Vilprafen is an antibiotic wide range action, part of the group of macrolides. Its active substance is josamycin, which inhibits and destroys bacteria. The drug is not prescribed to premature babies. Vilprafen in liquid form can be taken by newborns and older children only after accurate weighing. After 14 years of age, antibiotics are prescribed in the same dosages as for adults.

Wilprafen: release form

The medication is available in solid and liquid form:

white oblong coated tablets contain 500 mg of josamycin;
sweet and aromatic soluble tablets Vilprafen Solutab contain 1000 mg active substance;
suspension - a liquid preparation in dark bottles, for every 10 ml of which there is 300 mg of josamycin;
suppositories with josamycin.

The auxiliary ingredients of the medicine are magnesium stearate, microcrystalline cellulose, aluminum hydroxide, titanium dioxide, colloidal anhydrous silica.

Indications for use of Vilprafen

The instructions included with it do not recommend self-treatment with Vilprafen. Parents should consult a doctor and understand the intricacies of using the drug.

Indications for use, the instructions for Vilprafen disclose a number of pathologies that are often found in children:

infectious diseases occurring with inflammatory processes;
infections of the ENT organs and upper respiratory tract(tonsillitis, otitis media, sinusitis, tonsillitis, laryngitis, pharyngitis);
lower respiratory tract infections (whooping cough, pneumonia, bronchopneumonia, acute bronchitis);
infections of the skin and soft tissues (phlegmon, pyoderma, lymphadenitis, furunculosis, erysipelas);
infection genitourinary system(pyelonephritis, mycoplasmosis, epididymitis, ureaplasma, urethritis, chlamydia);
infectious lesions of the oral cavity (stomatitis, gingivitis, alveolitis, periodontal disease).

In pediatrics, Vilprafen is also prescribed to treat children from diphtheria and scarlet fever if their body is hypersensitive to penicillin. Instructions for use of the antibiotic Wilprafen state that the drug is good for gastrointestinal diseases caused by damage to the tract by the bacterium Helicobacter pylori.

How to be treated with Vilprafen: instructions

To improve the condition of infected children, Vilprafen is used in the form of diluted tablets of the Solutab variety or immediately purchased in a liquid form called a suspension. Premature babies are not treated with this antibiotic; other patients weighing less than 10 kg are prescribed the drug in extreme cases.

How to give Vilprafen correctly small child? The printed instructions for use suggest that pediatricians and parents be guided by the exact weight of the baby:

body weight up to 10 kg – dosage 40 – 50 mg/kg divided into 2 – 3 doses;
weight 10 - 20 kg - dissolve half or a quarter of the tablet in water and give the child 2 p. in a day;
with a weight of 20 - 40 kg, Vilprafen is given to children a whole tablet or half (1000 and 500 mg, respectively) twice a day;
with a body weight of more than 40 kg, 1 whole tablet should be taken 2 times. per day.

If Wilprafen Solutab was purchased by parents, the instructions for use prescribe treatment with an antibiotic in two ways. If the child is able to swallow the tablet, it is given whole or crushed and asked to be washed down with water. Children under one year of age are given a homemade suspension obtained by dissolving the tablet in a small amount of water.

Parents often ask when it is better to give Vilprafen to the patient - before or after meals. In this regard, the instructions state that the medication is more effective when taken between main feedings.

Contraindications and possible side effects

Before agreeing to treatment with Vilprafen, you need to understand what contraindications exist for its use. Prematurity has already been mentioned. Other categories of patients who should not be prescribed Vilprafen are:

with an allergy to macrolide antibiotics;
characterized by hypersensitivity to josamycin and additional components of the drug;
having liver pathologies that disrupt the functionality of the organ and the functioning of the biliary system.

Vilprafen has many side effects, but this does not mean that they will necessarily appear in the child. Digestive system may react to the antibiotic with nausea, heartburn, vomiting, poor appetite, diarrhea, or constipation. From the liver and biliary tract, cases of increased activity of liver enzymes in the blood, jaundice and impaired bile outflow were recorded.

