
• Nexium 20mg №7 tablets AstraZeneca
• Nexium liof. for the preparation of a solution for intravenous injection. 40mg #10AstraZeneca
• Nexium 40mg №28 tabletsAstraZeneca

Pharmacy IFK

• NexiumAstra Zeneca, Sweden
• Nexium pellets p/kish/o gran.d/prig. suspensions 10mg pack. №28Astra Zeneca, Switzerland
• NexiumAstraZeneca/ ZiO-Zdorovye CJSC, Russia
• NexiumAstraZeneca/ ZiO-Zdorovye CJSC, Russia

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Pharmacy24

• Nexium tablets 20mg №14Zeneca (UK)
• Nexium tablets 40mg №14Zeneca (UK)
• Nexium powder for solution for injection 40mg №10Zeneca (UK)
• NexiumAstraZeneca (Sweden)

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BIOSPHERE

• Nexium 20 mg No. 14 tablets p.o. Astra Zeneka AB (Sweden)
• Nexium 40 mg No. 14 tablets p.o. Astra Zeneka AB (Sweden)

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NOTE! Information about medicines on the site is a general reference, collected from publicly available sources and cannot serve as a basis for making a decision on the use of medicines in the course of treatment. Before medicine use Nexium surely consult with the attending physician.

medicalmed.ru

Nexium

Nexium is a drug that helps to reduce the secretion of hydrochloric acid in the stomach.

Release form and composition

Nexium is available in the following dosage forms:

• Enteric-coated pellets and granules for suspension for oral administration: pale yellow, brown granules may be found, of various sizes (3042.7 mg in triple laminated bags, 28 bags in a cardboard box);
• Film-coated tablets: oblong, biconvex, on a break - white with yellow patches; 20 mg each - light pink, on one side engraved in the form of a fraction "A / EH", on the other - "20 mg"; 40 mg each - pink, on one side engraved in the form of a fraction "A / EI", on the other - "40 mg" (7 pcs in blisters, 1, 2 or 4 blisters in a cardboard box);
• Lyophilizate for the preparation of a solution for intravenous administration: almost white or white compressed mass (in glass bottles of 5 ml, 10 bottles in paper racks, 1 rack in a cardboard box with first opening control).

The composition of 1 package of pellets and granules includes:

• Active ingredient: esomeprazole - 10 mg (in the form of magnesium esomeprazole trihydrate - 11.1 mg);
• Auxiliary components: anhydrous citric acid - 4.9 mg; giprolose - 32.2 mg; talc - 8.4 mg; copolymer (1:1) of ethyl acrylate and methacrylic acid - 9.5 mg; sugar, spherical granules (sucrose, spherical granules ranging in size from 0.25 to 0.355 mm) - 7.4 mg; hypromellose - 1.7 mg; dextrose - 2813 mg; magnesium stearate - 0.65 mg; triethyl citrate - 0.95 mg; glycerol monostearate 40-55 - 0.48 mg; polysorbate 80 - 0.27 mg; xanthan gum - 75 mg; dye crospovidone - 75 mg; iron oxide yellow - 1.8 mg.

The composition of 1 tablet includes:

• Active ingredient: esomeprazole - 20 or 40 mg (in the form of magnesium esomeprazole trihydrate - 22.3 or 44.5 mg);
• Auxiliary components (tablets of 20/40 mg, respectively): sodium stearyl fumarate - 0.57 / 0.81 mg; macrogol - 3 / 4.3 mg; magnesium stearate - 1.2 / 1.7 mg; giprolose - 8.1 / 11 mg; glyceryl monostearate 40-55 - 1.7 / 2.3 mg; microcrystalline cellulose - 273/389 mg; hypromellose - 17/26 mg; red dye iron oxide (E172) - 0.06 / 0.45 mg; yellow dye iron oxide (E172) - 0.02 / 0 mg; copolymer (1:1) of methacrylic and ethacrylic acid - 35/46 mg; paraffin - 0.2 / 0.3 mg; polysorbate 80 - 0.62 / 1.1 mg; triethylcitrate - 10/14 mg; crospovidone - 5.7 / 8.1 mg; sugar, spherical granules (sucrose, spherical granules ranging in size from 0.25 to 0.355 mm) - 28/30 mg; talc - 14/20 mg; titanium dioxide (E171) - 2.9 / 3.8 mg.

The composition of 1 bottle of lyophilisate for the preparation of an injection solution includes:

• Active ingredient: esomeprazole - 40 mg (in the form of esomeprazole sodium - 42.5 mg);
• Auxiliary components: disodium edetate dihydrate - 1.5 mg; sodium hydroxide - 0.2-1 mg.

Indications for use

• Erosive reflux esophagitis (treatment);
• Peptic ulcer associated with Helicobacter pylori (relapse prevention);
• Condition after healing of erosive reflux esophagitis (long-term maintenance treatment with a preventive purpose);
• Duodenal ulcer associated with Helicobacter pylori (treatment);
• Condition after bleeding from a peptic ulcer: after intravenous use of drugs that reduce the secretion of the gastric glands (long-term acid-suppressing therapy to prevent relapse);
• Gastroesophageal reflux disease (symptomatic treatment);
• Gastric ulcer associated with the use of non-steroidal anti-inflammatory drugs (treatment for the purpose of healing);
• Gastric and duodenal ulcer associated with the use of non-steroidal anti-inflammatory drugs (prophylaxis in patients at risk);
• Zollinger-Ellison syndrome or other conditions accompanied by pathological hypersecretion, including idiopathic hypersecretion (treatment).

injection solution

Nexium in the form of an injection solution is used as an alternative when it is impossible to take the drug inside.

The solution is prescribed for adults in the presence of the following indications:

• Gastroesophageal reflux disease with esophagitis and / or pronounced signs of reflux disease (treatment);
• Peptic ulcers associated with the use of non-steroidal anti-inflammatory drugs (prophylaxis in patients at risk);
• Peptic ulcers associated with the use of non-steroidal anti-inflammatory drugs (treatment for the purpose of healing);
• Bleeding from a peptic ulcer after endoscopic hemostasis (prevention of recurrence).

For children aged 1-18 years, Nexium is prescribed for gastroesophageal reflux disease against the background of erosive reflux esophagitis and / or severe symptoms of reflux disease.

Contraindications

• Glucose-galactose malabsorption, sucrase-isomaltase deficiency, hereditary fructose intolerance (tablets, oral suspension);
• Co-administration with nelfinavir and atazanavir;
• Hypersensitivity to the components of the drug, as well as to substituted benzimidazoles.

Nexium should be used with caution in severe renal failure.

For children, depending on the dosage form, the drug is prescribed:

• Suspension for oral administration: from 1 year old (weighing at least 10 kg) in the treatment of erosive esophagitis and symptomatic therapy of gastroesophageal reflux disease; from the age of 12 in the treatment of gastroesophageal reflux disease;
• Tablets: from the age of 12 in the treatment of gastroesophageal reflux disease;
• Injectable solution: from 1 year in the treatment of gastroesophageal reflux disease.

During pregnancy, Nexium can be prescribed only after the doctor has assessed the ratio of benefits to the health of the mother with the risk to the fetus. If necessary, the use of the drug during lactation, breastfeeding should be interrupted.

Method of application and dosage

Tablets, oral suspension

Nexium tablets are swallowed whole (without crushing or chewing), washing down with liquid. If swallowing is difficult, a single dose of the drug can be dissolved in 1/2 cup of non-carbonated water. The resulting suspension of microgranules should be drunk for 30 minutes, then the glass should be filled again with 100 ml of water and the suspension should be drunk with the remnants of the dissolved tablet.

Granules and pellets for the preparation of a suspension for oral administration Nexium are prescribed, as a rule, for children and patients with problems with swallowing. To obtain 10 mg, the contents of 1 sachet must be dissolved in 15 ml of water. Before taking, you need to wait a few minutes until a suspension forms. The resulting suspension should be taken within 30 minutes, then the glass should be filled again with the same volume of water and the suspension should be drunk with the remnants of the dissolved granules. Use carbonated water to obtain a suspension, as well as chewing or crushing microgranules should not be.

If it is difficult to swallow diluted tablets or suspensions, they are administered through a nasogastric tube.

