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

Registration number:

Trade name: VILPRAFEN SOLUTAB

International Nonproprietary Name (INN): Josamycin

Dosage form: dispersible tablets

Composition for 1 tablet

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.

ATS 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, idium 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 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 diseases. Infections in ophthalmology Blepharitis, dacryocystitis.
Skin and soft tissue infections
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 2 times a day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 times a day + amoxicillin 1 g 2 times a day + josamycin 1 g 2 times a day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 times a day + amoxicillin 1 g 2 times a day + josamycin 1 g 2 times 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.

Impact on the ability to drive vehicles and operate machinery
There was no effect of the drug on the ability to drive vehicles or operate machinery.

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 aid
In rare cases, dose-related transient hearing impairment has been reported.
Other: very rarely - candidiasis.

Overdose and other errors when taking

To date, there is no data on specific symptoms of poisoning. In case of overdose, 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 rather return to your normal treatment regimen. You should not take double the dose. A break in treatment or premature discontinuation of the drug will reduce the likelihood of treatment success.

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, there may be a slowdown in the elimination 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 following 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 administered together, josamycin and digoxin may increase the level of the latter in the blood plasma.
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 Packing:
5 or 6 tablets dispersible 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

List B.
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

Registration applicant (RU owner)

Astllas Pharma Europe B.V., Elisabethof 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.r.L., Italy
Issue 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, village Severnoe, Mr. Kharitonovo.

Send claims to the Moscow Representative Office of Astellas
Pharma Yuroy B.V. at:
109147 Moscow, Marksistskaya st. 16,
"Mosalarco Plaza-1" business center,

Vilprafen Solutab

International nonproprietary 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 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.

ATX 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, idium 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)

Chlamydia, mycoplasma (including ureaplasma) and mixed infections

Directions for use and doses

Vilprafen Solutab dispersible tablets can be taken in two different ways: they 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 mixed thoroughly.

Recommended daily dose for adults and teenagers aged over 14 years old ranges 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 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 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, Quincke's edema, toxic epidermal necrolysis, anaphylactic reactions

- liver dysfunction and jaundice are typically characterized by, but are not limited to, cholestatic reactions associated with mild renal failure

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, 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 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, there may be a slowdown in the elimination 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 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 following 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.

Vilprafen Solutab / triazolam

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

Vilprafen Solutab / bromocriptine

Josamycin may increase the effect of bromocriptine mesylate and cause drowsiness, dizziness, and ataxia. When using 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 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 after a medical assessment of the benefits/risks.

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 and 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

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

Registration Certificate Holder

Astellas Pharma Europe B.V., Netherlands

Silviusweg 62, 2333 BE Leiden, The Netherlands

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

Representative office of Astellas Pharma Europe B.V. in the Republic of Kazakhstan

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

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

Vilprafen Solutab

International nonproprietary 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 silicon dioxide, strawberry flavor 052311 AR 0551, magnesium stearate.

Description

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 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)

Chlamydia, mycoplasma (including ureaplasma) and mixed infections

Directions for use and doses

Daily dose for children from 5 to 14 years old is prescribed based on the calculation of 40 - 50 mg/kg 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 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, Quincke's edema, toxic epidermal necrolysis, anaphylactic reactions

- liver dysfunction and jaundice are typically characterized by, but are not limited to, cholestatic reactions associated with mild renal failure

Contraindications

hypersensitivity to macrolide antibiotics and other components of the drug

severe liver dysfunction

Drug interactions

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

When Vilprafen Solutab and digoxin are co-administered, the level of the latter in the blood plasma may increase.

Vilprafen Solutab / hormonal contraceptives

Vilprafen Solutab / triazolam

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

Vilprafen Solutab / bromocriptine

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 after a medical assessment of the benefits/risks.

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 and 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

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

Registration Certificate Holder

Astellas Pharma Europe B.V., Netherlands

Silviusweg 62, 2333 BE Leiden, The Netherlands

Representative office of Astellas Pharma Europe B.V. in the Republic of Kazakhstan

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

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

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Vilprafen solutab are dispersible tablets that belong to the macrolide class of antibacterial agents. This original drug is produced by the Italian company Montepharmaco 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 mark to divide the drug into equal parts. On one side of the tablet surface there is the inscription “IOSA”, and on the other - 1000, which corresponds to the amount of the active substance josamycin.

The drug is packaged in blisters of 5 cells and sold in a cardboard pack of 5 or 10 tablets. The active component is included in Vilprofen Solutab 1000 mg in the form of a salt - josamycin propionate. The excipients in the tablet are microcrystalline cellulose, weakly substituted hydroxypropylcellulose, sodium docusate, aerosil, aspartame (E951), magnesium stearate, strawberry flavor.

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

Vilprafen solutab 1000 photos

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

An important feature of the drug is its ability to affect intracellular forms of microorganisms.

What does Vilprafen solutab help with?