Allergic reactions included urticarial rashes, angioedema, bullous dermatitis, erythema and Stevens-Johnson syndrome. Rare phenomena include hearing problems, thrush, and capillary hemorrhages in the skin.

If treatment with Vilprafen does not produce results, or the drug is not suitable for a particular patient at all, drugs of a similar effect are prescribed instead, since this antibiotic has no structural analogues.

Drugs replacing Wilprafen:

Suprax;
Azithromycin;
Amoxiclav;
Clarithromycin;
Midecamycin;
Sumamed;
Erythromycin;
Spiramycin.

The macrolide antibiotic is Vilprafen. Instructions for use indicate that tablets 500 mg and 1000 mg Solutab have bactericidal and bacteriostatic properties. According to doctors, this drug helps in the treatment of ureaplasmosis, chlamydia, bronchitis, pneumonia and other infections.

Release form and composition

The drug is available in the form of film-coated tablets. The blister pack contains 10 such tablets. The packaging is placed in a cardboard box.

The drug is also available in the form of a suspension. Contained in dark glass bottles, 100 ml per bottle. The kit includes a measuring cup.

The composition of Vilprafen is as follows:

one tablet contains 500 mg of josamycin or 1000 mg (Vilprafen Solutab);
suspension (10 ml) contains 300 mg of josamycin.

Indications for use

What does Vilprafen (Solutab) help with? Tablets are prescribed:

People with hypersensitivity to penicillin for scarlet fever.
Infectious diseases that provoke inflammatory processes that were caused by microorganisms with high sensitivity to the drug.
Infections skin and soft tissues (for boils, pyoderma, lymphadenitis, etc.)
It is used in the treatment of diphtheria in addition to diphtheria antitoxin therapy.
Infections of the oral cavity (for periodontal diseases, gingivitis).
Infectious diseases of the ENT organs and upper respiratory tract (used for sore throat, pharyngitis, tonsillitis, sinusitis, laryngitis, otitis media).
Lower respiratory tract infections (pneumonia, acute bronchitis, whooping cough, bronchopneumonia).
Infections of the genitourinary organs (chlamydia, ureaplasma, gonorrhea, urethritis, prostatitis, etc.)

Instructions for use

Vilprafen is taken in the recommended daily dose for adults and adolescents over 14 years of age, which is 1-2 g, in 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.

Daily dose for children weighing at least 10 kg, it is prescribed based on the calculation of 40-50 mg/kg body weight daily, divided into 2-3 doses:

children weighing 10-20 kg are prescribed 250-500 mg (1/4-1/2 tablet dissolved in water) 2 times a day;
children weighing 20-40 kg are prescribed 500-1000 mg (1/2-1 tablet dissolved in water) 2 times a day;
children weighing more than 40 kg - 1000 mg (1 tablet) 2 times a day.

Typically, the duration of treatment is determined by the doctor and ranges from 5 to 21 days, depending on the nature and severity of the infection. In accordance with WHO recommendations, the duration of treatment for streptococcal tonsillitis should be at least 10 days.

In anti-Helicobacter therapy regimens, Vilprafen is prescribed in a dose of 1 g 2 times a day for 7-14 days in combination with other drugs in their standard doses:

famotidine 40 mg per day or ranitidine 150 mg 2 times a day + josamycin 1 g 2 times a 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 + tripotassium bismuth dicitrate 240 mg 2 times a day;
famotidine 40 mg per day + furazolidone 100 mg 2 times a day + josamycin 1 g 2 times a day + tripotassium bismuth dicitrate 240 mg 2 times 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 dicitrate 240 mg 2 times a day.

The instructions for Vilprafen Solutab provide that the drug can be taken in different ways: you can take the tablet with water, or before dissolving it in 20 ml of water. The suspension that forms after dissolving the tablet must be mixed very thoroughly.