• Erosive reflux esophagitis (treatment; prescribed for children 1-11 years old weighing from 10 kg in the dosage form of a suspension for oral administration): a single dose for children weighing 10-20 kg - 10 mg, more than 20 kg - 10-20 mg, frequency of use - 1 time per day, course duration - 8 weeks;
• Erosive reflux esophagitis (treatment; prescribed for adults and children from 12 years of age): single dose - 40 mg, frequency of use - 1 time per day, course duration - 4 weeks. It is possible to conduct an additional course of the same duration if the symptoms of the disease persist or if the cure for esophagitis does not occur after one course;
• Erosive reflux esophagitis (long-term maintenance therapy after healing to prevent relapse; prescribed for adults and children from 12 years of age): single dose - 20 mg, frequency of use - 1 time per day;
• Gastroesophageal reflux disease (symptomatic treatment; prescribed to children aged 1-11 years with a body weight of 10 kg in the dosage form of a suspension for oral administration): single dose - 10 mg, frequency of use - 1 time per day, course duration - up to 8 weeks;
• Gastroesophageal reflux disease without esophagitis (symptomatic therapy; prescribed for adults and children from 12 years of age): single dose - 20 mg, frequency of use - 1 time per day. If after a month from the start of treatment the symptoms do not disappear, an additional examination is recommended. After the condition improves, it is possible to switch to the “as needed” mode of using Nexium, which involves taking the drug when symptoms of the disease occur until they are removed in a single dose of 20 mg with a frequency of administration 1 time per day. For patients taking non-steroidal anti-inflammatory drugs and patients who are at risk of developing gastric or duodenal ulcers, on-demand therapy is not recommended;
• Peptic ulcer of the stomach and duodenum for the eradication of Helicobacter pylori, as well as duodenal ulcer associated with Helicobacter pylori (combination therapy, as well as prevention of recurrence of peptic ulcers associated with this bacterium in patients with peptic ulcer; prescribed for adults): Nexium - 20 mg, clarithromycin - 500 mg, amoxicillin - 100 mg, the frequency of taking each of the drugs - 2 times a day, the duration of the course - 7 days;
• Conditions after bleeding from a peptic ulcer after intravenous use of antisecretory drugs (long-term acid-suppressing therapy and prevention of relapse; prescribed for adults): single dose - 40 mg, frequency of use - 1 time per day, course duration - 30 days;
• Gastric ulcer associated with prolonged use of non-steroidal anti-inflammatory drugs (treatment for the purpose of healing; prescribed for adults): single dose - 20 or 40 mg, frequency of use - 1 time per day, course duration - 1-2 months;
• Ulcer of the stomach and duodenum associated with the intake of non-steroidal anti-inflammatory drugs (prevention; prescribed for adults): single dose - 20 or 40 mg, frequency of use - 1 time per day;
• Conditions characterized by pathological hypersecretion, including idiopathic hypersecretion and Zollinger-Ellison syndrome: the initial single dose is 40 mg (then the dose is selected individually), the frequency of use is 2 times a day, the doctor determines the duration of the course based on the clinical picture of the disease.

injection solution

Intravenous administration of the drug is indicated when oral administration is not possible. Parenteral use of Nexium, as a rule, is short-lived, and it is recommended that the patient be switched to taking the drug in the form of a suspension or tablets as soon as possible.

Only 0.9% sodium chloride solution can be used to dissolve the lyophilisate. It is recommended to administer the drug immediately after its preparation. If necessary, it can be stored at temperatures up to 30 ° C for 12 hours.

Do not mix or inject the Nexium injection solution simultaneously with other drugs.

The dosage regimen is determined by the indications (daily dose with a frequency of use 1 time per day):

• Esophagitis in gastroesophageal reflux disease (treatment): children 1-11 years old weighing up to 20 kg - 10 mg, children 1-11 years old weighing from 20 kg - 10 or 20 mg, children from 12 years old and adults - 40 mg;
• Gastroesophageal reflux disease (symptomatic treatment): children 1-11 years old - 10 mg, children from 12 years old and adults - 20 mg;
• Peptic ulcers associated with taking non-steroidal anti-inflammatory drugs (treatment for the purpose of healing): adults - 20 mg;
• Peptic ulcers associated with the use of non-steroidal anti-inflammatory drugs (prophylaxis): adults - 20 mg.

In order to prevent recurrence of bleeding from a peptic ulcer after endoscopic hemostasis, as a rule, Nexium 80 mg is used as an intravenous infusion over 30 minutes, followed by an extended intravenous infusion at a dose of 8 mg per hour for 72 hours. To suppress the secretion of acid after the end of parenteral use of the drug, it is recommended to conduct antisecretory therapy (for example, for 1 month, esomeprazole 1 time per day, 40 mg).

The duration of the introduction of Nexium is:

• Intravenous injections: at a dose of 10, 20 and 40 mg - from 3 minutes;
• Intravenous infusions: at a dose of 10, 20 and 40 mg - 10-30 minutes; 80 mg - 30 minutes; 8 mg / h - 71.5 hours (extended infusion).

When bleeding from a peptic ulcer in patients with severe hepatic impairment, Nexium is prescribed 80 mg as an intravenous infusion over 30 minutes, followed by an extended intravenous infusion at a maximum dose of 4 mg per hour for 71.5 hours.

Dosage adjustments in elderly patients should not be made.

In case of impaired renal function during the use of Nexium in any dosage form, the dose should not be adjusted. In patients with renal insufficiency, the drug is prescribed with caution.

Due to limited clinical experience, Nexium should be used with caution in patients with severe hepatic impairment. The maximum daily dose in adults and children from 12 years old should not exceed 20 mg, in children 1-11 years old - 10 mg.

Side effects

• Musculoskeletal system: rarely - myalgia, arthralgia; very rarely - muscle weakness;
• Nervous system: often - headache; infrequently - drowsiness, paresthesia, dizziness; rarely - a violation of taste;
• Urinary system: very rarely - interstitial nephritis;
• Hematopoietic system: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia;
• Gastrointestinal tract: often - vomiting and / or nausea, constipation, abdominal pain, flatulence, diarrhea; infrequently - dry mouth; rarely - stomatitis, candidiasis of the gastrointestinal tract; very rarely - microscopic colitis confirmed by histological studies;
• Respiratory system: rarely - bronchospasm;
• Reproductive system and mammary glands: very rarely - gynecomastia;
• Skin and subcutaneous tissues: often - reactions at the injection site of the solution (with intravenous administration); infrequently - itching, dermatitis, rash, urticaria; rarely - photosensitivity, alopecia; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme;
• Organ of vision: rarely - blurred vision;
• Liver and biliary tract: infrequently - increased activity of liver enzymes; rarely - hepatitis (with or without jaundice); very rarely - liver failure, encephalopathy in patients with liver disease;
• Mental disorders: infrequently - insomnia; rarely - depression, agitation, confusion; very rarely - hallucinations, aggressive behavior;
• Allergic reactions: rarely - hypersensitivity reactions (in the form of fever, angioedema, anaphylactic shock and / or anaphylactic reactions);
• Metabolism: rarely - hyponatremia; very rarely - hypomagnesemia, hypocalcemia associated with severe hypomagnesemia, hypokalemia associated with hypomagnesemia;
• Others: infrequently - peripheral edema; rarely - malaise, sweating.

In critically ill patients with intravenous administration of Nexium, especially when using high doses, irreversible visual impairment may develop (a causal relationship with therapy has not been established).

special instructions

When conducting long-term therapy (especially longer than 12 months), patients should undergo regular medical examinations.

With the development of any alarming signs (vomiting with blood, repeated vomiting, dysphagia, significant sudden weight loss), as well as with a stomach ulcer (or if it is suspected), the presence of malignant neoplasms should be excluded, since Nexium therapy is due to the smoothing of symptoms may delay diagnosis.

When conducting combined treatment for Helicobacter pylori, it is necessary to take into account the possibility of drug interactions of all drugs used.

If there is a high risk of developing osteoporosis or fractures, careful monitoring is necessary for the condition of patients.

