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Vilprafen solutab suspension instructions for use. Vilprafen for children with diseases of bacterial etiology

Registration number:

Tradename: VILPRAFEN SOLUTAB

International nonproprietary name (INN): Josamycin

Dosage form: dispersible tablets

Composition per 1 tablet

Active substance:
Josamycin - 1000 mg (which is equivalent to josamycin propionate) - 1067.66 mg.

Excipients:
Microcrystalline cellulose - 564.53 mg, hyprolose - 199.82 mg, docusate sodium - 10.02 mg, aspartame - 10.09 mg, colloidal silicon dioxide - 2.91 mg, strawberry flavor - 50.05 mg, magnesium stearate - 34.92 mg.

Description:

White or white with a yellowish tinge, oblong-shaped tablets, sweet, with a strawberry odor. With the inscription "JOSA" and a notch on one side of the tablet and the inscription "1000" on the other.

Pharmacotherapeutic group: antibiotic, macrolide.

ATC code: J01FA07

Pharmacological properties

Pharmacodynamics.
The drug is used to treat bacterial infections; bacteriostatic activity of josamycin, like other macrolides, is due to inhibition of bacterial protein synthesis. When creating high concentrations in the focus of inflammation, it has a bactericidal effect.
Josamycin is highly active against intracellular microorganisms (Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila); gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphteriae), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis), as well as against some anaerobic bacteria (Peptococcus, Peptostreptococcus, Clostridium perfringium). Slightly affects enterobacteria, therefore, little changes the natural bacterial flora of the gastrointestinal tract. Effective with resistance to erythromycin. Resistance to josamycin develops less frequently than to other macrolide antibiotics.

Pharmacokinetics.
After oral administration, josamycin is rapidly and completely absorbed from the gastrointestinal tract, food intake does not affect bioavailability. The maximum concentration of josamycin in serum is reached 1-2 hours after administration. About 15% of josamycin binds to plasma proteins. Particularly high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and lacrimal fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Passes the placental barrier, is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and excreted primarily in the bile. Urinary excretion of the drug is less than 20%.

Indications for use

Acute and chronic infections caused by susceptible organisms, such as:
Infections of the upper respiratory tract and ENT organs:
Angina, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), as well as scarlet fever in case of hypersensitivity to penicillin.
Lower respiratory tract infections:
Acute bronchitis, exacerbation of chronic bronchitis, pneumonia (including those caused by atypical pathogens), whooping cough, psittacosis.
dental infections
Gingivitis and periodontal disease. Infections in ophthalmology Blepharitis, dacryocystitis.
Skin and soft tissue infections
Pyoderma, furunculosis, anthrax, erysipelas (with increased sensitivity to penicillin), acne, lymphangitis, lymphadenitis, lymphogranuloma venereum.
Urinary tract infections
Prostatitis, urethritis, gonorrhea, syphilis (with hypersensitivity to penicillin), chlamydia, mycoplasma (including ureaplasma) and mixed infections.

Contraindications

hypersensitivity to macrolide antibiotics severe liver dysfunction

Pregnancy and lactation

It is allowed to use during pregnancy and during breastfeeding after a medical assessment of the benefits / risks. The WHO European Office recommends josamycin as the drug of choice for the treatment of chlamydial infection in pregnant women.

Dosage and administration

The recommended daily dosage for adults and adolescents over 14 years of age is 1 to 2 g of josamycin. The daily dose should be divided into 2-3 doses. If necessary, the dose can be increased to 3 g per day.
Children aged 1 year have an average body weight of 10 kg.
The daily dosage for children weighing at least 10 kg is prescribed based on the calculation of 40-50 mg / kg of body weight daily, divided into 2-3 doses: for children weighing 10-20 kg, the drug is prescribed at 250-500 mg ( 1/4-1/2 tablets dissolved in water) 2 times a day, for children weighing 20-40 kg, the drug is prescribed 500 mg-1000 mg (1/2 tablet -1 tablet dissolved in water) 2 times per day, more than 40 kg - 1000 mg (1 tablet) 2 times a day.
Usually the duration of treatment is determined by the doctor. In accordance with the recommendations of the World Health Organization on the use of antibiotics, the duration of treatment for streptococcal infections should be at least 10 days.

In anti-Helicobacter therapy regimens, josamycin is prescribed at a dose of 1 g 2 times a day for 7-14 days in combination with other drugs in their standard dosages (famotidine 40 mg / day or ranitidine 150 mg 2 r / day + josamycin 1 g 2 r / day day + metronidazole 500 mg twice daily; omeprazole 20 mg (or lansoprazole 30 mg or pantoprazole 40 mg or esomeprazole 20 mg or rabeprazole 20 mg) twice daily + amoxicillin 1 g twice daily + josamycin 1 g 2 r/day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) bid + amoxicillin 1 g bid + josamycin 1 g bid + bismuth tripotassium dicitrate 240 mg 2 r/day: famotidine 40 mg/day + furazolidone 100 mg 2 r/day + josamycin 1 g 2 r/day + bismuth tripotassium dicitrate 240 mg 2 r/day).