Vilprafen tablets must be swallowed whole. Often patients are interested in how to take it, before or after meals. The instructions indicate that the tablets must be swallowed between main meals.

When treating, it should be taken into account that if one dose is missed, you must immediately take a dose of the drug. However, if it is time for your next dose, do not take the missed dose and return to your normal treatment regimen. Do not take double dose. A break in treatment or premature discontinuation of the drug reduces the likelihood of success of therapy.

pharmachologic effect

The drug is an antibiotic that belongs to the group of macrolites. The bacteriostatic effect of the drug is due to the inhibition of protein synthesis by bacteria. If there are foci of inflammation, the drug has a bactericidal effect.

Vilprafen is a highly effective agent against such intracellular microorganisms as Mycoplasma pneumoniae, Ureaplasma urealyticum, Chlamydia trachomatis, Legionella pneumophila, Chlamydia pneumonuae, Mycoplasma hominis.

High activity is also observed against gram-negative aerobic bacteria:

Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Bordetella pertussis;
gram-positive aerobic bacteria: Streptococcus pyogenes, Staphylococcus aureus, Corynebacterium diphtheriae, Streptococcus pneumoniae;
anaerobic bacteria: Peptostreptococcus, Peptococcus, Clostridium perfringens.

The drug is effective against Treponema pallidum. The active ingredient of the drug is josamycin, which is completely and rapidly absorbed from gastrointestinal tract.

Contraindications

The drug Vilprafen is contraindicated in patients with the following conditions:

Liver failure.
Individual intolerance to the constituent components of the drug.
Past severe allergic reactions for drugs from the macrolide group.
Pregnancy and breastfeeding period.

Side effects

While taking Vilprafen, it is possible to develop disorders from various systems body:

In case of severe persistent diarrhea, you need to keep in mind the possibility of developing pseudomembranous colitis (which is life-threatening) due to the action of the antibiotic.
Hypersensitivity reactions: in in some cases– allergic skin reactions (for example, urticaria).
Gastrointestinal tract: rarely - heartburn, nausea, loss of appetite, diarrhea and vomiting.
Hearing aid: in rare cases - dose-dependent transient disturbances hearing
Biliary tract and liver: in some cases - a transient increase in the activity of liver enzymes in the blood plasma, sometimes accompanied by jaundice and impaired bile outflow.

Children, pregnancy and breastfeeding

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

In childhood

The drug is not prescribed to premature babies. In newborn patients with impaired liver function, treatment is carried out under strict supervision.

Vilprafen is used in the form of a suspension for children under 14 years of age.

Vilprafen 1000 mg Solutab can be dissolved in water to prepare a suspension. If treatment with the drug is prescribed to children, the dosage is as follows: 30-50 mg per 1 kg of body weight, divided into three doses.

The suspension for children up to three months of age is dosed according to the exact weight of the child. Why tablets are used and whether they are worth using for treatment should be found out from your doctor.

special instructions

When Vilprafen is administered concomitantly with ergot alkaloids, vasoconstriction may increase. Therefore, in this case, careful monitoring of the patient’s condition is necessary.

The simultaneous use of josamycin and cyclosporine provokes an increase in the level of cyclosporine in the blood plasma. Nephrotoxic concentrations of cyclosporine are also observed in the blood. With this treatment, it is necessary to ensure constant monitoring of plasma concentrations of cyclosporine.

Drug interactions

If Vilprafen is prescribed simultaneously with antihistamines, which contain terfenadine or astemizole, sometimes the process of eliminating these substances slows down, which ultimately leads to the manifestation of cardiac arrhythmias, which are life-threatening.

If Vilprafen and Digoxin are taken simultaneously, the level of digoxin in the blood plasma may increase.

Speaking about interactions with other drugs, it should be borne in mind that Vilprafen is an antibiotic. Before using any medicine It is imperative to determine whether it is an antibiotic or not.

When taken with hormonal contraceptives, the effect of the latter may be reduced. In such a situation, the use of additional non-hormonal contraceptives is recommended.