During the use of Nexium, care must be taken when driving vehicles, since dizziness, blurred vision and drowsiness may develop during therapy.

drug interaction

With the joint appointment of Nexium with some drugs, the following effects may develop:

• Digoxin: strengthening its absorption;
• Rifampicin, preparations of St. John's wort: a decrease in the concentration of esomeprazole in the blood plasma;
• Itraconazole, ketoconazole, erlotinib: decrease in their absorption;
• Saquinavir, methotrexate, tacrolimus: an increase in their serum concentration;
• Antiretroviral drugs (nelfinavir, atazanavir): a decrease in their serum concentration (simultaneous use is not recommended);
• Clomipramine, citalopram, diazepam, phenytoin, imipramine and other drugs in the metabolism of which the CYP2C19 isoenzyme is involved: an increase in their plasma concentration;
• Phenytoin: increase in its residual concentration in patients with epilepsy.

Terms and conditions of storage

Keep out of the reach of children.

Best before date:

• Granules and pellets for the preparation of a suspension for oral administration: 3 years at a storage temperature of up to 25 ° C;
• Tablets: 3 years when stored at 30°C;
• Lyophilizate for the preparation of an injection solution: 2 years at a storage temperature of up to 30 ° C in a place protected from light. A vial with the drug under room lighting without carton packaging can be stored up to 24 hours.

spravka03.net

Nexium application (instruction)

Tablets Nexium instruction

Instructions for the drug Nexium are enclosed in each package with tablets and contain all the necessary information about it. Here is information about the composition of the tablets, terms and conditions of storage. Pharmacological and pharmacokinetic data are intended to increase the patient's knowledge of the effect of this drug. Indications for use are described in detail in the accompanying sheet and recommendations are given for its use with a dosing regimen.

It also contains instructions and warning instructions about the contraindications of Nexium tablets, side effects from their treatment and cases of overdose. Descriptions of drug interactions of the drug with other drugs and recommendations for use by various categories of patients are given.

Form, composition, packaging

Nexium 20 mg is produced in the form of tablets, which are coated with an oblong biconvex shell. The color is light pink. Both sides of the tablet are engraved with "20mG" on one side and "A/EN" on the other. The kink of the tablet is white interspersed with yellow.

The active substance of the drug is esomeprazole magnesium trihydrate in an amount that corresponds to a concentration of esomeprazole 20 milligrams. As auxiliary substances, glyceryl monostearate, hyprolose, hypromellose, iron oxide red dye (E172), iron oxide yellow dye (E172), magnesium stearate, copolymer of methacrylic and ethacrylic acid taken one to one, microcrystalline cellulose, paraffin, macrogol, polysorbate 80 , crospovidone, sodium stearyl fumarate, sucrose spherical granules, titanium dioxide (E171), talc, triethyl citrate in the required proportions.

In pharmacies, the drug comes in packs of cardboard, which are equipped with the control of the first opening. It is possible to purchase a package with the drug, where four, two or one aluminum blister is placed with the number of tablets of 7 pieces.

The drug is released only on prescription.

Nexium 40 mg is produced in the form of tablets, which are coated with an oblong biconvex shell. Pink colour. Both sides of the tablet are engraved with "40mG" on one side and "A/EI" on the other. The kink of the tablet is white interspersed with yellow.

The active substance of the drug is esomeprazole magnesium trihydrate in an amount that corresponds to a concentration of esomeprazole 40 milligrams. Hyprolose, iron oxide red dye (E172), iron oxide yellow dye (E172), glyceryl monostearate, magnesium stearate, copolymer of methacrylic and ethacrylic acid taken one to one, triethyl citrate, microcrystalline cellulose, talc, hypromellose, paraffin, macrogol, crospovidone, sodium stearyl fumarate, polysorbate 80, sucrose spherical granules, titanium dioxide (E171) in the required proportions.

On pharmacy shelves, the drug can be seen in cardboard packs that have protection in the form of a first opening control. It is possible to choose a drug package containing one, two or four aluminum blisters with seven tablets each.

The drug is released only on prescription.

Terms and conditions of storage

The drug should be stored in its original packaging for no more than three years. The temperature in the place of storage should not exceed 30 degrees. Children should not have access to it.

Pharmacology

Being an inhibitor of H + - K + - ATPase, the drug is capable of reducing the secretion of hydrochloric acid in the stomach. This is possible due to specific inhibition of the proton pump in parietal cells.

Mechanisms of influence

Being a weak base, esomeprazole accumulates, turning into an active form in the acidic environment of the mucosa and its cells, parietal with secretory tubules. There, the proton pump and the enzyme H + - K + - ATP-ase are inhibited, as a result of which the gastric secretion, both basal and stimulated, is suppressed.

The effect of the drug on the formation of acid in the stomach

The pharmacological effect of taking the drug develops within an hour, regardless of the dose taken. Taking Nexium daily once a day for five days, you can achieve a decrease in the concentration of hydrochloric acid in the contents of the stomach by 90 percent.

Inhibition of hydrochloric acid formation and related therapeutic effects

After a month of treatment with Nexium (40 milligrams), about 78 percent of patients diagnosed with reflux esophagitis recover. As a result of the use of the drug for two months, up to 93 percent of patients are cured.

A two-time use of the drug at a dose of 20 milligrams per day with the addition of a course of treatment with appropriate antibiotics leads to the successful elimination of foci of Helicobacter pylori infection in a week of treatment. If the patient during the course of peptic ulcer complications were not observed, then after this course of treatment he will not need to prescribe antisecretory drugs in order to eliminate the symptoms and heal the ulcer.

Also, Nexium, according to confirmed endoscopic studies, is quite effective in bleeding from peptic ulcers.

Additional effect of acid suppression

When treated with Nexium, as well as with other antisecretory drugs, patients experience an increase in plasma gastrin concentration, which is associated with a decrease in acid formation. This process also affects the increase in the concentration of chromogranin, which in turn can affect the results of those studies that are conducted to detect a neuroendocrine tumor. To avoid errors in diagnosis, you should stop taking these medicines about two weeks before the examination.

In those patients who received esomeprozole preparations for a long time, both in adults and in children, the number of enterochromaffin-like cells may be increased. This phenomenon is associated with the fact that the content of gastrin increases in the plasma. However, it is not clinically significant.

Also, in patients after long-term treatment with antisecretory drugs, the formation of a glandular cyst in the stomach is often observed, which is due to a number of physiological changes in a pronounced suppression of acid formation. However, neoplasms are usually benign and reversible after appropriate treatment.

With treatment with drugs to suppress the formation of acid, there is a risk of infections in the gastrointestinal tract. This is due to the fact that the microflora of the stomach that exists in the normal state with the use of these drugs increases, not excluding the content of pathogens that lead to diseases.

The following should be noted: according to the results of comparative studies, it was found that the therapeutic efficacy of Nexium for the treatment of patients with peptic ulcer of the stomach is more pronounced. The same can be said about the implementation of preventive measures using the drug in relation to gastric and duodenal ulcers.

Pharmacokinetics

absorption and distribution

Since the active substance of the drug Nexium esomeprazole is unstable to acidic environments, in the manufacture of tablets it is wrapped in a shell that is not affected by gastric juice.

After taking the tablet, it is rapidly absorbed from the gastrointestinal tract. The maximum effect can be achieved in no more than two hours. The percentage of absolute bioavailability after taking the drug at a concentration of 40 milligrams once can be more than sixty and increase to almost ninety when taken daily. For a dosage of 20 milligrams of the drug, these figures will correspond to 50 and 68 percent. Almost complete (97%) binding to plasma protein occurs. If Nexium is taken simultaneously with food, the absorption of the active substance will be slowed down and reduced, but this has almost no effect on the effectiveness of the drug.

Metabolic processes and drug excretion

The main metabolites of esomeprazole that can be detected in plasma are its sulfo derivatives. Basically, the metabolism of the active substance occurs with the participation of several isoenzymes.

When taking the drug once a day, daily, its active substance is able to be completely excreted from the plasma. In the period between taking the drug, its accumulation does not occur.

Esomeprazole, in the form of its main metabolites, does not affect the secretion of gastric acid. They are excreted when taking the tablets orally with urine up to 80 percent, and the remaining amount is excreted along with the feces. Invariably, esomeprazole can only be detected in the urine, and then no more than 1 percent.

Pharmacokinetics Nexium. Special clinical cases

It is known that metabolism in the human body occurs at different rates. Therefore, patients are distinguished with slow and fast metabolic processes. Of course, the indicator of achieving the maximum concentration of the drug in plasma will be different for these categories of patients, which, in general, does not affect the dosage of the drug and the methods of its administration.