In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: Amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + tripotassium bismuth d and citrate 240 mg 2 r / day.

In the case of acne vulgaris and globulus, it is recommended to prescribe josamycin at a dose of 500 mg twice a day for the first 2-4 weeks, then 500 mg of josamycin once a day as maintenance treatment for 8 weeks.

Dispersible tablets Vilprafen Solutab can be taken in various ways: the tablet can be swallowed whole with water or previously, before taking, dissolved in water. Tablets should be dissolved in at least 20 ml of water. Before taking, mix the resulting suspension thoroughly.

Influence on the ability to drive vehicles and work with mechanisms
There was no effect of the drug on the ability to drive vehicles and work with mechanisms.

Side effect

From the gastrointestinal tract
Rarely - loss of appetite, nausea, heartburn, vomiting, dysbacteriosis and diarrhea. In the case of persistent severe diarrhea, one should keep in mind the possibility of developing life-threatening pseudomembranous colitis against the background of antibiotics.
Hypersensitivity reactions:
In extremely rare cases, allergic skin reactions (eg, urticaria) are possible.
From the side of the liver and biliary tract
In some cases, a transient increase in the activity of liver enzymes in the blood plasma was observed, in rare cases accompanied by a violation of the outflow of bile and jaundice.
From the side of the hearing aid
In rare cases, dose-dependent transient hearing loss has been reported.
Others: very rarely - candidiasis.

Overdose and other mistakes when taking

To date, there are no data on specific symptoms of poisoning. In case of an overdose, the occurrence of the symptoms described in the "Side effects" section should be expected, especially from the gastrointestinal tract. If one dose is missed, you must immediately take a dose of the drug. However, if it is time for the next dose, do not take the "forgotten" dose, but return to the usual treatment regimen. Do not double the dose. Interruption in treatment or premature discontinuation of the drug reduces the likelihood of treatment success.

Interaction with other drugs

Vilprafen Solutab / other antibiotics
Since bacteriostatic antibiotics may reduce the bactericidal effect of other antibiotics such as penicillins and cephalosporins, co-administration of josamycin with these types of antibiotics should be avoided. Josamycin should not be co-administered with lincomycin, as there may be a mutual decrease in their effectiveness.
Vilprafen Solutab / xanthines
Some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical and experimental studies indicate that josamycin has less effect on theophylline release than other macrolide antibiotics.
Vilprafen Solutab / antihistamines
After the joint appointment of josamycin and antihistamines containing terfenadine or astemizole, there may be a slowdown in the excretion of terfenadine and astemizole, which in turn can lead to the development of life-threatening cardiac arrhythmias.
Vilprafen Solutab / ergot alkaloids
There are individual reports of increased vasoconstriction after the co-administration of ergot alkaloids and macrolide antibiotics. There has been one case of ergotamine intolerance in a patient while taking josamycin. Therefore, the concomitant use of josamycin and ergotamine should be accompanied by appropriate monitoring of patients.
Vilprafen Solutab / cyclosporine
Co-administration of josamycin and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and the creation of a nephrotoxic concentration of cyclosporine in the blood. Plasma concentrations of cyclosporine should be regularly monitored.
Vilprafen Solutab / digoxin
With the joint appointment of josamycin and digoxin, an increase in the level of the latter in the blood plasma is possible.
Vilprafen Solutab / hormonal contraceptives
In rare cases, the contraceptive effect of hormonal contraceptives may be insufficient during treatment with macrolides. In this case, it is recommended to additionally use non-hormonal contraceptives.

special instructions

In patients with renal insufficiency, treatment should be based on the results of appropriate laboratory tests.
Consideration should be given to the possibility of cross-resistance to various macrolide antibiotics (eg, organisms resistant to treatment with chemically related antibiotics may also be resistant to josamycin).

Release form: 1000 mg dispersible tablets.
Standard Packing:
5 or 6 dispersible tablets in a blister made of PVC film and aluminum foil. 2 blisters with instructions for use in a cardboard box.

Best before date: 2 years

Vilprafen Solutab should not be used after the expiry date which is stated on the package.

Storage conditions

List B.
Store in a dry, dark place at a temperature not exceeding 25°C.
Keep the medicine out of the reach of children!