If pseudomembranous colitis develops, Vilprafen should be discontinued and appropriate treatment prescribed. Taking drugs that reduce intestinal motility is contraindicated. Patients with renal failure it is necessary to adjust the dosage regimen in accordance with the values of creatinine clearance (CC).

According to the instructions, Vilprafen is not prescribed to premature babies. When used in newborns, liver function should be monitored. It is necessary to take into account the possibility of cross-resistance to various macrolide antibiotics.

Analogues of the drug Vilprafen

Analogues are determined by structure:

Vilprafen solutab.
Josamycin.

Analogues that belong to the group of macrolides have a similar effect:

Roxithromycin.
Spiramycin.

Patients often wonder how Vilprafen differs from Vilprafen Solutab. The difference between these drugs is explained by their release form.

Vilprafen are ordinary film-coated tablets. Solutab are soluble tablets that have a sweet taste and fruity aroma. They can be taken either in tablet form or as a suspension.

Vilprafen and Vilprafen Solutab are antibiotics belonging to the group of macrolides, the antimicrobial effect of which is caused by a violation of protein synthesis on the ribosomes of the microbial cell. Like other macrolides, they exhibit a post-antibiotic effect against gram-positive cocci, and also have immunomodulatory and moderate anti-inflammatory activity.

Josamycin is used as the active ingredient of the drugs.

Release form and composition

Vilprafen is available:

In the form of tablets, each containing 500 mg of josamycin. The tablets are film-coated in white or a similar color, have an oblong shape, convex edges and cuts in the middle;
In the form of a suspension for oral administration. One measuring cup with a capacity of 10 ml contains 300 mg of josamycin. A suspension is a viscous liquid white with a pronounced fruity aroma and without sediment.

Vilprafen Solutab is available in the form of soluble fast acting tablets, the color of which can vary from white to yellowish. The tablets have an oblong shape, a sweet taste and a distinct strawberry smell. Each contains 1000 mg of josamycin in the form of josamycin propionate.

Pharmacological properties

Vilprafen and Vilprafen Solutab are broad-spectrum antibiotics and are used as antibacterial agent for systemic treatment.

Bactericidal effect active substance The drug is due to the fact that josamycin is able to bind to the large subunit of the ribosomal membrane (50S), prevents transfer RNA from being fixed, 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 suppresses intracellular protein production 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:

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

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

Neisseria, which are the causative agents of diseases such as gonorrhea and meningitis;
Some varieties of Shigella, which provokes the development of dysentery;
Hemophilus, which is the cause of hemophilus influenzae infections, including purulent meningitis, acute pneumonia, pericarditis, septicemia, etc.;
Bacteroides fragilis, which are causative agents of purulent-infectious diseases that develop after injuries, surgical interventions, with immunodeficiency, etc.;

According to reviews of Vilprafen, resistance to its constituent josamycin develops much less frequently than to other antibiotics that belong to the macrolide group.

Medical reviews of Vilprafen indicate that after oral administration, the drug is well and quickly absorbed from the gastrointestinal tract. In this case, the maximum concentration of josamycin in the blood plasma is observed after 1-4 hours. Approximately 15% of the active substance is bound to plasma proteins, and its highest concentration is found in the lungs, tonsils, salivary fluid, secretion of the sweat and lacrimal glands.

Biotransformation of josamycin occurs in the liver. As a result of this process, metabolites with less activity are formed, which are excreted from the body mainly through bile and approximately 20% through the kidneys and urine.

Indications for use

Prescribing Vilprafen, according to the instructions, is advisable for the treatment of acute and chronic form infectious and inflammatory diseases caused by the activity of microorganisms sensitive to the action of josamycin, namely:

Infectious diseases affecting the upper and lower respiratory tract, ENT organs, oral cavity, soft fabrics and skin, reproductive and urinary systems;
Diphtheria;
Scarlet fever;
Infectious diseases caused by chlamydia and mycoplasma;
Mixed infections affecting the genitals and urinary tract.