The metabolism of the active substance Nexium in elderly patients has practically no differences.

Hepatic insufficiency in a patient, which is expressed as mild or moderate severity, can lead to a violation of the metabolism of esomeprazole. When liver failure is severe, this may cause a decrease in the metabolism of the active substance of the drug.

Pharmacokinetics in patients with known renal insufficiency has not been studied. However, it can be assumed that in patients of this category, the metabolism of esomeprazole will remain unchanged. Since the kidneys do not excrete the substance itself, but only its metabolites.

All indicators regarding the intake of the drug at any of its concentrations in adolescents and patients in childhood are no different from those in adults.

Nexium indications for use

Nexium is indicated for use in those patients who suffer from the following diseases:

For gastroesophageal reflux disease:

• For the treatment of reflux esophagitis of an erosive nature;
• For the implementation of long-term maintenance therapy in those patients who have healed reflux esophagitis of the erosive type. Therapy is necessary in order to prevent the occurrence of relapse;
• For symptomatic therapy of gastroesophageal reflux disease.

With peptic ulcer of the duodenum and stomach (as a component of the combined therapy):

• For the treatment of duodenal ulcer associated with Helicobacter pylori;
• To carry out preventive measures to avoid the recurrence of peptic ulcer, which is associated with Helicobacter pylori;
• With long-term therapy that suppresses the formation of acid in those patients who have suffered bleeding from peptic ulcers.

With long-term use of non-steroidal anti-inflammatory drugs:

• In order to heal a stomach ulcer, which was formed with the use of NSAIDs;
• For preventive measures to prevent duodenal and gastric ulcers associated with the use of NSAIDs in those patients who are at risk.

In the presence of Zollinger-Ellison syndrome or other conditions that are characterized by hypersecretion of a pathological nature, for example, idiopathic.

Contraindications

It has a drug and a number of contraindications that should be taken into account when prescribing. So Nexium should not be used for treatment:

• With hereditary fructose intolerance;
• With glucose-galactose malabsorption;
• With insufficiency of sucrase-isomaltase;
• In children under 12 years of age, since there are no accurate data on the safety and efficacy of Nexium for this category of patients;
• In children after 12 years of age, do not use for any other indications, except for gastroesophageal reflux disease;
• When treating drugs with nelfinavir and atazanavir in order to exclude their combined use;
• With increased sensitivity to esomeprazole and other components of the drug.

Nexium requires careful appointment when a patient has severe renal failure.

Nexium instructions for use

The drug is taken orally. Each of the tablets must be swallowed as a whole without destroying the shell. Drink water.

For those patients who find it difficult to swallow a tablet, it can be dissolved in clean non-carbonated drinking water. Do not use other liquids. After the disintegration of the tablet, the contents of the glass should be drunk immediately. Then again fill the glass halfway with water and drink the remaining suspension of the drug.

For those patients who cannot swallow, the drug should be administered by administration through a nasogastric tube.

For adults and children over the age of twelve

Gastroesophageal reflux disease

The appointment of the drug Nexium is carried out in single doses of 40 milligrams per single dose during the day, lasting 1 month. If the symptoms of the disease persist after treatment, an additional monthly course of therapy can be prescribed.

Long-term maintenance therapy for those who have recovered from erosive esophagitis

To avoid possible relapses of the disease, the patient is prescribed a single dose of 20 milligrams of the drug per day.

Symptomatic therapy of gastroesophageal reflux disease without esophagitis

Nexium is prescribed at 20 milligrams for a single dose per day for four weeks. Non-cessation of symptoms requires additional examination of the patient. When the symptoms are eliminated, they switch to taking the drug as needed, when symptoms occur and until they are removed, 1 tablet of 20 milligrams is allowed. However, in this regimen, Nexium should not be taken by those patients who take NVPS and are at risk of developing ulcers in the gastrointestinal tract.

Adults Only

Peptic ulcer of the duodenum and stomach

For treatment, the drug is used as part of combination therapy, where Nexium is prescribed in single doses of 20 milligrams together with amoxicillin at a concentration of 1 gram and clarithromycin 500 milligrams each. Each of the medicines should be taken twice a day for one week.

For long-term acid suppression therapy in patients who have experienced bleeding from a peptic ulcer

Tablets are prescribed 40 milligrams once a day within a month after the treatment with antisecretory drugs is completed by intravenous administration.

For the treatment of ulcers due to long-term use of NSAIDs

20 or 40 milligrams once a day. The course of treatment is a month or a half.

For preventive measures of gastric or duodenal ulcers from taking NVPS

Take Nexium once a day at 20 or 40 milligrams.

In those conditions of the patient that are characterized by hypersecretion of a pathological nature (Zollinger-Ellison syndrome, idiopathic hypersecretion)

It is recommended in the initial dose of 40 milligrams twice a day. Further, the doctor doses the drug, using an individual approach to the patient. The duration of therapy directly depends on the clinical manifestations of the disease.

Kidney dysfunction

There is no need to adjust the dosage, however, if the violations are severe, then the drug should be used carefully.

Violation of the functionality of the liver

When violations are of mild or moderate severity, there is no need to adjust the dose, but in severe violations, the maximum daily dose is considered to be 20 milligrams of the drug and no more.

In old age

The dosing regimen is unchanged.

The use of Nexium for children

The use of Nexium for children is contraindicated until they reach the age of 12 years, since there is no data on how safe and effective the drug is for the child's body.

Nexium during pregnancy

It is not advisable to prescribe Nexium during pregnancy, since there is no reliable data on its use for a woman who is expecting a baby. Also, it is not known whether the drug is excreted in breast milk. Therefore, lactating women should not use the drug.

Instructions for use of the drug by nasogastric tube

• Pour a tablet placed in a syringe with drinking water in an approximate amount of 25 to 50 milliliters and add air in a 5 milliliter volume.
• Shake the syringe well, dissolving the tablet for about two minutes.
• Hold the syringe in your hands with the tip up to prevent clogging.
• While continuing to hold the syringe in this direction, insert its tip into the probe.
• Shake the syringe to turn it over. Tip at the bottom. Quickly inject 5 to 10 milliliters of the drug solution into the tube. Then return the syringe to its original position.
• Repeat the procedure until the syringe is completely released.
• If a precipitate from the drug remains in the syringe, water (25 milliliters) and air (5 milliliters) should be added again and the injection procedure repeated.

Side effects

The drug Nexium has an extensive list of side effects, which must be taken into account when treating with its use.

Skin and subcutaneous tissues

• in the form of dermatitis
• in the form of itching
• in the form of a rash,
• In the form of urticaria;
• in the form of alopecia
• In the form of photosensitivity;
• in the form of erythema multiforme,
• In the form of Stevens-Johnson syndrome,
• In the form of toxic epidermal necrolysis.

Musculoskeletal system

• in the form of arthralgia
• in the form of myalgia;
• in the form of muscle weakness.

nervous system

• in the form of a headache;
• In the form of dizziness
• in the form of paresthesia
• in the form of drowsiness;
• In the form of a violation of taste.

Mental disorders

• in the form of insomnia;
• In the form of depression
• In the form of excitement
• in the form of confusion;
• as hallucinations,
• in the form of aggressive behavior.

Digestive system

• In the form of pain in the abdomen,
• In the form of constipation
• in the form of diarrhea
• in the form of flatulence
• In the form of attacks of nausea and vomiting;
• In the form of dry mouth;
• in the form of stomatitis
• In the form of candidiasis of the gastrointestinal tract;
• In the form of microscopic colitis;

Liver and bile ducts

• In the form of increased activity of liver enzymes;
• In the form of hepatitis;
• as liver failure,
• In the form of encephalopathy in patients with hepatic diseases.

reproductive system

Hematopoietic system

• in the form of leukopenia
• In the form of thrombocytopenia;
• In the form of agranulocytosis,
• In the form of pancytopenia;

Allergy

• Like hay fever
• in the form of angioedema,
• In the form of anaphylactic shock;

Respiratory system

Urinary system

• In the form of interstitial nephritis;

organs of vision

• In the form of blurred vision;

Metabolism

• In the form of hyponatremia;
• In the form of hypomagnesemia,
• In the form of hypocalcemia due to severe hypomagnesemia,
• In the form of hypokalemia due to hypomagnesemia.

Others:

• In the form of peripheral edema;
• In the form of malaise and sweating.