Terms of dispensing from pharmacies

Released by prescription

Registration applicant (registration holder)

Astsllas Pharma Europe B.V., Elizabethof 19, 2353 EB Leiderdorp,
Netherlands / Astellas Pharma Europe B.V.,
Elisabethhof 19.2353 EW Leiderdorp, The Netherlands.

Manufacturer:
Montefarmaco S.
Italy/Montefarmaco S.p.A.
Via Galilei, n.7, 20016 Pero (MI), Italy

Packer (primary packaging)
Montefarmaco S.p.A., Italy

Packer (secondary/tertiary packaging)
Montefarmaco S.p.A., Italy or Temmler Italia S.rL., Italy
Issuing quality control
Temmler Italia S.r.L., Italy
Subject to packaging at ORTAT CJSC
Manufacturer Montefarmaco S.
Italy/Montefarmaco S.p.A. Via Galilei, n.7,20016 Pero (MG), Italia

Packer and release control
ZAO ORTAT, Russia
157092, Kostroma region, Susaninsky
district, s. Northern, m-n Kharitonovo.

Claims should be sent to the Moscow Representative Office of Astellas
Pharma Yuroy B.V. by the address:
109147 Moscow, Marksistskaya st. 16,
"Mosalarko Plaza-1" business center,

Vilprafen Solutab

International non-proprietary name

Josamycin

Dosage form

Dispersible tablets 1000 mg

Compound

One tablet contains

active substance - josamycin 1000.0 mg, equivalent to josamycin propionate 1067. 66 mg,

Excipients: microcrystalline cellulose, hyprolose (L.M.), sodium docusate, aspartame, colloidal anhydrous silica, strawberry flavor 052311 AP 0551, magnesium stearate.

Description

White or white with a yellowish tint, oblong, sweet, strawberry-flavoured tablets, marked “IOSA” with a notch on one side and the words “1000” on the other.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Josamycin.

ATX code J01FA07

Pharmacological properties

Pharmacokinetics

After oral administration, josamycin is rapidly and completely absorbed from the gastrointestinal tract, food intake does not affect bioavailability. The maximum concentration of josamycin in serum is reached 1-2 hours after administration. About 15% of josamycin binds to plasma proteins. Particularly high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and lacrimal fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Passes the placental barrier, is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and excreted mainly in the bile. Excretion of the drug in the urine is less than 20%.

Pharmacodynamics

Vilprafen Solutab is used to treat bacterial infections; its bacteriostatic activity is due to inhibition of bacterial protein synthesis. When creating high concentrations in the focus of inflammation, it has a bactericidal effect.

The drug is highly active against intracellular microorganisms (Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila); gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphteriae), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis), as well as against some anaerobic bacteria (Peptococcus, Peptostreptococcus, Clostridium perfringium). Slightly affects enterobacteria, therefore, little changes the natural bacterial flora of the gastrointestinal tract. Effective with resistance to erythromycin. Resistance to Vilprafen Solutab develops less frequently than to other macrolide antibiotics.

Indications for use

Acute and chronic infections caused by susceptible microorganisms:

Tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis

Diphtheria (in addition to treatment with diphtheria antitoxic serum)

Scarlet fever, in case of hypersensitivity to penicillin

Acute bronchitis, exacerbation of chronic bronchitis

Pneumonia (including those caused by atypical pathogens)

Psittacosis

Gingivitis and periodontal disease

- blepharitis, dacryocystitis

Pyoderma, furunculosis, anthrax, erysipelas (with increased sensitivity to penicillin)

Acne, lymphangitis, lymphadenitis, inguinal lymphogranuloma

Prostatitis, urethritis, gonorrhea, syphilis (with increased sensitivity to penicillin)

Chlamydia, mycoplasma (including ureaplasma) and mixed infections

Dosage and administration

Dispersible tablets Vilprafen Solutab can be taken in two different ways: they can be swallowed whole with water or pre-dissolved in water before taking. Tablets should be dissolved in at least 20 ml of water. Before taking, the resulting suspension should be thoroughly mixed.

Recommended daily dose for adults and adolescents aged over 14 years old is from 1 g to 2 g of the drug. If necessary, the dose can be increased to 3 g per day. The daily dose should be divided into 2-3 doses.

Daily dose for children from 5 to 14 years old is prescribed based on the calculation of 40 - 50 mg / kg of body weight daily, divided into 2-3 doses.

Treatment should be continued for more than 48 hours after the cessation of symptoms of the disease and the normalization of body temperature.

Side effects

Adverse reactions are listed according to the frequency of their registration in accordance with the following gradation: very often (≥1/10), often (≥1/100,< 1/10), нечасто (≥1/1000, < 1/100), редко (≥1/10 000 до <1/1000), очень редко

(<1/10 000), не известно (частота не может быть оценена по имеющимся данным).