Contraindications

Vilprafen's instructions list a number of contraindications for its use. Among them:

Individual intolerance to drugs belonging to the pharmacological group of macrolides;
Severe liver dysfunction;
Prematurity.

The medication is prescribed with caution if the patient is diagnosed with renal failure.

It is forbidden to give antibiotics to children weighing up to 10 kg.

Use during pregnancy

Vilprafen is prescribed during pregnancy and breastfeeding if the benefits to the mother outweigh the potential risks to the child.

Directions for use and dosage

The drug in tablets and suspension form is intended for oral administration. It is recommended to swallow the tablets without chewing and with a small amount of liquid. Vilprafen Solutab soluble tablets are diluted in at least 20 ml of liquid before use; they can also be swallowed with water.

The daily dose of the drug for adults and children over 14 years of age is 1-2 g, which is recommended to be divided into three doses, with the first dose not being less than 1 g.

The suspension is prescribed mainly to children under 14 years of age. The daily dose depends on the age and weight of the patient. According to the instructions for Vilprafen, it is calculated according to the following scheme: 30-50 mg per kilogram of body weight. The frequency of doses is 3. It is recommended to shake it before use.

It is important:

For children under three months of age, the dose must be calculated very accurately depending on weight.
Course of therapy for diseases caused by streptococcal infection, should not be less than 10 days.

Catad_pgroup Antibiotics macrolides and azalides

Vilprafen - instructions for use

International nonproprietary name: josamycin

Dosage form: film-coated tablets

Composition for 1 tablet
Active Ingredients
Josamycin - 500 mg
Auxiliary ingredients up to tablet weight 640 mg
microcrystalline cellulose - 101.0 mg, polysorbate 80 - 5.0 mg, colloidal silicon dioxide - 14.0 mg, carmellose sodium - 10.0 mg, magnesium stearate - 5.0 mg, methylcellulose - 0.12825 mg, polyethylene glycol 6000 - 0.3846 mg, talc - 2.0513 mg, titanium dioxide - 0.641 mg, aluminum hydroxide - 0.641 mg, copolymer of methacrylic acid and its esters - 1.15385 mg

Description
White or almost white, film-coated tablets, oblong, biconvex, scored on both sides.

Pharmacotherapeutic group: antibiotic, macrolide.

ATX Code: J01FA07

Pharmacological properties

Pharmacodynamics.
Antibacterial drug from the group of macrolides. The mechanism of action is associated with disruption of protein synthesis in the microbial cell due to reversible binding to the 50S ribosomal subunit. In therapeutic concentrations, as a rule, it has a bacteriostatic effect, slowing down the growth and reproduction of bacteria. When high concentrations are created at the site of inflammation, it has a bactericidal effect.

Josamycin is active against gram-positive bacteria ( Staphylococcus spp.., incl. methicillin-sensitive strains Staphylococcus aureus), Streptococcus spp., incl. Streptococcus pyogenes and S treptococcus pneumoniae, Corynebacterium diphtheriae, Listeria monocytogenes, Propionibacterium acnes, Bacillus anthracis, Clostridium spp. Peptococcus spp., Peptostreptococcus spp.), gram-negative bacteria ( Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Bordetella spp. Brucella spp., Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni), sensitivity Bacteroides fragilis may be variable) Chlamydia spp. incl. S. trachomatis, Chlamydophila spp., incl. Chlamydophila pneumoniae(previously called Chlamydia pneumoniae), Mycoplasma spp.., incl. Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma spp. Treponema pallidum, Borrelia burgdorferi.

As a rule, it is not active against enterobacteria, therefore it has little effect on the microflora of the gastrointestinal tract. Retains activity in case of resistance to erythromycin and other 14- and 15-membered macrolides. Resistance to josamycin is less common than to 14- and 15-membered macrolides.