Overdose

Cases of overdose with Nexium were quite rare.

Symptoms of excessive use of the drug in a dose of up to 280 milligrams, there were manifestations of general weakness of the body and side effects from digestion. Taking the drug at a time at once 80 milligrams does not cause any signs of overdose.

To eliminate the consequences of an overdose, symptomatic and supportive treatment should be carried out. There is no specific antidote. Carrying out dialysis will not give the expected effect, since the active substance of the drug has good binding to plasma protein.

Drug Interactions

Since the action of the drug Nexium is based on the suppression of the formation of acid in the stomach, this can significantly affect the pharmacological and pharmacokinetic effects of other drugs when they are used together.

• Decreased absorption of ketoconazole, itraconazole, erlotinib.
• Increased absorption of digoxin.
• Co-administration of Nexium with antiretroviral drugs: atazanovir and nelfinovir is not recommended due to the effect of its active substance on the absorption of these drugs.
• Increased plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin. This is especially important to consider if you take Nexium in the "as needed" mode.
• If Nexium is used at a concentration of 40 mg together with phenytoin in patients with epilepsy, then it is necessary to control the residual concentration of the latter in the patient's plasma both at the beginning of Nexium therapy and canceling it.
• The use of the drug in conjunction with tacrolimus leads to an increase in its concentration in the patient's blood serum.
• The use of methotrexate requires a temporary withdrawal of drugs with esomeprazole, since it significantly increases its concentration.
• The drug Nexium does not contribute to a change in the pharmacokinetic parameters of quinidine and amoxicillin.
• Nexium does not interact with naproxen and rofecoxib.
• The combined use of esomeprazole preparations with clarithromycin and variconazole requires an adjustment in the dose of esomeprazole for those patients who suffer from liver disorders, as well as if the use of the drugs is prolonged.
• Rifampicin and St. John's wort reduce the plasma concentration of esomeprazole preparations.

Preparations with the active substance esomeprazole also interact with other medicines. However, their pharmacological and pharmacokinetic actions are not yet fully understood.

Additional instructions

When a patient has alarming symptoms in the form of significant spontaneous weight loss, repeated vomiting attacks, especially with an admixture of blood, dysphagia or black semi-liquid stools with an unpleasant odor, and a stomach ulcer is diagnosed, before starting treatment with Nexium, an examination should be carried out to exclude the presence of a malignant tumor. Otherwise, the drug can smooth out its symptoms and lead to a delay in the correct diagnosis.

With prolonged use of drugs with a similar active substance, atrophic gastritis has occasionally been noted in patients.

Long-term use of Nexium, especially if it lasts more than a year, requires regular medical supervision.

Taking the drug in the "as needed" mode, patients should be attentive to their condition. Don't forget about drug interactions. The slightest change in symptoms should be reported to the doctor.

When prescribing complex therapy with the participation of esomeprazole preparations, it is necessary to take into account their interaction with other medicinal components, as well as possible contraindications and side effects of each of them.

Nexium tablets contain a certain amount of sucrose, so it is not recommended to prescribe the drug to those patients who have an appropriate intolerance.

According to unconfirmed research data, some association has been established between taking the drug and an increased risk of fractures in patients with osteoporosis. Although the data are not reliable, patients with osteoporosis during treatment should be kept under observation in a hospital setting.

Due to the occurrence of states of drowsiness, loss of clarity of vision and dizziness during treatment, you should refrain from driving vehicles and working with mechanisms.

Nexium analogues

Analogues of the drug Nexium are preparations with the same active substance esomeprazole, which are also produced in the form of enteric-coated tablets. They are called Esomeprazole and Neo-Zext. These medications can successfully replace Nexium during treatment.

Nexium price

The cost of the drug is quite high and depends on the number of tablets in the package and the concentration of its active substance.

Nexium 20 mg price

The price of Nexium 20 mg is 2692 rubles per pack of tablets, where there are 28 pieces. A package with fourteen tablets will cost the patient 1413 rubles.

Nexium 40 mg price

The price of the drug Nexium 40 mg per package, where 14 tablets are invested, is 1400 rubles, and the corresponding pack inside which 28 pieces of the drug will cost 3395 rubles.

Nexium reviews

There are not so many reviews about Nexium, however, almost all of them are in a positive way. People like the effectiveness of the drug, but its high cost and a large list of side effects prevent many from using pills for treatment. There are also such patients who purchased the medication, despite its cost and notes its uselessness for themselves, but there are not many of them, mainly those who underwent course treatment with the drug were satisfied with its therapeutic effect.

Galina: I can evaluate Nexium from the category of expensive medicines as a highly effective medicine, however, based on my own experience, I do not recommend its long-term use. Course application, I think is more than enough, and you should not delay the treatment further. Further, oddly enough, it can get worse. Personally, having problems with my stomach, like many others, for reliability, I decided to take a medicine that helps so well for a longer time, and the pills still remained after the end of the course. However, everything is fine while you drink them, as soon as you stop, everything starts to hurt again and a whole bunch of side effects appear. In general, the withdrawal of such treatment is effective, but should be carried out in moderation.

Khanuma: My husband had stomach problems for a long time, and you can't lure him to the hospital. Well, I also decided to check my stomach and at the same time persuade him to go, how much you can suffer. It turned out he had reflux, and the doctor prescribed him several drugs, including Nexium. The drug, I must say, is not cheap, but health is more expensive, therefore, having bought everything strictly according to the prescription, we began treatment. There were fourteen large tablets in the pack, which are not so easy to swallow. After my husband drank one blister, his pains noticeably eased, and he even began to eat with pleasure. And recently, because of the pain, he became very irritable at the table. However, at the next examination, the doctor said that the medicine would have to be bought in addition. Expensive, what can I say. But seeing its effectiveness, let's go to the pharmacy unconditionally. Of course, I can recommend the drug to everyone in need, it helps perfectly, but without a doctor's prescription, you probably shouldn't carry out treatment. Take better care of your stomach.

Julia: No one will argue that today it is very difficult to stay within the framework of proper nutrition, when there are so many temptations around. However, everyone knowing the price of preservatives, food additives and other components of beautiful food packaging that are not useful for the stomach, not to mention fast food, still consumes all this every day, hoping that digestive problems and even worse gastrointestinal diseases will bypass him. And I was no exception. Having a higher medical education, and perfectly understanding all this, I still like to eat unhealthy food. As a result, gastritis and all its charms. However, I suffered so much until I discovered Nexium for myself - a miracle drug that is literally effective. Its only drawback is the cost, which is quite impressive, but the result is worth it. One pill saves me from pain and brings me back to life within half an hour. Another advantage for me in this preparation is the form of its release. Because I can't drink drugs that taste on my tongue, I immediately begin to vomit. I also endure the injections with difficulty, because for a long time I suffer from the pain of a certain place after them. And Nexium tablets are a godsend for me in this regard. You can’t chew them, too, until you swallow, there is no taste either, because they are in the shell. In a word, this medicine suits me in all respects, I have already come to terms with the cost. Thus, I want to summarize and say that the drug is very effective in the presence of problems with the digestive tract. I have been using it for more than five years when necessary, and it has never let me down. However, in recommending a remedy, I do not encourage anyone to self-medicate. Before using it, I advise you to consult a doctor. I did the same when I decided to try it for the first time.

Victor: Having a whole range of problems with the digestive tract, he sought medical help and, having passed the necessary examination, received a doctor's prescription for treatment. Having suffered enough with my sores, I decided to strictly follow the doctor’s prescriptions and bought everything at the pharmacy according to the prescription, although it didn’t cost me cheap. Among the prescriptions was the drug Nexium, which I needed as many as three packs for treatment, when even one is very expensive. But as I already said, I decided to buy everything for a full course of treatment and approach it with all responsibility. To my great regret and surprise, Nexium did not help me at all. Although I took his full course and fulfilled all the prescriptions of the attending physician. Complete disappointment. It's a shame not even for the high costs of such an imaginary treatment, but simply for the lost time and the problem that has not gone away. Therefore, I want to sincerely wish all my fellow sufferers, when you are prescribed an expensive drug, do not take it in full, but take one package for a test and see what effect it will have on you. Perhaps the drug Nexium is really very effective, as many write about it, but for some reason its effect did not manifest itself in me. Maybe he just doesn't suit me. After all, each person's body is different. Be healthy.