Bloating, stomatitis, nausea, vomiting, abdominal discomfort and diarrhea, pseudomembranous colitis, decreased appetite

Purpura, bullous dermatitis, erythema, Steven-Johnson syndrome, urticaria and skin reactions, angioedema, toxic epidermal necrolysis, anaphylactic reactions

- hepatic dysfunction and jaundice, usually characterized by, but not limited to, cholestatic reactions associated with mild renal impairment

Contraindications

hypersensitivity to macrolide antibiotics and other components of the drug

severe liver dysfunction

Drug Interactions

Vilprafen Solutab slightly affects the cytochrome P450 system, suppressing metabolism and increasing the plasma concentration of indirect anticoagulants, carbamazipine, valproic acid, disopyramide.

Vilprafen Solutab / other antibiotics

Since bacteriostatic antibiotics can reduce the bactericidal effect of other antibiotics, such as penicillins and cephalosporins, co-administration of the drug with these types of antibiotics should be avoided. It should not be administered together with lincomycin, since a mutual decrease in their effectiveness is possible.

Vilprafen Solutab / xanthines

Some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical and experimental studies indicate that Wilprafen Solutab has less effect on theophylline release than other macrolide antibiotics.

Vilprafen Solutab / antihistamines

After the joint appointment of the drug and drugs containing terfenadine and astemizole, there may be a slowdown in the excretion of terfenadine or astemizole, which in turn can lead to the development of life-threatening cardiac arrhythmias due to prolongation of the QT interval.

Vilprafen Solutab / serotonin 5-HT 4 receptor agonists

Co-administration of the drug Vilprafen Solutab and drugs containing cisapride may slow down the excretion of cisapride, which in turn can lead to the development of life-threatening cardiac arrhythmias due to prolongation of the QT interval.

Vilprafen Solutab / ergot alkaloids

There are individual reports of increased vasoconstriction after the co-administration of ergot alkaloids and macrolide antibiotics. Therefore, the concomitant use of Vilprafen Solutab and ergotamine should be accompanied by appropriate monitoring of patients.

Vilprafen Solutab / cyclosporine

Co-administration of the drug Vilprafen Solutab and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and the creation of a nephrotoxic concentration of cyclosporine in the blood. Plasma concentrations of cyclosporine should be regularly monitored.

Vilprafen Solutab / digoxin

With the joint appointment of Vilprafen Solutab and digoxin, an increase in the level of the latter in the blood plasma is possible.

Vilprafen Solutab / hormonal contraceptives

In rare cases, the contraceptive effect of hormonal contraceptives may be insufficient during treatment with macrolides. In this case, it is recommended to additionally use non-hormonal contraceptives.

Vilprafen Solutab / triazolam

Josamycin may increase the effect of triazolam and cause drowsiness. In case of an overdose of triazolam, it is recommended to temporarily suspend treatment with the drug.

Vilprafen Solutab / Bromocriptine

Josamycin can increase the effect of bromocriptine mesylate and cause drowsiness, dizziness, ataxia. In the case of the use of bromocriptine mesylate, it is recommended to temporarily suspend treatment with Vilprafen Solutab.

Antacids slightly reduce the absorption of josamycin in the gastrointestinal tract.

special instructions

In patients with renal insufficiency, treatment should be based on the results of appropriate laboratory tests.

Consideration should be given to the possibility of cross-resistance to various macrolide antibiotics.

In the case of persistent severe diarrhea, one should keep in mind the possibility of developing life-threatening pseudomembranous colitis against the background of antibiotics.

Pregnancy and lactation

It is allowed to use during pregnancy and during breastfeeding after a medical assessment of the benefits / risks.

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

The drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

Overdose

Symptoms: increased side effects.

Treatment: supportive and symptomatic therapy. Ensuring sufficient fluid intake in the body.

Release form and packaging

5 tablets are placed in a blister pack of polyvinyl chloride / polyvinyl dichloride film and aluminum foil.

2 blister packs, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date!

