The article will discuss reviews of “Vilprafen” 500 mg.
This is an antimicrobial drug that fights gram-positive and gram-negative bacteria, as well as infections caused by intracellular microorganisms. Doctors often prescribe Vilprafen 500 for the treatment of chlamydia infections. It was discovered a long time ago, but has not lost any of its relevance in the antibiotic market due to its composition, long-lasting therapeutic effect and the possibility of use in pregnant women, as well as children with early age, but weighing at least 10 kilograms.
Composition and release form
The active substance of this drug is josamycin.
The antibiotic is produced in the following form:
When is Vilprafen 500 prescribed?
An antibiotic is prescribed in the case of:
- tonsillitis, sinusitis, pharyngitis, otitis, bronchitis, pneumonia, laryngitis,
- diphtheria;
- scarlet fever (with negative reaction to penicillin);
- acute bronchitis, bronchopneumonia, pneumonia, whooping cough, psittacosis;
- inflammation in the oral cavity (gingivitis, periodontitis);
- burn infections;
- dacryocystitis, blepharitis;
- urethritis, prostatitis, gonorrhea;
- pyoderma, boils, anthrax, erysipelas, acne, lymphangitis, lymphadenitis;
- chlamydial, mycoplasma, ureaplasma infections;
- inflammation in the gastrointestinal tract caused by Helicobacter pylori. According to reviews, “Vilprafen Solutab 500” is very effective.
The diagnosis and prescription of this drug should be made only by the attending physician after taking the necessary tests. At his discretion and based on the results of the examination, a treatment plan is outlined. Taking “Vilprafen 500” per day is divided into two times, washed down with water, it is better to do this between meals. On average, the course lasts from three to five weeks. Reviews of Vilprafen 500 are mostly positive.
Contraindications for use
The drug should not be used:
- if available increased sensitivity to josamycin or any other component included in the composition;
- were allergic reactions for macrolide antibiotics;
- have liver disease;
- premature babies.
This must be taken into account before making an appointment.
Side effects
According to the instructions for use and reviews of “Vilprafen 500” for adults and children, the drug can provoke the following adverse reactions:
- discomfort in the stomach, nausea, vomiting;
- loss of appetite, diarrhea;
- stomatitis is not excluded;
- constipation, in addition pseudomembranous colitis, liver dysfunction;
- urticaria, bullous dermatitis, anaphylactoid reaction;
- purpura, as well as hearing loss of a transient nature.
If these symptoms occur, you should immediately consult a doctor.
Dosage for adults
This drug is prescribed only by a doctor, and the dosage must correspond to the diagnosis.
During treatment skin diseases you should take 0.5 g 2 times a day for 2-4 weeks, and then 0.5 g 1 time a day for eight weeks to consolidate the result.
For treatment streptococcal infections therapy lasts at least 10 days.
In the case of treatment of Helicobacter pylori, you should take 1 to 2 g of antibiotic per day for one to two weeks in combination with other drugs.
Pyoderma - 500 mg, course 10 days, 2 tablets per day.
Chronic periodontitis - 500 mg 2 times a day, course - 12-14 days.
Reviews of Vilprafen 500 for children should be read in advance.
For children
At the age of up to three months, taking into account a body weight of at least 10 kilograms, “Vilprafen 500” is prescribed at 40-50 mg per 1 kilogram of the child’s weight. And only after the daily weigh-in. The daily dose should be divided over the whole day.
If the baby’s weight is from 10 to 20 kg, the antibiotic is given 250-500 mg 2 times a day.
With a weight of 20 to 40 kg, drink the drug twice a day, 500-1000 mg.
Children weighing more than 40 kg are given 1000 mg twice a day.
According to reviews, Vilprafen 500 is well tolerated and safe during pregnancy.
During pregnancy and lactation
The use of antibiotics during pregnancy is acceptable. It is advisable to stop breastfeeding for the period of treatment, as the antibiotic penetrates into the milk. For treatment chlamydial infection Pregnant women are prescribed medication only if the risk to the mother and child has been assessed. Reviews from pregnant women about Vilprafen 500 are quite common and all of them are positive.