Yana: My acquaintance with the drug Nexium began after a visit to a doctor who, after I applied with terrible pain in the abdomen, first prescribed me an examination and, based on its results, treatment with these pills. He somehow kept silent about the cost of the drug. Arriving at the pharmacy, I went home with nothing, because I didn’t even have money for one package of the drug with me. At home, I looked online for reviews about Nexium and decided, regardless of the cost, to try to get treated, because the reviews inspired confidence. I bought the pills the next day and started treatment. From the very first day of taking it, I began to suffer from headaches and dizziness, which are absolutely not characteristic of me. It turned out that these were the side effects of the pills. Since the treatment had just begun, I decided to be patient and continue it. However, after drinking the whole package, I did not notice much improvement in the condition in the gastrointestinal tract, and I began to get used to the headache in two weeks of taking the drug. Another doctor's office. New Nexium appointment for another two weeks. She did not continue such treatment, deciding to look for an alternative. When I find something worthwhile, I will write a review again. In the meantime, I would like to advise everyone who needs help in treating diseases, use only effective therapy, and if it is clear that it does not suit you, it is better to replace it, doctors can also be wrong.

Lyubov: Having problems with the stomach, she practiced the experience of treatment on the recommendation of a doctor with Nexium. After drinking a dozen tablets for his intended purpose, I then admit I did not understand why I needed it. There were four tablets left, and I put them in the first-aid kit, they will suddenly come in handy. For a while, I didn’t even remember the stomach, but the drug helped, until one day I started having terrible heartburn. Having tried all the known remedies for her, in the form of soda and milk, she suddenly remembered Nexium tablets. What was my surprise when, in a matter of minutes, the unpleasant burning sensation disappeared, and the heartburn did not recur. Now I use the drug as needed, when heartburn sticks. It helps 100% and the pills have never failed. By the way, when she began to save herself from heartburn with the help of Nexium, she visits me much less often. I recommend to everyone who also suffers from this trouble, buy the drug - you will not regret it. The pills are expensive, but last a long time. I even sometimes take half a tablet, and it is enough. All health and excellent well-being.

Barbara: Periodically suffering from pain in the stomach, I was not particularly worried about this. I take a pill and after sitting on a sparing diet for several days, I felt that everything had returned to normal. However, as they say, for the time being. And so it turned out for me. Once my stomach was so seized that it was already before the diet, I went straight to the doctor. After a series of examinations, it seems that nothing particularly terrible was revealed, but a course of treatment was nevertheless prescribed. When I bought the medicine for treatment by prescription, I was unpleasantly shocked. One of the prescription drugs was very expensive. But I decided to heal. And although the family budget suffered a little during my treatment, the whole family unanimously approved the purchase of the medicine, which, by the way, turned out to be very effective and eliminated my pain literally at the beginning of the intake. However, following the doctor's instructions, I recovered and am very pleased with the effect. More than a year has passed, and the pain has never shown itself again. I recommend everyone to follow the doctor's prescriptions and not abandon the treatment halfway at the first relief. And it is better to take care of your health and not get sick at all.

Aleksey: I have been suffering from a stomach ulcer for more than a year, and periodically undergo treatment. Until recently, I did not know about Nexium, but then I received his appointment from my doctor. My doctor has been guiding me for a long time and knows my problems. They tried to treat my sore with various drugs and even folk remedies from which, of course, the effect was, but short-lived. But Nexium gave me more long-term relief. When the problem resumes, I immediately begin to take it and you can live on even without depriving yourself of your favorite food. As opposed to what it was before. I can’t even say what I suffered more from pain or from the prohibition of certain foods. Although, of course, at first there were doubts whether to buy it or not - it was too expensive. However, now I firmly believe and recommend it to everyone - an excellent drug for stomach problems. By the way, the instructions for the pills list a lot of side effects, the doctor warned me about them, as well as about the cost of the drug, but none of them touched me. Although, of course, you should pay attention to them, and discuss with your doctor. Treat yourself to health.

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Name:

Nexium (Nexium)

Pharmachologic effect:

Nexium (esomeprazole) is a specific inhibitor of the proton pump of the parietal cells of the gastric mucosa. It is the S-isomer form of omeprazole. It accumulates and transforms into an active state in the secretory tubules, where it suppresses the proton pump (enzyme H + K + -ATPase), thereby developing inhibition of the secretion of hydrochloric acid.

The drug begins to act within 60 minutes after taking 20-40 mg of esomeprazole. Repeated use of 20 mg of esomeprazole every other day 1 time per day is accompanied by a decrease in gastric secretion due to the action of pentagastrin by 90% on about the 5th day of administration.

At a dose of 40 mg, it is effective for the treatment of reflux esophagitis. It is used for the treatment of ulcerative defects of the gastric and duodenal mucosa, in combination with a suitable antibiotic, it allows to achieve the best effect of Helicobacter pylori eradication (90% of cases). As a rule, in the complex treatment of peptic ulcer after the end of antibiotics, there is no need to continue antisecretory monotherapy.

Clinical studies have shown that when taking the drug, the content of gastrin in the blood increases in response to a decrease in the production of hydrochloric acid. An increase in the number of endocrine cells that produce histamine occurs due to an increase in the concentration of gastrin in the blood. In some cases, an increase in the incidence of granular cysts of the gastric mucosa was observed with prolonged use of antisecretory drugs. This phenomenon is regarded as physiological in response to the inhibition of hydrochloric acid production. Cysts are always benign and transient (they disappear after the end of the course of treatment).

Omeprazole is effective in preventing the formation of peptic ulcers with concomitant therapy with non-steroidal anti-inflammatory drugs (even cyclooxygenase inhibitors - 2 selective groups).

Nexium is an acid-dependent drug, it is used in the form of coated granules, inside. Esomeprazole is rapidly absorbed, Cmax is reached in blood plasma approximately 60-120 minutes after oral administration. Bioavailability after taking a single dose of 40 mg - 64%, increases to 90% in case of repeated administration. At a dose of 20 mg, the absolute bioavailability is 50%, 68%, respectively.

Plasma proteins bind 97% of the active substance. With the simultaneous administration of esomeprazole and food, the antisecretory effect does not change, but absorption may be slowed down.

The biometabolism of most of esomeprazole occurs with the participation of the CYP 2C19 enzyme, the rest - with the enzyme isomer: CYP 3A4, all reactions occur with the participation of cytochrome P450. The elimination half-life is approximately 70 minutes after a second dose of esomeprazole every other day. Eliminated from the body by the kidneys entirely in the interval between taking the drug, does not accumulate in the body when taken 1 time per day. A smaller part of esomeprazole is excreted in the feces. Metabolites of the drug do not affect the secretion of hydrochloric acid. Less than 1% of esomeprazole is eliminated unchanged by the kidneys. The metabolism of esomeprazole does not change in the case of the patient's advanced age (71-80 years). Women have a higher AUC value than men (by 30%), this does not affect the choice of dose for male and female patients. A special group of patients are weak metabolizers - people whose metabolism occurs due only to the influence of CYP 3A4. In weak metabolizers, the AUC figures (average per day) are 100% higher than in those who have pronounced activity and isomer (extensive metabolizers) - enzyme CYP 2C19. This does not affect the choice of dosage for either group of people. Esomeprazole metabolism disorders in patients with hepatic insufficiency have not been identified. The rate of biotransformation decreases only with severe disorders, which leads to a 2-fold increase in AUC. Due to this, it is recommended to use a dose of esomeprazole equal to 20 mg per day for such patients.

Studies have not been conducted to identify the features of the metabolism of esomeprazole in patients with renal insufficiency. Since it is not the active substance that is eliminated by the kidneys, but metabolites, then biotransformation disorders should not be expected. Studies have been conducted in adolescence - the effect of action and the parameters of the maximum concentration of omeprazole in blood plasma from the age of 12 are the same as in adult patients.

Indications for use:

Therapy for Zollinger-Ellison syndrome,

Reflux esophagitis (both symptomatic therapy and anti-relapse treatment, as well as etiological therapy of the ulcerative form of reflux gastritis),

Eradication of Helicobacter pylori - in complex treatment with antibacterial drugs for peptic ulcer of the stomach and duodenum,

Preventive therapy of peptic ulcers with the use of NSAIDs, treatment of ulcers caused by non-steroidal anti-inflammatory drugs.