Terms of dispensing from pharmacies

On prescription

Manufacturer

Famar Lyon, 29 Avenue Charles de Gaulle, 69230 Saint-Genis-Laval, France

Registration certificate holder

Astellas Pharma Europ B.V., The Netherlands

Silviusweg 62, 2333 VE Leiden, The Netherlands

Address of the organization that accepts claims from consumers in the territory of the Republic of Kazakhstan on the quality of products (goods), responsible for post-registration monitoring of the safety of the medicinal product:

Representative Office of Astellas Pharma Europe B.V. in RK

050059, Republic of Kazakhstan, Almaty, Al-Farabi Ave. 15, Business Center "Nurly Tau", building 4B, office No. 20

Phone/Fax +7 727 311 13 90 Pharmacovigilance. KZ@ astellas. com

Vilprafen Solutab

International non-proprietary name

Josamycin

Dosage form

Dispersible tablets 1000 mg

Compound

One tablet contains

active substance - josamycin 1000.0 mg, equivalent to josamycin propionate 1067. 66 mg,

Excipients: microcrystalline cellulose, hyprolose (L.M.), sodium docusate, aspartame, colloidal anhydrous silica, strawberry flavor 052311 AP 0551, magnesium stearate.

Description

White or white with a yellowish tint, oblong, sweet, strawberry-flavoured tablets, marked “IOSA” with a notch on one side and the words “1000” on the other.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Josamycin.

ATX code J01FA07

Pharmacological properties

Pharmacokinetics

Pharmacodynamics

Indications for use

Acute and chronic infections caused by susceptible microorganisms:

Tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis

Diphtheria (in addition to treatment with diphtheria antitoxic serum)

Scarlet fever, in case of hypersensitivity to penicillin

Acute bronchitis, exacerbation of chronic bronchitis

Pneumonia (including those caused by atypical pathogens)

Psittacosis

Gingivitis and periodontal disease

- blepharitis, dacryocystitis

Pyoderma, furunculosis, anthrax, erysipelas (with increased sensitivity to penicillin)

Acne, lymphangitis, lymphadenitis, inguinal lymphogranuloma

Prostatitis, urethritis, gonorrhea, syphilis (with increased sensitivity to penicillin)

Chlamydia, mycoplasma (including ureaplasma) and mixed infections

Dosage and administration

Daily dose for children from 5 to 14 years old is prescribed based on the calculation of 40 - 50 mg / kg of body weight daily, divided into 2-3 doses.

Treatment should be continued for more than 48 hours after the cessation of symptoms of the disease and the normalization of body temperature.

Side effects

(<1/10 000), не известно (частота не может быть оценена по имеющимся данным).

Bloating, stomatitis, nausea, vomiting, abdominal discomfort and diarrhea, pseudomembranous colitis, decreased appetite

Purpura, bullous dermatitis, erythema, Steven-Johnson syndrome, urticaria and skin reactions, angioedema, toxic epidermal necrolysis, anaphylactic reactions

- hepatic dysfunction and jaundice, usually characterized by, but not limited to, cholestatic reactions associated with mild renal impairment

Contraindications

hypersensitivity to macrolide antibiotics and other components of the drug

severe liver dysfunction

Drug Interactions

Vilprafen Solutab slightly affects the cytochrome P450 system, suppressing metabolism and increasing the plasma concentration of indirect anticoagulants, carbamazipine, valproic acid, disopyramide.

Vilprafen Solutab / other antibiotics

Vilprafen Solutab / xanthines

Vilprafen Solutab / antihistamines

Vilprafen Solutab / serotonin 5-HT 4 receptor agonists

Vilprafen Solutab / ergot alkaloids

Vilprafen Solutab / cyclosporine

Vilprafen Solutab / digoxin

With the joint appointment of Vilprafen Solutab and digoxin, an increase in the level of the latter in the blood plasma is possible.

Vilprafen Solutab / hormonal contraceptives

Vilprafen Solutab / triazolam

Josamycin may increase the effect of triazolam and cause drowsiness. In case of an overdose of triazolam, it is recommended to temporarily suspend treatment with the drug.

Vilprafen Solutab / Bromocriptine

Antacids slightly reduce the absorption of josamycin in the gastrointestinal tract.

special instructions

In patients with renal insufficiency, treatment should be based on the results of appropriate laboratory tests.

Consideration should be given to the possibility of cross-resistance to various macrolide antibiotics.

In the case of persistent severe diarrhea, one should keep in mind the possibility of developing life-threatening pseudomembranous colitis against the background of antibiotics.

Pregnancy and lactation

It is allowed to use during pregnancy and during breastfeeding after a medical assessment of the benefits / risks.

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

The drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

Overdose

Symptoms: increased side effects.

Treatment: supportive and symptomatic therapy. Ensuring sufficient fluid intake in the body.

Release form and packaging

5 tablets are placed in a blister pack of polyvinyl chloride / polyvinyl dichloride film and aluminum foil.

2 blister packs, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date!