Interaction with alcohol
When taking an antibiotic, alcohol consumption should be avoided, as it may cause problems digestive system(nausea, vomiting, diarrhea), liver, development of pseudomembranous colitis.
During treatment with the drug, it is possible to drive a vehicle.
Existing analogues
Due to the fact that “Vilprafen 500” may not be suitable for all patients, analogues of this antibiotic are selected.
| Name | ||
| "Erythromycin" |
|
|
| "Clarithromycin" |
|
|
| "Flemoxin" |
| low disease coverage. |
| "Amoxiclav" |
|
|
| "Azithromycin" |
|
|
The above antibiotics have their advantages and disadvantages. But only a doctor should prescribe drugs for treatment.
Interaction with other drugs
Please note the following points:
- Please note that when taking Vilprafen 500 and bactericidal antibiotics simultaneously, their effectiveness decreases.
- When taking "Lincomycin" it decreases therapeutic effect both drugs.
- Reception antihistamines together with an antibiotic leads to arrhythmia.
- Antibiotics should be used with caution with cyclosporines, as this leads to an increase in the blood levels of the latter and has a negative effect on the kidneys. It is necessary to monitor cyclosporine levels in the blood as often as possible.
- Effect of taking birth control pills decreases, so during treatment it is better to use other non-hormonal methods of protection against unwanted pregnancy.
According to reviews, Vilprafen 500 is very effective, but it should be taken with great caution.
Treatment of ureaplasma
The constant presence of ureaplasma in the body is not typical for healthy person. These are bacteria without a cell membrane and DNA, slightly larger than viruses. Habitat: mucous membranes of the human genitourinary tract. Under certain circumstances, inflammation of the mucous membrane occurs. This infection is transmitted sexually, and if a woman was sick before pregnancy, then there is a high chance of infecting the newborn during childbirth. Therefore, doctors recommend that both sexual partners undergo treatment at the same time, and preferably before planning a pregnancy.
According to reviews, “Vilprafen 500” quickly helps with ureaplasma. It is the best in the fight against the microbe Ureaplasma urealyticum. Women are additionally prescribed medications to restore the flora of the intimate area. The course of treatment is at least 10 days, it consists of the following:
- Taking Vilprafen 500 should start with 0.5 g three times a day or 1 g twice a day. To maintain therapeutic concentrations, the antibiotic is used every 8-12 hours. If you miss taking a medicine, the dose is not increased.
- In addition to antibiotic therapy, women are given vaginal suppositories"Hexicon" before going to bed, men are recommended to rinse the urethra with a solution of "Hexicon". Additionally, women can use Vaginorma S or Ginolakta suppositories to restore the vaginal microflora.
- On the 1st and 5th day, women are recommended to take antifungal suppositories (“Polygynax”).
- To reduce the effect of the drug on the liver, use “Karsil” one capsule 3 times a day. "Vilprafen 500" does not have a strong effect on the gastrointestinal tract. But gastroenterologists recommend taking a course of probiotics, for example, Linex or Bifilax, together with antibiotics. This will only be beneficial.
Also, do not forget about taking multivitamin complexes and immunomodulators.
During treatment, it is better to completely give up smoking, alcohol, spices, salty and spicy foods. It is recommended to avoid sexual intercourse.
After 2 weeks after the course of treatment, it is necessary to be tested for the presence of the pathogen. Moreover, both partners undergo the examination.
1 tablet contains the active substance josamycin in an amount of 500 mg.
Auxiliary components in 1 tablet: polysorbate 80 – 5 mg; magnesium stearate – 5 mg; microcrystalline cellulose – 101 mg; colloidal silicon dioxide – 14 mg; carmellose sodium – 10 mg.