Microorganisms that are sensitive to the drug include various types of staphylococci (including those producing beta-lactamase), streptococci of various types, anthrax bacilli, corynebacteria diphtheria, gonococci, meningococci, shigella, Haemophilus influenzae, pertussis, legionella, mycoplasma, chlamydia, treponema (pathogens syphilis), rickettsia, some anaerobic bacteria and fungi (Peptococcus spp, Bacteroides spp, Peptostreptococcus spp.).

Based on such great therapeutic activity, we can answer the question of what Vilprafen Solutab helps with:

Infectious diseases of the respiratory system and ENT organs (gingitis, sinusitis, otitis media, laryngitis, pharyngitis, bronchitis, pneumonia, whooping cough, psittacosis);
Diseases of the urinary and reproductive organs of infectious origin: prostatitis, gonorrhea, urethritis, chlamydia, syphilis, mycoplasmosis, ureaplasmosis;
Bacterial skin lesions: pyoderma, acne, furunculosis, lymphadenitis, erysipelas, anthrax;
Eye diseases (inflammation in the eyelids or nasolacrimal duct 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 respiratory tract infections, 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 loss of reproductive function, miscarriages and intrauterine infection of the fetus. Josamycin has far fewer side effects than other antibiotics and is less likely to cause the development of 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 3g, they are divided into 2-3 doses per day. Typically, therapy is carried out at a rate of 1.5-2 g of josamycin per day.

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

For body weights over 40 kg, the drug is taken in an adult dosage.

Special instructions

Taking Vilprafen Solutab may affect the effect of certain medications:

Taking this macrolide with some antiallergic drugs (terfenadine, astemizole) leads to life-threatening arrhythmias.
Slowing the elimination of xanthines while taking josamycin can lead to theophylline intoxication.
With the combined use of Vilprafen 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 in any way.

Side effects of Vilprafen Solutab, contraindications

The most common side effects are abdominal pain, nausea and allergies (hives and other skin reactions). Constipation, diarrhea, problems with appetite, and vomiting are much less common. There is a possibility of developing pseudomembranous colitis. Manifestations of liver dysfunction and jaundice are possible. Taking excessive 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;
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 from the doctor. No cases of drug overdose have been reported so far, so there is no specific antidote and symptomatic treatment is expected along with detoxification therapy.

Analogues of Vilprafen Solutab, list of drugs

Today, among 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 ensures better bioavailability of the active component. 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 “reabsorption window” - 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 starting from 1 year. In addition, the cost of treatment with Vilprafen Solutab is approximately 30% cheaper than just Vilprafen. Thus, we can say with confidence 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 convenient to take, has few side effects and a low likelihood of the emergence of 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: complete 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. Would you like to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Antibiotic of the macrolide group.

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription.

Prices

How much does Vilprafen cost? The average price in pharmacies is 600 rubles.

Release form and composition

The drug Vilprafen is available in the form of tablets for oral administration in cardboard packaging in blisters of 10 pieces. Each tablet is coated with a white film coating 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, hydroxypropylmethylcellulose, 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 fixation of transport RNA, and also blocks the translocation of A-center peptides (a type of mutation that is accompanied by chromosomal rearrangement that affects the properties of the cell) and inhibits the intracellular production of proteins from amino acids.

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

The substance is active against gram-positive aerobic microorganisms, including:

Peptococci secreted by the body during inflammatory processes;
Peptostreptococci, which provoke the development of mixed infections;
Staphylococcus;
The causative agent of anthrax is anthrax bacillus;
Bacteria of the genus Corynebacterium, which are the causative agents of diphtheria;
Clostridium perfringens – causative agents of gas gangrene and toxic infections in humans;
Streptococci.

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

Hemophilus, which is the cause of hemophilus 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 causative agents of purulent-infectious diseases that develop after injuries, surgical interventions, 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;
, lymphogranuloma venereum, (with hypersensitivity to penicillin);
Infections of the ENT organs and upper respiratory tract, including paratonsillitis and;
Lower respiratory tract infections, 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.

Contraindications

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

Use during pregnancy and lactation

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

Instructions for use

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

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

The bottle of suspension must be shaken before use.

Side effects

If the drug is used correctly and the dosage specified in the instructions is strictly followed, Vilprafen is well tolerated by patients, however, in some cases the following side effects may develop:

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

Overdose

To date, no cases of overdose have been registered with this drug. In case of overdose after taking the drug, one should expect increased side effects and implement symptomatic therapy.

Special instructions

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

The possibility of cross-resistance to various macrolide antibiotics should be taken into account (for example, microorganisms that are resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin).

Drug interactions

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 may reduce their effectiveness.
Concomitant use of an antibiotic with cyclosporine may lead to an increase in the concentration of the latter, so its level should be monitored throughout 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 combined use of Vilprafen with antihistamines, including astemizole and terfenadine, increases the concentration of the latter, which can lead to the development of serious cardiac arrhythmias that are life-threatening.