Terms of dispensing from pharmacies

On prescription

Manufacturer

Famar Lyon, 29 Avenue Charles de Gaulle, 69230 Saint-Genis-Laval, France

Registration certificate holder

Astellas Pharma Europ B.V., The Netherlands

Silviusweg 62, 2333 VE Leiden, The Netherlands

Representative Office of Astellas Pharma Europe B.V. in RK

050059, Republic of Kazakhstan, Almaty, Al-Farabi Ave. 15, Business Center "Nurly Tau", building 4B, office No. 20

Phone/Fax +7 727 311 13 90 Pharmacovigilance. KZ@ astellas. com

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Vilprafen Solutab is a dispersible tablet that belongs to the macrolide class of antibacterial agents. This original drug is produced by the Italian company Montefarmaco S, but the applicant for registration is the Dutch pharmaceutical concern Astellas Pharm Europe.

Vilprafen Solutab is available in the form of a solid dosage form - soluble tablets of white or yellowish color. They have an oblong oval shape, in the middle of the tablet there is a risk for dividing the drug into equal parts. On one side of the surface of the tablet there is the inscription "IOSA", and on the other - 1000, which corresponds to the amount of the active substance josamycin.

The drug is packed in blisters for 5 cells and sold in a cardboard box of 5 or 10 tablets. The active ingredient is part of Vilprofen Solutab 1000 mg in the form of a salt - josamycin propionate. Auxiliary agents in the tablet are microcrystalline cellulose, weakly substituted hydroxypropyl cellulose, docusate sodium, aerosil, aspartame (E951), magnesium stearate, strawberry flavor.

Josamycin belongs to the macrolide class of antibiotics, which has a wide spectrum of action and has a bacteriostatic effect. The bactericidal effect is on microorganisms that are highly sensitive to the active substance.

Wilprafen Solutab 1000 photo

The mechanism of action of the drug is due to reversible binding to the 50S ribosome of the microorganism, which inhibits the synthesis of proteins in the bacterial cell and causes inhibition of its growth.

An important feature of the medicinal substance is its ability to act on the intracellular forms of microorganisms.

What helps Vilprafen Solutab?

Various types of staphylococci (including those producing beta-lactamase), streptococci of various types, anthrax bacilli, diphtheria corynebacterium, gonococci, meningococci, shigella, Haemophilus influenzae, pertussis, legionella, mycoplasma, chlamydia, treponema (causative agents syphilis), rickettsia, some anaerobic bacteria and fungi (Peptococcus spp, Bacteroides spp, Peptostreptococcus spp.).

Based on such a great therapeutic activity, it is possible to answer the question of what Vilprafen Solutab helps from:

Infectious diseases of the respiratory system and ENT organs (gingivitis, sinusitis, otitis media, laryngitis, pharyngitis, bronchitis, pneumonia, whooping cough, psittacosis);
Diseases of the urinary and genital infectious genesis: prostatitis, gonorrhea, urethritis, chlamydia, syphilis, mycoplasmosis, ureaplasmosis;
Bacterial skin lesions: pyoderma, acne, furunculosis, lymphadenitis, erysipelas, anthrax;
Eye diseases (inflammation in the eyelids or nasolacrimal canal of infectious etiology);
Other specific diseases: diphtheria, dysentery, scarlet fever, etc.

A special advantage of the drug is the possibility of its use in children in the treatment of bacterial infections of the respiratory tract, due to its pleasant taste and convenient dosage form. Vilprafen Solutab has proven itself well in the treatment of community-acquired pneumonia, especially in people with hypersensitivity to penicillins.

Vilprafen solutab is successfully used for the treatment of bacterial diseases of the reproductive system, which threaten the loss of reproductive function, miscarriages and intrauterine infection of the fetus. Josamycin has far fewer side effects than other antibiotics and is also less likely to cause resistant strains.

Instructions for use Vilprafen Solutab, dosage

According to the instructions for use of Vilprafen Solutab 500 \ 1000 - the maximum daily dose of the drug is 3 g, they are divided into 2-3 doses per day. Usually, therapy is carried out at the rate of 1.5-2 g of josamycin per day.

Tablets can be swallowed with plain water, without chewing, or dissolved in a small amount of liquid (at least 1 tablespoon of water). The drug is used before or after meals.

The duration of the course is determined by the attending physician, depending on the pathogen and the patient's condition, it can last from five days to three weeks.

The instructions indicate that for children from 1 year old, Vilprafen Solutab is prescribed based on the weight of the child, while his body weight should not be less than 10 kg. For 1 kg of the child's body, 40-50 mg of the drug is prescribed per day and the resulting dosage is divided into 2-3 doses.

