Which group of antibiotics does josamycin belong to? Josamycin (Vilprafen) - a macrolide antibiotic for special cases

Restoration of microflora

Probiotics

Macrolide antibiotics have a high activity against many infectious agents. One of the representatives of this group of antibacterial agents is Vilprafen Solutab. Is this drug allowed for children, what microorganisms does it affect, how is it used correctly, and what side effects can it provoke?

Release form

The drug is presented as dispersible white-yellow or white oblong tablets. They are sweet in taste, smell like strawberries. On one side of the tablet there is the number 1000, and the other side is marked with the inscription IOSA. The drug is packed in blisters of 5 pieces, and one pack includes 10 tablets.

Compound

The main component of the anbitiotik Vilprafen Solutab is represented by josamycin. Its dosage per tablet is 1000 mg. To make the drug solid, keep its shape and dissolve in water, colloidal silicon dioxide, hyprolose and magnesium stearate are added to it, as well as sodium docusate and microcrystalline cellulose. For a pleasant taste, the preparation contains strawberry flavor and aspartame.

Operating principle

Josamycin has a bacteriostatic effect due to the binding of this substance to the ribosomes of microbial cells, as a result of which the synthesis of protein molecules is disrupted in bacteria. This leads to a slowdown in the reproduction and growth of microorganisms.

The drug is active against:

• Streptococci (including pneumococci and pyogenic species).
• The causative agents of diphtheria.
• meningococci.
• Peptococcus.
• Listeria.
• Staphylococci (including aureus).
• Gonococcus.
• Legionell.
• The causative agents of anthrax.
• Bordetell.
• Clostridia.
• Borelli.
• Pale treponemas.
• Propionobacteria.
• Peptostreptococcus.
• Ureaplasma.
• Moraxell.
• Brucella.
• Gonococcus.
• Helicobacter.
• Hemophilic rods.
• Chlamydia.
• Bacteroids.
• Campylobacter.
• Mycoplasma.

In this case, the drug is often inactive when infected with enterobacteria. It has almost no effect on the normal intestinal microflora. Note also that the drug usually acts on strains of microbes that are resistant to erythromycin and other macrolides.

The tablet is very quickly absorbed in the digestive tract, and food intake does not affect this process in any way. The maximum josamycin in plasma is determined approximately one hour after taking the drug. The half-life of the drug is carried out in 1-2 hours, while only 10% of the drug is excreted by the kidneys, and most of it is excreted in the bile after metabolic changes in the liver.

Indications

Treatment with the drug "Vilprafen Solutab" is prescribed:

• With tonsillitis, otitis media, paratonsillitis, scarlet fever, tonsillitis, diphtheria, laryngitis and other infections of the upper respiratory tract.
• With bronchitis, whooping cough, community-acquired pneumonia and other bacterial infections of the lower respiratory tract.
• With alveolitis, gingivitis, periodontitis and other dental infections.
• With bacterial lesions of the eyes - for example, with blepharitis.
• With erysipelas, phlegmon, panaritium, furunculosis, burn infection, lymphadenitis and other soft tissue lesions.
• With gonorrhea, chlamydial urethritis, syphilis and other urinary tract infections.
• With diseases of the gastrointestinal tract caused by Helicobacter pylori.

From what age is it applied?

The restriction in the appointment of "Vilprafen Solutab" is not the age of the child, but his weight. The drug is allowed only for children weighing more than 10 kilograms. This means that the drug can be prescribed to one child at 6 months, and tablets can be given to another toddler only from 1 year. It all depends on body weight.

Contraindications

"Vilprafen Solutab" is not prescribed if the child has:

• There is an intolerance to josamycin or other ingredients of the tablets.
• An allergy to any macrolide antibiotic was found.
• The work of the liver is severely impaired.

Side effects

The child's body can react to "Vilprafen Solutab" with the appearance of:

• Nausea.
• Discomfort in the stomach.
• Vomiting.
• Liquefaction of the stool.