Shell composition: polyethylene glycol 6000 – 0.3846 mg; methylcellulose – 0.12825 mg; titanium dioxide – 0.641 mg; talc – 2.0513 mg; copolymer of methacrylic acid and its esters – 1.15385 mg; aluminum hydroxide – 0.641 mg.
Vilprafen is produced in the form of film-coated tablets - biconvex, oblong, almost white or white, with marks on both sides (10 pieces in blisters, 1 blister in a cardboard box).
Description of the dosage form
Antibiotic of the macrolide group.
Characteristic
Vilprafen is an antibiotic of the macrolide group with bactericidal action.
Pharmacokinetics
After oral administration, josamycin is absorbed from the gastrointestinal tract from high speed, food intake does not change its bioavailability. The maximum concentration of the substance in plasma is achieved 1 hour after administration. When taking Vilprafen in a dose of 1 g, the maximum level of its active substance in the blood plasma is 2-3 mcg/ml. The degree of binding of josamycin to plasma proteins is approximately 15%. The compound is well distributed in tissues and organs (excluding the brain), and its concentrations often exceed plasma levels and maintain therapeutic effectiveness for a long time. Particularly high concentrations of josamycin are determined in tear fluid, saliva, sweat, tonsils and lungs. Its content in sputum exceeds the content in plasma by 8-9 times.
Josamycin crosses the placental barrier and penetrates into breast milk. The compound is metabolized in the liver, forming metabolites with less pharmacological activity. Josamycin is excreted primarily in bile. Its half-life is 1–2 hours, but this may be prolonged in patients with liver dysfunction. The degree of excretion of the drug in urine does not exceed 10%.
Pharmacodynamics
The mechanism of action of josamycin is to inhibit protein production in the microbial cell, which is explained by reversible binding to the 50S ribosomal subunit. Usually in therapeutic concentrations for active component The drug is characterized by a bacteriostatic effect, which leads to inhibition of the growth and reproduction of bacteria. If high concentrations of josamycin are created in the inflammatory focus, manifestations of a bactericidal effect are observed.
Josamycin is active against the following microorganisms:
- gram-positive bacteria: Staphylococcus spp. (including methicillin-sensitive strains Staphylococcus aureus), Peptostreptococcus spp., Streptococcus spp. (including Streptococcus pneumoniae and Streptococcus pyogenes), Peptococcus spp., Corynebacterium diphtheriae, Clostridium spp., Listeria monocytogenes, Bacillus anthracis, Propionibacterium acnes;
- gram-negative bacteria: Campylobacter jejuni, Neisseria gonorrhoeae, Neisseria meningitides, Helicobacter pylori, Moraxella catarrhalis, Haemophilus influenzae, Haemophilus ducreyi, Legionella spp., Brucella spp., Bordetella spp.;
- others: Borrelia burgdorferi, Bacteroides fragilis (josamycin sensitivity may be variable), Treponema pallidum, Chlamydia spp. (including Chlamydia trachomatis), Ureaplasma spp., Mycoplasma spp. (including Mycoplasma genitalium, Mycoplasma hominis, Mycoplasma pneumoniae), Chlamydophila spp. (including Chlamydophila pneumoniae).
Enterobacteriaceae are usually resistant to josamycin, so its use has little effect on the microflora gastrointestinal tract(Gastrointestinal tract). Active substance also demonstrates activity in cases of diagnosed resistance to erythromycin and other 14- and 15-membered macrolides. Cases of resistance to josamycin are reported less frequently than to 14- and 15-membered macrolides.
Instructions
Vilprafen is taken orally between meals. The tablet should be swallowed whole and washed down with a small amount of water.
For adolescents aged 14 years and older and adults, the recommended daily dose is 1-2 g of Vilprafen, which should be divided into 2-3 doses. The initial recommended dose is 1 g.
For globular and vulgar acne, 0.5 g of josamycin is prescribed 2 times a day for the first 2-4 weeks, then for 2 months the frequency of use is reduced to 0.5 g of josamycin 1 time a day (as maintenance therapy).