With a body weight of more than 40 kg, the drug is taken in an adult dosage.

special instructions

Taking Vilprafen Solutab may affect the effect of certain drugs:

Taking this macrolide with some antiallergic drugs (terfenadine, astemizole) leads to life-threatening arrhythmias.
Slowing down the excretion of xanthines while taking josamycin can lead to theophylline intoxication.
With the combined use of Wilprafen with ergot alkaloids, severe vasoconstriction may occur.
An increase in nephrotoxicity is caused by the combined use of josamycin and cyclosporine.
Taking the drug with bactericidal agents inhibits the activity of the active substance.

The drug does not affect the ability to drive vehicles.

Side effects Wilprafen Solutab, contraindications

The most common side effects are abdominal pain, nausea and allergies (urticaria and other skin reactions). Much less common are constipation, diarrhea, problems with appetite, and vomiting. There is a possibility of developing pseudomembranous colitis. Manifestations of hepatic dysfunction and jaundice are possible. Taking high doses of the drug can lead to hearing loss.

Contraindications to the use of Vilprafen Solutab tablets are:

age up to 1 year;
weight less than 10 kg;
the presence of liver failure;
allergic reactions to the components of the drug;
history of hypersensitivity to other macrolides.

During pregnancy and lactation, taking the drug is not contraindicated, but this requires clear indications and a balanced decision by the doctor. So far, nothing has been reported about cases of overdose of the drug, so there is no specific antidote and symptomatic treatment against the background of detoxification therapy is expected.

Vilprafen Solutab analogs, list of drugs

To date, among the analogues of Vilprafen Solutab there is only one drug - Vilprafen, it is produced by the same pharmaceutical company.

What is better Vilprafen or Vilprafen Solutab?

Vilprafen Solutab tablets differ from Vilprafen tablets in their solubility, which significantly affects the pharmacokinetics of the drug.

The use of Solutab technology provides better bioavailability of the active ingredient. It is achieved due to the uniform distribution of microparticles in the stomach and the controlled release of josamycin as water penetrates into the microparticles. Complete release occurs in the "window of reabsorption" - the duodenum.

Also, the difference between the two forms of the drug is the dosage - 1000 mg and 500 mg, respectively, so Vilprafen Solutab can be used less frequently, which significantly reduces the risk of side effects.

The dispersible tablet form has a pleasant taste and is easy to give to children from as early as 1 year of age. In addition, the cost of treatment with Vilprafen Solutab is approximately 30% cheaper than with Vilprafen alone. Thus, it is safe to say that the soluble form of tablets is much better and more convenient.

Vilprafen Solutab is a modern antibacterial agent with a wide spectrum of action, which can be used according to indications even for children and during pregnancy. The drug is easy to take, has few side effects and a low chance of developing resistant strains. The effectiveness of the drug is very high and clinically proven.

Vilprafen is widely used to treat bacterial and fungal diseases.

The drug belongs to the group of macrolides - antibiotics, similar in action to penicillins. It has a bacteriostatic, and in large doses, a bactericidal effect. It is almost completely metabolized in the body, and its residues and metabolites are excreted in the urine.

On this page you will find all the information about Vilprafen: full instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Vilprafen. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Macrolide antibiotic.

Terms of dispensing from pharmacies

Released by prescription.

Prices

How much does Wilprafen cost? The average price in pharmacies is at the level of 600 rubles.

Release form and composition

The drug Vilprafen is available in the form of tablets for oral administration in a carton box in blisters of 10 pieces. Each tablet is film-coated in white color and has a horizontal notch on one side.

active substance: josamycin - 500 mg,
excipients: microcrystalline cellulose, polysorbate 80, colloidal silicon oxide, sodium carboxymethylcellulose, magnesium stearate, hydroxypropyl methylcellulose, Macrogol 6000, talc, titanium dioxide, aluminum hydroxide, copolymer of methacrylic acid and its esters.

Pharmacological effect

The bactericidal effect of the active substance of the drug is due to the fact that josamycin is able to bind to the large subunit of the ribosomal membrane (50S), prevents the transfer RNA from being fixed, and also blocks the translocation of the A-center peptides (a type of mutation that is accompanied by a chromosomal rearrangement that affects the properties of the cell) and inhibits intracellular production of proteins from amino acids.

The spectrum of action of josamycin, which is part of Vilprafen, is quite wide.

The substance has activity against gram-positive aerobic microorganisms, including:

Released by the body during inflammatory processes of peptococci;
Peptostreptococci, which provoke the development of mixed infections;
Staphylococcus;
The causative agent of anthrax is bacillus anthrax;
Bacteria of the genus Corynebacterium, which are the causative agents of diphtheria;
Clostridium perfringens - causative agents of gas gangrene and human toxicoinfections;
Streptococcus.