Rare side effects from taking such an antibiotic: constipation, Quincke's edema, decreased appetite, stomatitis, urticaria, jaundice, hearing impairment or purpura.

Instructions for use and dosage

• "Vilprafen Solutab" can be taken in different ways - how to swallow a tablet or part of it with water, and dissolve the drug in water, taking a liquid in a volume of 20 ml or more. If the drug dissolves, the suspension must be mixed well before swallowing.
• The daily dose of "Vilprafen Solutab" for a child is calculated by weight. For 1 kilogram of body weight, you need from 40 to 50 mg of the active substance. For example, a child of 4 years old with a weight of 16 kg will receive 750 mg of josamycin per day, so he is given 1/4 tablet three times a day. If the baby is 6 years old, and his weight is 20 kg, then the daily dose will be 50x20 = 1000 mg. This amount corresponds to 1 tablet. For such a small patient, the medication is prescribed 1/2 tablet twice a day.
• At the age of over 14, 1-2 pieces per day are prescribed, dividing this dosage into 2 or 3 doses. If required, the dose can be increased up to 3 tablets per day.
• How long to drink the drug - in each case, the doctor determines individually. The duration of taking an antibiotic can be either 5 days or 3 weeks. For example, with streptococcal angina, Wilprafen Solutab is prescribed for at least 10 days.

Overdose

So far, there have been no cases of overdose, but doctors suggest that exceeding the dose of soluble tablets will lead to a negative reaction of the digestive tract (in the form of vomiting, stomach discomfort or diarrhea). In case of problems, you should consult a doctor.

Interaction with other drugs

• "Vilprafen Solutab" is not prescribed together with any bactericidal antibiotics, as well as with representatives of the lincosamide group.
• If you take antihistamines (astemizole or terfenadine drugs) at the same time, the risk of heart rhythm disturbances increases.
• It is not advised to combine treatment with josamycin and xanthines, cyclosporine or ergot alkaloids.

Terms of sale

Buying "Vilprafen Solutab" requires a prescription from a doctor. The average cost of one package of medicine is 650 rubles.

Storage Features

To store the drug, you should find a place where the medicine cannot be reached by a small child. The temperature during storage of the medicine should not exceed 25 degrees Celsius. The shelf life of dispersible tablets is 2 years.

Included in medications

Included in the list (Decree of the Government of the Russian Federation No. 2782-r dated December 30, 2014):

VED

ONLS

ATH:

J.01.F.A.07 Josamycin

Pharmacodynamics:

The drug is an antibiotic of the macrolide group with a predominantly gram-positive spectrum of action. The bacteriostatic effect of the drug is due to the inhibition of protein synthesis in bacteria at the stage of translocation. At high local concentrations, it exhibits a bactericidal effect.The drug is especially effective against intracellular microorganisms, such as Chlamydia trachomatis,Chlamydia pneumoniae, Mycoplasma pneumoniae,Mycoplasma hominis,Ureaplasma urealyticum, Legionella pneumophila, and is also effective against Staphylococcus aureus,Streptococcus pyogenes,Streptococcus pneumoniae (pneumococcus),Corynebacterium diphtheria, Neisseria meningitidis,Neisseria gonorrhoeae,haemophilus influenzae,Bordetella pertussis,Peptococcus,Peptostreptococcus,Clostridium perfringens, Treponema pallidum.

Pharmacokinetics:

Rapidly absorbed in the gastrointestinal tractregardless of food, the connection with plasma proteins is not more than 15%, it is metabolized in the liver, excreted in the bile and urine (20%).

Indications:

Infections of the skin and soft tissues; And genital and urinary tract infections; infectious and inflammatory diseases caused by microorganisms sensitive to josamycin; diphtheria; infections of the lower respiratory tract; oral infections; chlamydial, mycoplasmal and mixed infections of the urinary tract and genital organs; scarlet fever.