Pharmacokinetics.
After oral administration, josamycin is rapidly absorbed from the gastrointestinal tract; food intake does not affect bioavailability. The maximum plasma concentration of josamycin is achieved 1 hour after administration. When taken at a dose of 1 g, the maximum concentration in blood plasma is 2-3 mcg/ml. About 15% of josamycin is bound to plasma proteins. Josamycin is well distributed in organs and tissues (with the exception of the brain), creating concentrations exceeding plasma levels and remaining at therapeutic levels. long time. Josamycin creates especially high concentrations in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. 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. The half-life of the drug is 1-2 hours, but may be prolonged in patients with impaired liver function. Excretion of the drug by the kidneys does not exceed 10%.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Infections of the upper respiratory tract and ENT organs:
tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), scarlet fever (in case of hypersensitivity to penicillin).

Lower respiratory tract infections:
acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, including those caused by atypical pathogens, whooping cough, psittacosis.

Infections in dentistry:
gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess.

Infections in ophthalmology:
blepharitis, dacryocystitis

Skin and soft tissue infections:
folliculitis, boil, furunculosis, abscess, anthrax, erysipelas, acne, lymphangitis, lymphadenitis, phlegmon, panaritium, wound (including postoperative) and burn infections.

Infections of the genitourinary system:
urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and/or mycoplasma, gonorrhea, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum.

Gastrointestinal diseases associated with H. pylori
Peptic ulcer stomach and duodenum, chronic gastritis and etc.

Contraindications

hypersensitivity to josamycin and other components of the drug
hypersensitivity to other macrolides;
severe liver dysfunction:
children weighing less than 10 kg.

Pregnancy and lactation
Allowed for use during pregnancy and during breastfeeding after a medical assessment of the benefit/risk. 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 the age of 14 years is from 1 to 2 g of josamycin, the standard dose is 500 mg x 3 times per day. The daily dose should be divided into 2-3 doses. If necessary, the dose can be increased to 3 g per day.

Typically, the duration of treatment is determined by the doctor, ranging from 5 to 21 days, depending on the nature and severity of the infection. In accordance with WHO recommendations, the duration of treatment for streptococcal tonsillitis 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 + bismuth tripotassium dicitrate 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.

Side effect

Adverse reactions are listed according to the frequency of their registration in accordance with the following gradation: very often: from >1/10, often: from >1/100 to< 1/10, нечасто: от >1/1000 to< 1/100, редко: от >1/10 LLC up to<1/1000, очень редко от <1/10 000.

From the gastrointestinal tract
Often - stomach discomfort, nausea
Uncommon: abdominal discomfort, vomiting, diarrhea
Rarely - stomatitis, constipation, loss of appetite
Very rarely - pseudomembranous colitis

Hypersensitivity reactions:
Rarely - urticaria, angioedema and anaphylactoid reaction.
Very rarely - bullous dermatitis, exudative erythema multiforme, incl. Steven-Johnson syndrome.

From the liver and biliary tract:
Very rarely - liver dysfunction, jaundice

From the senses:
In rare cases, dose-related, transient hearing impairment has been reported
Other: very rarely - purpura

Overdose and other errors when taking
To date, there is no data on specific symptoms of overdose. In case of overdose, the symptoms described in the “Side Effects” section should be expected, especially from the gastrointestinal tract.

Interaction with other drugs

Other antibiotics
Since bacteriostatic antibiotics in vitro can reduce the antimicrobial effect of bactericidal ones, their coadministration should be avoided. Josamycin should not be prescribed together with lincosamides, as a mutual decrease in their effectiveness is possible.

Xanthines
Some representatives of the macrolide group slow down the elimination of xanthines (theophylline), which can lead to signs of intoxication. Clinical and experimental studies indicate that josamycin has less effect on the elimination of theophylline than other macrolides.

Antihistamines
When josamycin is co-administered with antihistamines containing terfenadine or astemizole, the risk of life-threatening arrhythmias may increase.

