Vilprafen Solutab 1000 mg No. 10 dispersible tablet.
Instructions for the medical use of the drug Vilprafen Solutab Trading name Vilprafen Solutab International Nepatent name Josamycin Disma of tablet dispersed 1000 mg. The tablet contains an active substance - josamycin 1000.0 mg, equivalent to Josamycin 1067. 66 mg, auxiliary substances: cellulose microcrystallic , giplose (lm ), sodium docusate, aspartame, colloidal anhydrous silicon dioxide, strawberry flavor 052311 AR 0551, magnesium stearate. Description White or white with a yellowish tint, oblong-shaped tablets, sweet, with the smell of strawberries, with the inscription “IOSA” and a line mark on one side and the inscription “1000” on the other. Pharmacotherapeutic group Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Josamycin. ATC code J01FA07 Pharmacological properties Pharmacokinetics After oral administration, josamycin is quickly and completely absorbed from the gastrointestinal tract; food intake does not affect bioavailability. The maximum serum concentration of josamycin is achieved 1-2 hours after administration. About 15% of josamycin is bound to plasma proteins. Particularly high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Crosses the placental barrier and is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and excreted mainly in bile. Excretion of the drug in 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 high concentrations are created at the site 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, Clostrid ium perfringens). It has a slight effect on enterobacteria, and therefore little changes the natural bacterial flora of the gastrointestinal tract. Effective against resistance to erythromycin. Resistance to Vilprafen Solutab develops less frequently than to other macrolide antibiotics. Indications for use Acute and chronic infections caused by microorganisms sensitive to the drug: - 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 diseases - blepharitis, dacryocystitis - pyoderma, furunculosis, anthrax, erysipelas (with hypersensitivity to penicillin) - acne, lymphangitis, lymphadenitis, inguinal lymphogranuloma - prostatitis, urethritis, gonorrhea, syphilis (with hypersensitivity to penicillin) - chlamydial, mycoplasma (including ureaplasma) and mixed infections Method of administration and dosage Vilprafen Solutab dispersible tablets can be taken in two different ways: they can be swallowed whole with a drink water or dissolve in water before use. The tablets should be dissolved in at least 20 ml of water. Before administration, the resulting suspension should be mixed thoroughly. The recommended daily dose for adults and adolescents over the age of 14 years 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. The daily dose for children from 5 to 14 years is prescribed based on the calculation of 40 - 50 mg/kg body weight daily, divided into 2-3 doses. In the case of ordinary and globular acne, it is recommended to prescribe Vilprafen Solutab at a dose of 500 mg twice a day for the first 2-4 weeks, then 500 mg of the drug once a day as maintenance treatment for 8 weeks. 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. Side effects Rarely - loss of appetite, nausea, heartburn, vomiting, dysbacteriosis, flatulence, diarrhea, pseudomembranous colitis Very rarely - skin allergic reactions - transient increase in the activity of liver enzymes in the blood plasma, in rare cases accompanied by impaired outflow of bile and jaundice, cholestatic hepatitis - dose-dependent transient hearing impairment - candidiasis - hypovitaminosis Contraindications - hypersensitivity to macrolide antibiotics and other components of the drug - severe liver dysfunction Drug interactions Vilprafen Solutab has a slight effect on the cytochrome P450 system, suppressing metabolism and increasing the plasma concentration of indirect anticoagulants, carbamazipine, valproic acid acids, disopyramide. Vilprafen Solutab / other antibiotics Since bacteriostatic antibiotics can reduce the bactericidal effect of other antibiotics, such as penicillins and cephalosporins, co-prescribing the drug with these types of antibiotics should be avoided. It should not be prescribed together with lincomycin, as 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 Vilprafen Solutab has less effect on the release of theophylline than other macrolide antibiotics. Vilprafen Solutab / antihistamines After co-administration of the drug and drugs containing terfenadine and astemizole, a slowdown in the elimination of terfenadine or astemizole may be observed, which in turn can lead to the development of life-threatening cardiac arrhythmias caused by prolongation of the QT interval. Vilprafen Solutab / serotonin 5-HT 4 receptor agonists Co-administration of Vilprafen Solutab and drugs containing cisapride may result in a slower elimination of cisapride, which in turn can lead to the development of life-threatening cardiac arrhythmias caused by prolongation of the QT interval. Vilprafen Solutab / ergot alkaloids There are individual reports of increased vasoconstriction after 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 When Vilprafen Solutab and digoxin are co-administered, the level of the latter in the blood plasma may increase. 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 contraception. Antacids slightly reduce the absorption of josamycin in the gastrointestinal tract. Special instructions In patients with renal failure, treatment should be carried out taking into account the results of appropriate laboratory tests. The possibility of cross-resistance to various macrolide antibiotics should be taken into account. In the case of persistent severe diarrhea, one should keep in mind the possibility of life-threatening pseudomembranous colitis developing against the background of antibiotics. Pregnancy and lactation Use during pregnancy and breastfeeding is permitted according to indications. WHO Europe recommends josamycin as the drug of choice for the treatment of chlamydial infection in pregnant women. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms The drug does not affect the ability to drive vehicles or potentially dangerous mechanisms. Overdose Symptoms: increased side effects. Treatment: supportive and symptomatic therapy. Ensuring sufficient fluid intake into the body. Release form and packaging 5 tablets are placed in a blister pack made 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 place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration date! Conditions for dispensing from pharmacies By prescription Manufacturer Famar Lyon, 29 Avenue Charles de Gaulle, 69230 Saint-Genis-Laval, France Marketing authorization holder Astellas Pharma Europe B.V., the Netherlands Silviusweg 62, 2333 VE Leiden, the Netherlands Address of the receiving organization in the territory of the Republic of Kazakhstan, claims from consumers regarding product (product) quality: Representative office of Astellas Pharma Europe B.V. in the Republic of Kazakhstan Almaty, 050559, Al-Farabi Ave. 15, PFC "Nurly Tau", building 4B, office No. 20 Phone Fax www.astellas.ru, e-mail
Vilprafen Solutab 1g No. 10 Tablets
Tradename:
Vilprafen solutab
International nonproprietary name:
Josamycin
Compound
Active substance: Josamycin - 1000 mg (equivalent to josamycin propionate) - 1067.66 mg. Excipients: Microcrystalline cellulose - 564.53 mg, hyprolose - 199.82 mg, sodium docusate - 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 the smell of strawberries. With the inscription “JOSA” and a line mark on one side of the tablet and the inscription “1000” on the other.