I.A20-A28.A22 Anthrax

I.A30-A49.A31.0 Lung infection due to Mycobacterium

I.A30-A49.A36 Diphtheria

I.A30-A49.A37 Whooping cough

I.A30-A49.A38 Scarlet fever

I.A30-A49.A46 Erysipelas

I.A30-A49.A48.1 Legionnaires' disease

I.A50-A64.A50 congenital syphilis

I.A50-A64.A51 Early syphilis

I.A50-A64.A52 Late syphilis

I.A50-A64.A54 Gonococcal infection

I.A50-A64.A55 Chlamydial lymphogranuloma (venereal)

I.A50-A64.A56.0 Chlamydial infections of the lower urinary tract

I.A50-A64.A56.1 Chlamydial infections of the pelvic organs and other urinary organs

I.A50-A64.A56.4 Chlamydial pharyngitis

I.A70-A74.A70 Chlamydia psittaci infection

I.B95-B97.B96.0 Mycoplasma pneumoniae as the cause of diseases classified elsewhere

VIII.H65-H75.H66 Purulent and unspecified otitis media

X.J00-J06.J01 Acute sinusitis

X.J00-J06.J02 Acute pharyngitis

X.J00-J06.J03 Acute tonsillitis

X.J00-J06.J04 Acute laryngitis and tracheitis

X.J10-J18.J15 Bacterial pneumonia, not elsewhere classified

X.J10-J18.J15.7 Pneumonia due to Mycoplasma pneumoniae

X.J10-J18.J16.0 Pneumonia due to chlamydia

X.J20-J22.J20 Acute bronchitis

X.J30-J39.J31 Chronic rhinitis, nasopharyngitis and pharyngitis

X.J30-J39.J32 Chronic sinusitis

X.J30-J39.J35.0 Chronic tonsillitis

X.J30-J39.J37 Chronic laryngitis and laryngotracheitis

X.J40-J47.J42 Chronic bronchitis, unspecified

XI.K00-K14.K05 Gingivitis and periodontal disease

XI.K00-K14.K12 Stomatitis and related lesions

XII.L00-L08.L01 Impetigo

XII.L00-L08.L02 Skin abscess, furuncle and carbuncle

XII.L00-L08.L03 Phlegmon

XII.L00-L08.L08.0 Pyoderma

XIV.N10-N16.N10 Acute tubulointerstitial nephritis

XIV.N10-N16.N11 Chronic tubulointerstitial nephritis

XIV.N30-N39.N30 Cystitis

XIV.N30-N39.N34 Urethritis and urethral syndrome

XIV.N40-N51.N41 Inflammatory diseases of the prostate

XIV.N40-N51.N45 Orchitis and epididymitis

XIV.N70-N77.N70 Salpingitis and oophoritis

XIV.N70-N77.N71 Inflammatory diseases of the uterus, except for the cervix

XIV.N70-N77.N72 Inflammatory disease of the cervix

XIV.N70-N77.N73.0 Acute parametritis and pelvic cellulitis

XIV.N70-N77.N74.2* Pelvic inflammatory disease due to syphilis (A51.4+, A52.7+)

XIV.N70-N77.N74.3* Gonococcal inflammatory diseases of female pelvic organs (A54.2+)

XIV.N70-N77.N74.4* Inflammatory diseases of the female pelvic organs due to chlamydia (A56.1+)

Contraindications:

Liver dysfunction, hypersensitivity, prematurity of children.

Carefully:

Interval lengthening Q T , arrhythmias (history), renal failure, jaundice, porphyria, breastfeeding, myasthenia gravis.

Pregnancy and lactation:

Category Food and Drug Administration ( US Food and Drug Administration) not determined. Use during pregnancy and lactation is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or child.

In the treatment of macrolides and the simultaneous use of hormonal contraceptives, non-hormonal contraceptives should be additionally used.

Dosage and administration:

inside. Children under the age of 14 - 30-50 mg / kg per day for 3 doses.

Children over 14 years old and adults - 1-2 grams per day for 2-3 doses.