Application method:

Nexium is used only for internal use, tablets should be swallowed without chewing, washed down with a small amount of water. If swallowing function is impaired, you can place 1 tablet in water (100 ml, non-carbonated) and drink immediately after dissolving the tablet (or after 30 minutes). Other solutions (tea, milk) should not be used categorically - this can damage the special coated tablets. After the liquid is drunk, you must additionally take 1 glass of water, use the same glass. In extreme cases, with severe violations of the swallowing function, it is necessary to introduce Nexium through a tube (nasogastric). Before administration, the tablet is dissolved in water according to the method already described. Dissolved in water, draw up 5-10 ml of Nexium into a syringe of a size suitable for the probe and inject into the probe.

Treatment of reflux esophagitis

40 mg / day for 4 weeks, if symptoms persist, therapy can be extended for another 4 weeks. As an anti-relapse therapy, it is used at a dose of 20 mg / day. For the relief of symptoms in reflux esophagitis, 20 mg / day is used for 4 weeks, while maintaining signs of the disease, it is necessary to clarify the diagnosis. For follow-up, 20 mg/day or as needed can be used. The use of Nexium "on demand" as a preventive therapy is not recommended for people using NSAIDs with an increased risk of peptic ulcers.

In the complex treatment of peptic ulcer of the stomach and duodenum associated with Helicobacter pylori infection, or as an anti-relapse therapy.

20 mg of esomeprazole in combination with amoxicillin (1000 mg) and clarithromycin (500 mg) 2 r / day for 1 week.

Patients who are prescribed non-steroidal anti-inflammatory drugs for a long time: 20 mg 1 r / day. In the treatment of peptic ulcer caused by NSAIDs, the duration of therapy is 4-8 weeks.

With Zollinger-Ellison syndrome - 40 mg 2 r / day. The duration of treatment and doses are selected individually depending on the clinical situation. The maximum allowable dose for patients with this syndrome is 80-160 mg / day.

In hepatic insufficiency, the maximum allowable dose of esomeprazole is 20 mg / day. Dosage adjustment is not required in patients with renal insufficiency, however, Nexium should be used with caution in severely impaired renal function.

Undesirable phenomena:

Central nervous system and peripheral nervous system: drowsiness, depression, paresthesia, aggressiveness, insomnia, irritability, dizziness, hallucinations (especially in seriously ill patients).

Gastrointestinal tract: candidiasis, stomatitis.

Blood and hematopoietic system: thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.

Liver: hepatitis (with and without jaundice), encephalopathy (in case of severe liver disease in history), liver failure.

Musculoskeletal system: muscle weakness, joint pain.

Skin: photosensitivity, rash, toxic epidermal necrolysis, alopecia.

Other: hypersensitivity reactions (bronchospasm, fever, nephritis, increased sweating), edema, hyponatremia, taste changes.

Contraindications:

Age up to 12 years (there are no clinical studies in this age group),

Hypersensitivity reactions (including to benzimidazoles),

while taking atazanavir.

During pregnancy:

There are very few data on the use of esomeprazole in pregnant women, so the drug is prescribed with caution. In clinical experiments, no embryotoxic and teratogenic effects of Nexium, effects on the birth process and gestation, rates of the postnatal period were detected. While it is not known about the likelihood of penetration of Nexium into breast milk, it is not recommended to prescribe the drug during lactation.

Interaction with other drugs:

If the absorption of other drugs depends on the acidity of the gastric contents, then esomeprazole may increase or decrease the ability to absorb. During therapy with esomeprazole, a decrease in the absorption of itroconazole and ketoconazole is observed. Suppression of the production of CYP 2C19 leads to an increase in the plasma levels of those drugs whose biometabolism occurs with the participation of this enzyme: citalopram, diazepam, clomipramine, phenytoin, imipramine. This usually requires a reduction in the dosage of the latter.

When using esomeprazole, it is necessary to monitor coagulation parameters while using warfarin and esomeprazole.

With the combination of esomeprazole and cisapride, there is an increase of 32% in AUC and an increase in the half-life of cisapride (by 31%), but there are no significant fluctuations in the concentration of cisapride in the blood. In some cases, a significant increase in the QT interval was noted, however, when combined with esomeprazole, no progression of an increase in the interval was found. The combination with atazanavir, ritonavir shows a decrease in the activity of antiviral drugs, even with an increase in their dosage.

Since the active substance of Nexium is metabolized by CYP 3A4 and CYP 2C19 enzymes, the combined use of esomeprazole and clarithromycin, which is an inhibitor of CYP 3A4 enzyme activity, increases the AUC of Nexium. In this case, dosage adjustment of esomeprazole is not required.

The combined use of voriconazole and esomeprazole leads to an increase in the exposure of the latter by more than 2 times (dosage adjustment of Nexium is not required).

Overdose:

There are very few data on cases of esomeprazole overdose. It is known that the use of Nexium at a dose of 80 mg does not cause any pronounced toxic effects. After using the drug at a dose of 280 mg, there is general weakness, signs of a violation of the gastrointestinal tract. There is no specific antidote for esomeprazole. Carrying out hemodialysis is ineffective, since the drug is mostly bound by plasma proteins. In case of overdose symptoms, supportive and symptomatic therapy is carried out.

Release form of the drug:

Tablets of 20, 40 mg, 7 pieces in a blister, in a carton 1, 2 or 4 blisters. The tablets are light pink, biconvex, oblong in shape, on one side engraved "20 mG" (for tablets of 20 mg) or "40 mG" (for tablets of 40 mg), on the other side the fraction "A / EH" is engraved.

Storage conditions:

In a place that is inaccessible to children. Temperature - not higher than 30 ° С.

Compound:

Active ingredient: esomeprazole (as sodium trihydrate).

Auxiliary components: iron dioxide red-brown (E 172), magnesium stearate, glycerol monostearate 40-55, iron oxide yellow (E172), polysorbate 80, macrogol 6000, methacrylic copolymer acid of ethyl acrylate 1: 1, sugar, hydroxypropyl cellulose, sodium stearyl fumarate, triethyl citrate, microcrystalline cellulose, titanium dioxide (E171), hypromellose, talc, crospovidone, synthetic paraffin.

Additionally:

The intake of Nexium helps to mask the signs of a malignant disease of the stomach, so it is necessary to exclude a neoplasm before prescribing esomeprazole (especially in cases of weight loss, dysphagia, bleeding from the intestines - melena or hematemesis, nausea). Those patients who take the drug for more than 1 year should be under the supervision of medical personnel. Patients taking Nexium "on demand" should be informed that if any new symptoms appear, the attending physician should be informed. The drug is not prescribed for intolerance (hereditary) fructose or malabsorption of glucose (galactose), or in cases of lack of isomaltose-sucrose.

Reception of Nexium does not affect the ability to drive vehicles or when working with complex mechanisms.

Articles on this topic:

The inclusion of Nexium in the treatment of peptic ulcer Antisecretory therapy. The choice of the optimal means. Tactics for the treatment of diseases of the esophagus Treatment of NSAIDs - gastropathy The use of the drug Nexium for the treatment of gastrointestinal tract - bleeding All materials on the drug "Nexium"

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Nexium- a drug that is produced in Sweden is a drug that lowers the secretion of the gastric glands, a proton pump inhibitor.
The active substance of this drug is esomeprazole.
Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion by specific inhibition of the proton pump in gastric parietal cells. The S- and R-isomers of omeprazole have similar pharmacodynamic activity.
The mechanism of action of Esomeprazole is a weak base, which passes into the active form in the highly acidic environment of the secretory tubules of the parietal cells of the gastric mucosa and inhibits the proton pump - the enzyme H + / K + - ATPase, while inhibiting both basal and stimulated secretion of hydrochloric acid .
Influence on the secretion of acid in the stomach. The action of esomeprazole develops within 1 hour after oral administration of 20 mg or 40 mg. With daily administration of the drug for 5 days at a dose of 20 mg once a day, the average maximum concentration of hydrochloric acid after stimulation with pentagastrin is reduced by 90% (when measuring the acid concentration 6-7 hours after taking the drug on the 5th day of therapy).