Pharmacotherapeutic group:
antibiotic, macrolide. PBX code: J01FA07
Pharmacological properties
Pharmacodynamics.
The drug is used to treat bacterial infections; The bacteriostatic activity of josamycin, like other macrolides, is due to inhibition of bacterial protein synthesis. When high concentrations are created at the site 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, Clostrid ium perfringens). It has a slight effect on enterobacteria, and therefore little changes the natural bacterial flora of the gastrointestinal tract. Effective against resistance to erythromycin. Resistance to josamycin develops less frequently than to other macrolide antibiotics.
Pharmacokinetics.
After oral administration, josamycin is quickly and completely absorbed from the gastrointestinal tract; food intake does not affect bioavailability. The maximum serum concentration of josamycin is achieved 1-2 hours after administration. About 15% of josamycin is bound to plasma proteins. Particularly high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Crosses the placental barrier and is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and excreted mainly in bile. Excretion of the drug in urine is less than 20%.
Indications for use
Acute and chronic infections caused by microorganisms sensitive to the drug, for example: Infections of the upper respiratory tract and ENT organs: Sore throat, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), as well as scarlet fever in case of increased sensitivity 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. Infections of the skin and soft tissues Pyoderma, furunculosis, anthrax, erysipelas (with hypersensitivity to penicillin), acne, lymphangitis, lymphadenitis, lymphogranuloma venereum. Infections of the genitourinary system Prostatitis, urethritis, gonorrhea, syphilis (with hypersensitivity to penicillin), chlamydial, mycoplasma (including ureaplasma) and mixed infections.
Contraindications
hypersensitivity to macrolide antibiotics, severe liver dysfunction
Pregnancy and lactation
Use during pregnancy and breastfeeding is permitted after a medical assessment of the benefits/risks. WHO Europe recommends josamycin as the drug of choice for the treatment of chlamydial infection in pregnant women.
Directions for use and doses
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 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 tablet dissolved in water) 2 times a day, for children weighing 20-40 kg the drug is prescribed at 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 in 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 times a day + josamycin 1 g 2 times a day). day + metronidazole 500 mg twice a day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) twice a day + amoxicillin 1 g twice a day + josamycin 1 g twice a day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) twice a day + amoxicillin 1 g twice a day + josamycin 1 g twice a day + bismuth tripotassium dicitrate 240 mg twice a day: famotidine 40 mg/day + furazolidone 100 mg twice a day + josamycin 1 g twice a day + bismuth tripotassium dicitrate 240 mg twice a day). In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: Amoxicillin 1 g 2 times a day + josamycin 1 g 2 times a day + tripotassium bismuth d and citrate 240 mg 2 times a day. For acne vulgaris and acne globulus, it is recommended to prescribe josamycin 500 mg twice daily for the first 2-4 weeks, followed by 500 mg josamycin once daily as maintenance treatment for 8 weeks. Vilprafen Solutab dispersible tablets can be taken in various ways: the tablet can be swallowed whole with water or dissolved in water before use. The tablets should be dissolved in at least 20 ml of water. Before administration, the resulting suspension should be thoroughly mixed.
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 life-threatening pseudomembranous colitis developing against the background of antibiotics. Hypersensitivity reactions: In extremely rare cases, allergic skin reactions (for example, urticaria) are possible. From 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 hearing system In rare cases, dose-dependent transient hearing impairment has been reported. Other: very rarely - candidiasis.
Interaction with other drugs
Vilprafen Solutab / other antibiotics: Since bacteriostatic antibiotics can 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 prescribed together with lincomycin, as 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 experimental studies indicate that josamycin has less effect on theophylline release than other macrolide antibiotics. Vilprafen Solutab / antihistamines: After co-administration of josamycin and antihistamines containing terfenadine or astemizole, a slowdown in the elimination of terfenadine and astemizole may be observed, 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 co-administration of ergot alkaloids and macrolide antibiotics. There was one case of patient's lack of tolerance to ergotamine 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 may cause an increase in the level of cyclosporine in the blood plasma and the creation of nephrotoxic concentrations of cyclosporine in the blood. Plasma concentrations of cyclosporine should be regularly monitored. Vilprafen Solutab / digoxin: When josamycin and digoxin are co-administered, the level of the latter in the blood plasma may increase. 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 contraception.
special instructions
In patients with renal failure, treatment should be carried out taking into account the results of appropriate laboratory tests. The possibility of cross-resistance to different macrolide antibiotics should be considered (for example, microorganisms that are resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin).
Release form:
dispersible tablets 1000 mg. Standard packaging: 5 or 6 dispersible tablets in a blister made of polyvinyl chloride film and aluminum foil. 2 blisters along with instructions for use in a cardboard box.
Best before date:
2 years Vilprafen Solutab should not be used after the expiration date indicated on the package.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep the medicine out of the reach of children!
Conditions for dispensing from pharmacies
Dispensed with a doctor's prescription