Side effects:

From the digestive system: rarely - lack of appetite, nausea, heartburn, vomiting, diarrhea, pseudomembranous colitis; in some cases - an increase in the activity of hepatic transaminases, a violation of the outflow of bile and jaundice.

Allergic reactions: rarely - urticaria.

Others: in some cases - dose-dependent transient hearing loss.

Overdose:

Liver dysfunction, hearing loss, increased side effects. Treatment is symptomatic.

Interaction:

When taken simultaneously with lincomycin, the activity of both drugs decreases.

The drug enhances the nephrotoxicity of cephalosporin.

The drug may reduce the contraceptive effect of hormonal contraceptives.

Alcohol - an increase in the maximum concentration of alcohol in the blood by 40% when used simultaneously with josamycin for intravenous administration.

Alfentanil - an increase in the period of action of alfentanil with long-term use of macrolides (inhibition of liver enzymes).

Astemizole, terfenadine, cisapride - increased risk of toxic effects on the heart, ventricular fibrillation-flutter, paroxysmal tachycardia and death. Application is contraindicated!

Warfarin - an increase in the risk of bleeding, especially in the elderly, due to an increase in prothrombin time, a weakening of the metabolism and clearance of warfarin, the use requires monitoring of prothrombin time.

Glucocorticoids - suppression of their biotransformation.

Digoxin - an increase in its content, due to an obstacle to inactivation in the intestine (changes in the intestinal flora under the influence of josamycin).

Other drugs that have an ototoxic effect - an increase in the risk of the latter, especially when using high doses and in violation of kidney function.

Carbamazepine - an increase in their concentration in the blood, the development of a toxic effect, simultaneous use is not recommended.

Xanthines: (eufillin), - increase in blood concentration and toxicity of xanthines due to a decrease in their clearance in the liver (after 6 days).

Penicillins and cephalosporins - an obstacle to the development of the bactericidal effect of penicillins due to bacteriostatic action.

Means that have a hepatotoxic effect - an increase in the risk of toxic effects on the liver.

Means that lengthen the QT interval - an increase in the risk of arrhythmias.

Statins - increased risk of acute rhabdomyolysis after erythromycin treatment ends.

Triazolam and - enhancing the pharmacological effects of these drugs by reducing their clearance.

Special instructions:

For patients with chronic kidney disease, a special dose selection is required.

When prescribing the drug to newborns, monitoring of liver function is necessary.

In case of development of pseudomembranous colitis, it should be canceled and appropriate therapy should be prescribed. 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).

Instructions

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 tint, oblong-shaped tablets, sweet, with a strawberry smell. 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; The bacteriostatic activity of josamycin, like other macrolides, is due to the 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, Clo stridium perfringens). 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 mainly 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, followed by 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,

| Josamycin

Analogues (generics, synonyms)

Azivok, Azitral, Azitrox, Azithromycin, AzitRus, Azitsid, Arvicin, Arvicin retard, Benzamycin, Binoclar, Vilprafen, Vilprafen solutab, Grunamycin syrup, Dinabak, Zetamax retard, Zimbaktar, Zinerit, Zitrolide, Zitrocin, Ilozone, Klabaks, Klarbakt, Clarithromycin , Claricin, Clasine, Klacid, Crixan, Xitrocin, Lecoclar, Macropen, Oleandomycin phosphate, Oletetrin, Pylobact, Rovamycin, Roxide, Roxilor, Roxithromycin, Romiclar, Rulid, Safocid, Spiramycin, Sumaclid, Sumamed, Sumametsin, Sumamox, Sumatrolide solutab, Fromili d , Fromilid Uno, Hemomycin, Ecomed, Elrox, Erythromycin, Ermiced, Esparoxy

Recipe (International)

Rep.: Tab. Josamycini 0.5.
D.S.: Take 2 tablets 2 times a day.