Indications for use

Indications for the use of the drug Nexium are:
Gastroesophageal reflux disease:
- treatment of erosive reflux esophagitis
- long-term maintenance treatment after healing of erosive reflux esophagitis to prevent recurrence
- symptomatic treatment of gastroesophageal reflux disease

Peptic ulcer of the stomach and duodenum
As part of combination therapy:
- treatment of duodenal ulcer associated with Helicobacter pylori
- prevention of recurrence of peptic ulcer associated with Helicobacter pylori
Long-term acid-suppressing therapy in patients who have had bleeding from a peptic ulcer (after intravenous use of drugs that reduce the secretion of the gastric glands to prevent relapse).

Patients taking NSAIDs for a long time:
- healing of gastric ulcers associated with the use of NSAIDs
- prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk
Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of the gastric glands, including idiopathic hypersecretion.

Mode of application

Tablets Nexium are taken orally, tablets should be swallowed without chewing, washed down with a small amount of water. If swallowing function is impaired, you can place 1 tablet in water (100 ml, non-carbonated) and drink immediately after dissolving the tablet (or after 30 minutes). Other solutions (tea, milk) should not be used categorically - this can damage the special coated tablets. After the liquid is drunk, you must additionally take 1 glass of water, use the same glass. In extreme cases, with severe violations of the swallowing function, it is necessary to introduce Nexium through a tube (nasogastric). Before administration, the tablet is dissolved in water according to the method already described. Dissolved in water, draw up 5-10 ml of Nexium into a syringe of a size suitable for the probe and inject into the probe.

Treatment of reflux esophagitis
40 mg / day for 4 weeks, if symptoms persist, therapy can be extended for another 4 weeks. As an anti-relapse therapy, it is used at a dose of 20 mg / day. For the relief of symptoms in reflux esophagitis, 20 mg / day is used for 4 weeks, while maintaining signs of the disease, it is necessary to clarify the diagnosis. For follow-up, 20 mg/day or as needed can be used. The use of Nexium "on demand" as a preventive therapy is not recommended for people using NSAIDs with an increased risk of peptic ulcers.

In complex treatment peptic ulcer of the stomach and duodenum associated with Helicobacter pylori infection, or as an anti-relapse therapy.
20 mg of esomeprazole in combination with amoxicillin (1000 mg) and clarithromycin (500 mg) 2 r / day for 1 week.
Patients who are prescribed non-steroidal anti-inflammatory drugs for a long time: 20 mg 1 r / day. In the treatment of peptic ulcer caused by NSAIDs, the duration of therapy is 4-8 weeks.

At Zollinger-Ellison syndrome- 40 mg 2 r / day. The duration of treatment and doses are selected individually depending on the clinical situation. The maximum allowable dose for patients with this syndrome is 80-160 mg / day.

In hepatic insufficiency, the maximum allowable dose of esomeprazole is 20 mg / day. Dosage adjustment is not required in patients with renal insufficiency, however, Nexium should be used with caution in severely impaired renal function.

Side effects

When using tablets Nexium the following side effects may be observed:
Central nervous system and peripheral nervous system: drowsiness, depression, paresthesia, aggressiveness, insomnia, irritability, dizziness, hallucinations (especially in seriously ill patients).
Gastrointestinal tract: candidiasis, stomatitis.
Blood and hematopoietic system: thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.
Liver: hepatitis (with and without jaundice), encephalopathy (in case of severe liver disease in history), liver failure.
Musculoskeletal system: muscle weakness, joint pain.
Skin: photosensitivity, rash, toxic epidermal necrolysis, alopecia.
Other: hypersensitivity reactions (bronchospasm, fever, nephritis, increased sweating), edema, hyponatremia, taste changes.

Contraindications

:
Contraindications to the use of the drug Nexium are: age up to 12 years (there are no clinical studies in this age group); hypersensitivity reactions (including to benzimidazoles); while taking atazanavir.

Pregnancy

:
There are very few data on the use of esomeprazole in pregnant women, so the drug Nexium administered with caution. In clinical experiments, no embryotoxic and teratogenic effects of Nexium, effects on the birth process and gestation, rates of the postnatal period were detected. It is not yet known about the likelihood of penetration of Nexium into breast milk - it is not recommended to prescribe the drug during lactation.

Interaction with other drugs

If the absorption of other drugs depends on the acidity of the gastric contents, then esomeprazole may increase or decrease the ability to absorb. During therapy with esomeprazole, a decrease in the absorption of itroconazole and ketoconazole is observed. Suppression of the production of CYP 2C19 leads to an increase in the plasma levels of those drugs whose biometabolism occurs with the participation of this enzyme: citalopram, diazepam, clomipramine, phenytoin, imipramine. This usually requires a reduction in the dosage of the latter.
When using esomeprazole, it is necessary to monitor coagulation parameters while using warfarin and esomeprazole.
With the combination of esomeprazole and cisapride, there is an increase of 32% in AUC and an increase in the half-life of cisapride (by 31%), but there are no significant fluctuations in the concentration of cisapride in the blood. In some cases, a significant increase in the QT interval was noted, however, when combined with esomeprazole, no progression of an increase in the interval was found. The combination with atazanavir, ritonavir shows a decrease in the activity of antiviral drugs, even with an increase in their dosage.
Since the active substance of Nexium is metabolized by CYP 3A4 and CYP 2C19 enzymes, the combined use of esomeprazole and clarithromycin, which is an inhibitor of CYP 3A4 enzyme activity, increases the AUC of Nexium. In this case, dosage adjustment of esomeprazole is not required.
The combined use of voriconazole and esomeprazole leads to an increase in the exposure of the latter by more than 2 times (dosage adjustment of Nexium is not required).

Overdose

:
Very few data on cases of drug overdose Nexium. It is known that the use of Nexium at a dose of 80 mg does not cause any pronounced toxic effects. After using the drug at a dose of 280 mg, there is general weakness, signs of a violation of the gastrointestinal tract. There is no specific antidote for esomeprazole. Carrying out hemodialysis is ineffective, since the drug is mostly bound by plasma proteins. In case of overdose symptoms, supportive and symptomatic therapy is carried out.

Storage conditions

At a temperature not exceeding 30? C, in the original packaging, out of the reach of children.

Release form

Tablets of 20; 40 mg, 7 pieces in a blister, in a carton 1; 2 or 4 blisters. The tablets are light pink, biconvex, oblong in shape, on one side engraved "20 mG" (for tablets of 20 mg) or "40 mG" (for tablets of 40 mg), on the other side the fraction "A / EH" is engraved.

Compound

:
1 tablet Nexium 20 mg contains: active substance: 22.30 mg of esomeprazole magnesium trihydrate, which corresponds to 20 mg of esomeprazole.
Excipients: glyceryl monostearate 40-55 1.70 mg, hyprolose 8.10 mg, hypromellose 17.00 mg, iron dye red oxide (E172) 0.06 mg, iron dye yellow oxide (E172) 0.02 mg, magnesium stearate 1.20 mg, methacrylic and ethacrylic acids copolymer (1:1) 35.00 mg, microcrystalline cellulose 273.00 mg, paraffin 0.20 mg, macrogol 3.00 mg, polysorbate 80 0.62 mg, crospovidone 5, 70 mg, sodium stearyl fumarate 0.57 mg, sucrose spherical granules (sugar, spherical granules) (size 0.250-0.355 mm) 28.00 mg, titanium dioxide (E171) 2.90 mg, talc 14.00 mg, triethyl citrate 10, 00 mg.

1tablet Nexium 40 mg contains: active substance: 44.50 mg of esomeprazole magnesium trihydrate, which corresponds to 40 mg of esomeprazole.
Excipients: glyceryl monostearate 40-55 2.30 mg, hyprolose 11.00 mg, hypromellose 26.00 mg, iron dye red oxide (E172) 0.45 mg, magnesium stearate 1.70 mg, methacrylic and ethacrylic acid copolymer ( 1:1) 46.00
mg, microcrystalline cellulose 389.00 mg, paraffin 0.30 mg, macrogol 4.30 mg, polysorbate 80 1.10 mg, crospovidone 8.10 mg, sodium stearyl fumarate 0.81 mg, sucrose spherical granules (sugar, spherical granules) (size 0.250-0.355 mm) 30.00 mg, titanium dioxide (E171) 3.80 mg, talc 20.00 mg, triethyl citrate 14.00 mg.

main parameters

Name:

NEXIUM TABLETS