Ergot alkaloids
There are isolated reports of increased vasoconstriction after co-administration of ergot alkaloids and macrolide antibiotics, including a single observation while taking josamycin.

Cyclosporine
Co-administration of josamycin and cyclosporine may cause increased plasma levels of cyclosporine and increase the risk of nephrotoxicity. Plasma concentrations of cyclosporine should be regularly monitored.

Digoxin
When administered together, josamycin and digoxin may increase the level of the latter in the blood plasma.

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

In patients with renal failure, treatment should be carried out taking into account the results of appropriate laboratory tests (determination of endogenous creatinine clearance).

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

Impact on the ability to drive vehicles and operate machinery
There was no effect of the drug on the ability to drive vehicles.
means and work with mechanisms.

Release form
Film-coated tablets 500 mg.
10 tablets in an aluminum/PVC blister. 1 blister along with instructions for use is placed in a cardboard box.

Best before date
4 years.
Vilprafen should not be used after the expiration date indicated on the package.

Storage conditions
Store at a temperature not exceeding 25 ° C in a place protected from light.
Keep the medicine out of the reach of children!

Conditions for dispensing from pharmacies
Dispensed with a doctor's prescription

Registration applicant (RU owner)
Astellas Pharma Europe B.V., Elisabethof 19, 2353 EB Leiderdorp, The Netherlands /
AstellasPharmaEuropeB.V., Elisabethhof 19, 2353 EWLeiderdorp, TheNetherlands.

Manufacturer

Via Galilei, n.7, 20016 Reiu (MI), Italia

Packer (primary packaging)
Montefarmaco S.p.A., Italy
or ZAO ORTAT, Russia

Packer (secondary/tertiary packaging)
Montefarmaco S.p.A., Italy
or Temmler Italia C.p.JL, Italy
or ZAO ORTAT, Russia

Issue quality control
Temmler Italia S.r.L., Italy
or ZAO ORTAT, Russia

Subject to packaging at ORTAT CJSC
Manufacturer
Montefarmaco S.p.A., Italy/Montefarmaco S.p.A.
Via Galilei, n.7, 20016 Pero (MI), Italy

Packer and release control
ZAO ORTAT, Russia
157092, Kostroma region, Susaninsky district, village. Severnoe, Mr. Kharitonovo.

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

Excipients: microcrystalline cellulose, polysorbate 80, precipitated silicon oxide, sodium carboxymethylcellulose, magnesium stearate.

Shell composition: methylcellulose, polyethylene glycol 6000, talc, titanium dioxide, aluminum hydroxide, copolymer of methacrylic acid and its esters.

10 pieces. - blisters (1) - cardboard packs.

Clinical and pharmacological group

Macrolide antibiotic

pharmachologic effect

Antibiotic of the macrolide group. It has a bacteriostatic effect due to inhibition of bacterial protein synthesis. When high concentrations are created at the site of inflammation, it has a bactericidal effect.

Highly active against intracellular microorganisms: Chlamydia trachomatis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila; gram-positive bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Corynebacterium diphtheriae; gram-negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis; anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Clostridium 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

Suction

After oral administration, josamycin is quickly and completely absorbed from the gastrointestinal tract. Food intake does not affect bioavailability. Cmax is reached 1-2 hours after administration.

Distribution

Plasma protein binding does not exceed 15%.

Particularly high concentrations are determined in the lungs, tonsils, saliva, sweat and tear fluid. The concentration of josamycin in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Penetrates the placental barrier and is excreted in breast milk.

Metabolism

Josamycin is metabolized in the liver to less active metabolites.

Removal

Excreted mainly in bile, excretion in urine is less than 20%.