Prescription form - 107-1/u (Russia)

pharmachologic effect

Reversibly binds to the 50S subunit of ribosomes, inhibits protein synthesis and reproduction of microbial cells (bacteriostatic effect). When creating high concentrations in the focus of inflammation, it has a bactericidal effect. It has a wide range of action, including gram -positive (Staphylococcus spp., Production and non -producing penicillinase, Streptococcus spp., Bet. Streptococcus pyogenes and streptococcus pneumoniae, Bacalalus Anthrac IS, Corynebacterium diphtheriae) and gram -negative (neisseria gonorrhoeae, neisseria meningitidis, some species Shigella, Haemophilus influenzae, Bordetella pertussis) bacteria, intracellular microorganisms (Mycoplasma spp., including Mycoplasma hominis, Mycoplasma pneumoniae, Chlamydia spp., including Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Legionella pneumophila) and some anaerobes (Peptococcus, Peptostreptococcus, Clostridium perfringens, Bacteroides fragillis). 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.

When administered to pregnant female mice and rats during the period of organogenesis at a high dose (3 g / kg), it increased mortality rates and caused fetal growth retardation without signs of teratogenic effects.

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract, food intake does not affect bioavailability. Cmax in serum is achieved after 1-2 hours and is at a single dose of 400 mg - 0.33 mg / l, 500 mg - 0.67-0.71 mg / l, 1000 mg - 2.4 mg / l, 1250 mg - (2.08±1.13) mg/l, 2000 mg - (5.79±2.47) mg/l. Plasma protein binding is about 15%. It dissolves well in fats and is slightly ionized at normal pH values ​​​​of blood and tissue fluids, it penetrates well through histohematic barriers into various organs and tissues. The volume of distribution is 300.56 liters. Particularly high concentrations are found in the lungs, tonsils, saliva, sweat and lacrimal fluid. The concentration in sputum exceeds the concentration in blood plasma by 8-9 times.

Accumulates in bone tissue. Able to penetrate and accumulate in adenoids, middle ear exudate, paranasal sinus secretion, gums, prostate gland. It practically does not penetrate into the cerebrospinal fluid, passes through the placenta and is secreted into breast milk. Biotransformirovatsya in the liver with the formation of less active metabolites. At least three metabolites were found: 14-hydroxyjosamycin, hydroxyjosamycin, and deisovaleryljosamycin. T1 / 2 - 4 hours.

Excreted mainly with bile, less than 20% - with urine.

Mode of application

For adults: When taken orally, adults and children over 14 years of age - 1-2 g per day in 2-3 divided doses. Children under the age of 14 - 30-50 mg / kg per day in 3 divided doses. The duration of treatment depends on the indications for use.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to josamycin:

infections of the upper respiratory tract and ENT organs (including pharyngitis, tonsillitis, paratonsillitis, otitis media, sinusitis, laryngitis);
diphtheria (in addition to treatment with diphtheria antitoxin);
scarlet fever (with increased sensitivity to penicillin);
infections of the lower respiratory tract (including acute bronchitis, bronchopneumonia, pneumonia, including atypical form, whooping cough, psittacosis);
oral infections (including gingivitis and periodontal disease);
infections of the skin and soft tissues (including pyoderma, boils, anthrax, erysipelas (with increased sensitivity to penicillin), acne, lymphangitis, lymphadenitis);
infections of the urinary tract and genital organs (including urethritis, prostatitis, gonorrhea);
with increased sensitivity to penicillin - syphilis, venereal lymphogranuloma);
chlamydial, mycoplasmal (including ureaplasma) and mixed infections of the urinary tract and genital organs.

Contraindications

Hypersensitivity (including to other macrolides), severe liver dysfunction, prematurity of children

Side effects

lack of appetite;
nausea,
vomit;
heartburn;
diarrhea;
pseudomembranous colitis;
increased activity of hepatic transaminases; violation of the outflow of bile and jaundice;
hives;
dose-dependent transient hearing loss.

Release form

Film-coated tablets 500 mg and 1000 mg.

ATTENTION!

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