Vilprafen is also active against gram-negative microorganisms, including:

Hemophilus, which is the cause of hemophilic infections, including purulent meningitis, acute pneumonia, pericarditis, septicemia, etc.;
Neisseria, which are the causative agents of diseases such as gonorrhea and meningitis;
Some varieties of shigella, which provokes the development of dysentery;
Bacteroides fragilis, which are the causative agents of purulent infectious diseases that develop after trauma, surgery, immunodeficiency, etc.;

Indications for use

According to the instructions, Vilprafen is prescribed for the treatment of the following infectious and inflammatory diseases caused by microorganisms sensitive to josamycin:

Psittacosis;
Infections in ophthalmology (dacryocystitis, blepharitis);
Infections in dentistry (pericoronitis, periodontitis and alveolar abscess);
Burn and wound (including postoperative) infections;
, venereal lymphogranuloma, (with increased sensitivity to penicillin);
Infections of the ENT organs and upper respiratory tract, including paratonsillitis and;
Infections of the lower respiratory tract, including community-acquired, acute and (exacerbations);
(Vilprafen is prescribed in case of hypersensitivity to penicillin antibiotics);
(in complex therapy together with diphtheria antitoxin);
Infections of the genital organs and urinary tract (, and epididymitis caused by mycoplasmas and / or chlamydia);
Infections of soft tissues and skin (furunculosis, furuncle, anthrax, acne, abscess, folliculitis, lymphadenitis, panaritium, lymphangitis and phlegmon);
Diseases of the gastrointestinal tract caused by, including and and.

Contraindications

The drug is contraindicated in severe violations of the liver or in the presence of hypersensitivity to the components of the drug.

Use during pregnancy and lactation

The drug is not prescribed for pregnant women if there are severe disorders in the liver, sensitivity to the constituent components.

Instructions for use

For the treatment of rosacea - 500 mg 2 times / day for 10-15 days.
For the treatment of pyoderma - 500 mg 2 times / day for 10 days.
For the treatment of urogenital chlamydia - 500 mg 2 times / day for 12-14 days.
For the treatment of chronic periodontitis, with abscessing of the periodontal bone - 500 mg 2 times / day for 12-14 days.
With ordinary and spherical (conglobat) acne, 500 mg 2 times / day are prescribed for the first 2-4 weeks, then 500 mg 1 time / day as maintenance therapy for 8 weeks.

Tablets should be swallowed without chewing, with a small amount of liquid, between meals. Usually the duration of treatment is determined by the doctor. In accordance with WHO recommendations on the use of antibiotics, the duration of treatment for streptococcal infections should be at least 10 days.

For infants and children under the age of 14, it is preferable to prescribe the drug in the form of a suspension. The daily dose is 30-50 mg / kg of body weight, divided into 3 doses. In newborns and children under the age of 3 months, the dose should be adjusted according to the exact body weight of the child.

Shake the vial with the suspension before use.

Side effects

With proper use of the drug and strict adherence to the dose indicated in the instructions, Vilprafen is well tolerated by patients, but in some cases the following side effects may develop:

Allergic skin reactions: , rash, in very rare cases, anaphylactic shock.
Gastrointestinal tract: nausea, abdominal pain, profuse salivation, heartburn, vomiting, intractable diarrhea, the development of an inflammatory process in the intestine in rare cases.
From the side of the liver and biliary tract: an increase in the activity of hepatic transaminases, rarely a violation of the outflow of bile and the functioning of the gallbladder, due to which jaundice developed in patients.

Overdose

So far, no cases of overdose have been reported with regard to the drug. In case of an overdose after taking the drug, it is necessary to assume an increase in side effects, to carry out symptomatic therapy.

special instructions

In patients with renal insufficiency, correction of the dosing regimen is required in accordance with the CC values.
Josamycin is not prescribed to premature babies. When used in newborns, it is necessary to monitor liver function.
In the event of the development of pseudomembranous colitis, josamycin should be discontinued and appropriate therapy instituted. Drugs that reduce intestinal motility are contraindicated.

Consideration should be given to the possibility of cross-resistance to various antibiotics of the macrolide group (for example, microorganisms resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin).

drug interaction

Vilprafen inhibits the elimination of xanthines, which can provoke the development of intoxication.
It is recommended to avoid the simultaneous use of Vilprafen with other antibiotics. This can lead to a decrease in their effectiveness.
The simultaneous use of an antibiotic with cyclosporine can lead to an increase in the concentration of the latter, so its level should be monitored throughout the treatment.
Taking Vilprafen may reduce the effectiveness of hormonal contraceptives, therefore, in order to avoid unwanted pregnancy, it is recommended to additionally use non-hormonal contraceptives.
The complex use of Vilprafen with antihistamines, including astemizole and terfenadine, increases the concentration of the latter, which can lead to the development of serious life-threatening cardiac arrhythmias.