Indications for use of the drug

Acute and chronic infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

- infections of the upper respiratory tract and ENT organs (including tonsillitis, pharyngitis, tonsillitis, paratonsillitis, otitis media, sinusitis, laryngitis);

- diphtheria (in addition to treatment with diphtheria antitoxin);

- scarlet fever (with hypersensitivity to penicillin);

— infections of the lower respiratory tract (including acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);

- whooping cough;

- psittacosis;

— gingivitis and periodontal diseases;

- blepharitis, dacryocystitis;

— infections of the skin and soft tissues (including pyoderma, furunculosis, acne, lymphangitis, lymphadenitis);

- anthrax;

- erysipelas (with hypersensitivity to penicillin);

— lymphogranuloma venereum;

- infections of the urinary tract and genital organs (including urethritis, prostatitis, gonorrhea, syphilis / with hypersensitivity to penicillin /, chlamydial, mycoplasma / including ureaplasma / and mixed infections).

Dosage regimen

At acne vulgaris and globular acne Prescribe 500 mg 2 times a day for the first 2-4 weeks, then 500 mg 1 time a day as maintenance therapy for 8 weeks.

The tablets should be swallowed whole, without chewing, with a small amount of liquid.

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.

When taking Vilprafen, it should be taken into account that if one dose is missed, you must immediately take a dose of the drug. However, if it is time for your next dose, do not take the missed dose and return to your normal treatment regimen. Do not take double dose. A break in treatment or premature discontinuation of the drug reduces the likelihood of success of therapy.

Side effect

From the digestive system: rarely - lack of appetite, nausea, heartburn, vomiting, dysbacteriosis, diarrhea; in some cases - a transient increase in the activity of liver transaminases, impaired bile outflow and jaundice. If persistent severe diarrhea develops while taking the drug, one should keep in mind the possibility of developing pseudomembranous colitis.

On the part of the hearing organ: rarely - dose-dependent transient hearing impairment .

Allergic reactions: in isolated cases - urticaria.

Others: in some cases - candidiasis.

Contraindications to the use of the drug

- severe liver dysfunction;

- increased sensitivity to macrolide antibiotics.

Use of the drug during pregnancy and lactation

The use of Vilprafen is permitted during pregnancy and lactation (breastfeeding) according to indications.

Use for liver dysfunction

The drug is contraindicated in cases of severe liver dysfunction.

Use for renal impairment

special instructions

The drug should be prescribed to patients with renal failure with caution and under monitoring of renal function.

When prescribing Vilprafen, 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).

Overdose

To date, there is no data on the specific symptoms of an overdose of Vilprafen. In case of overdose, one should assume the occurrence and intensification of side effects from the digestive system.

Drug interactions

Bacteriostatic antibiotics may reduce the bactericidal effect of other antibiotics such as penicillins and cephalosporins. Therefore, simultaneous administration of Vilprafen with antibiotics of these groups should be avoided, for example, for infections such as meningitis and streptococcal tonsillopharyngitis.

When Vilprafen is used simultaneously with lincomycin, the effectiveness of both drugs may decrease (this combination should not be prescribed).

Some macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical experimental studies have shown that josamycin has a less pronounced effect on the elimination of theophylline than other macrolide antibiotics.

With the simultaneous use of Vilprafen and antihistamines containing terfenadine or astemizole, the elimination of the latter may be slowed down, which increases the risk of life-threatening arrhythmias.

There are isolated reports of increased vasoconstriction with the simultaneous use of macrolides and ergot alkaloids. There was one case of patient's lack of tolerance to ergotamine while taking josamycin. Given this, when using josamycin and ergotamine simultaneously, the patient's condition should be monitored.

With the simultaneous use of Vilprafen and cyclosporine, it is possible to increase the level of cyclosporine in the blood plasma and create its nephrotoxic concentration in the blood. Therefore, when using these drugs simultaneously, the concentration of cyclosporine in the blood plasma should be regularly monitored.

With the simultaneous use of josamycin and digoxin, an increase in the serum concentration of the latter is possible.

In rare cases, during treatment with macrolides, the contraceptive effect of hormonal contraceptives may not be effective enough (the use of non-hormonal methods of contraception may be required).

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life - 4 years.