The duration of treatment is usually determined by the doctor. According to the recommendations of the World Health Organization on the use of antibiotic drugs, the duration of therapy for streptococcal infections should be at least 10 days.
If one dose of Vilprafen is missed, you should take the dose immediately. In cases where the time has come next appointment drug, the dose should not be increased.
A break in therapy or premature discontinuation of the drug reduces the likelihood of treatment success.
Indications for use: Vilprafen
Vilprafen 500 mg tablets are prescribed for the treatment of infectious and inflammatory diseases caused by sensitive active substance(josamycin) microorganisms:
- Infections of the lower parts respiratory tract – acute bronchitis, whooping cough, bronchopneumonia, psittacosis, pneumonia, including the atypical form;
- Infections of the ENT organs and upper respiratory tract - sinusitis, tonsillitis, paratonsillitis, pharyngitis, otitis media, laryngitis;
- Oral infections – periodontal disease and gingivitis;
- Scarlet fever (with hypersensitivity to penicillin);
- Diphtheria (in addition to diphtheria antitoxin therapy);
- Genital infections and urinary tract– prostatitis, urethritis, gonorrhea; with hypersensitivity to penicillin – lymphogranuloma venereum, syphilis;
- Mycoplasma (including ureaplasma), chlamydial and mixed infections of the genitals and urinary tract;
- Infections of soft tissues and skin - lymphadenitis, lymphangitis, boils, pyoderma, acne, anthrax, erysipelas(with hypersensitivity to penicillin).
Contraindications for use of Vilprafen
Heavy functional disorders liver. Hypersensitivity to the components of the drug and other macrolide antibiotics.
Vilprafen Use during pregnancy and children
Nursing and pregnant women should take Vilprafen only in cases where the expected benefit to the mother's health exceeds possible risk for the fetus or child.
Vilprafen Side effects
While taking Vilprafen, it is possible to develop disorders from various systems body:
- Gastrointestinal tract: rarely - heartburn, nausea, loss of appetite, diarrhea and vomiting. In case of severe persistent diarrhea, one must keep in mind the possibility of developing pseudomembranous colitis (life-threatening) caused by the action of the antibiotic;
- Hearing aid: in rare cases - dose-dependent transient hearing impairment;
- 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;
- Hypersensitivity reactions: in some cases - allergic skin reactions (for example, urticaria).
Drug interactions
The simultaneous use of Vilprafen with cephalosporins and penicillins should be avoided.
At joint use with lincomycin, the effectiveness of both drugs may decrease.
Vilprafen slows down the elimination of theophylline to a lesser extent than other antibiotic drugs of the macrolide group.
When used simultaneously with cyclosporine, it is possible to increase its concentration in the blood plasma up to nephrotoxic.
There are reports of increased vasoconstrictor effects with the combined use of ergot alkaloids, antibiotics and macrolide drugs.
Vilprafen slows down the elimination of astemizole or terfenadine, which increases the risk of developing life-threatening arrhythmias.
When used simultaneously with digoxin, the level of the latter in the blood plasma may increase.
When using the drug simultaneously with hormonal agents contraception, it is additionally necessary to use non-hormonal contraceptives.
Dosage Vilprafen
Vilprafen is prescribed orally.
For adults and children over 14 years of age, Vilprafen is prescribed in a daily dose of 1-2 g (suspension or tablets), usually in 3 doses (the first dose should be at least 1 g) between meals, the tablets are washed down with a small amount of liquid, swallowed whole. Vilprafen dispersible tablets are pre-dissolved in water.
For infants and children under 14 years of age, it is preferable to prescribe Vilprafen in the form of a suspension. The recommended daily dose of Vilprafen for newborns and children under 14 years of age is 30-50 mg/kg body weight, divided into three doses. In newborns and children under 3 months of age, the dose of Vilprafen should be selected exactly based on the child’s body weight
Overdose
Today's information about specific symptoms There is practically no overdose of Vilprafen. In this case, it is worth assuming an increase in the severity adverse reactions drug, mainly from the gastrointestinal tract.
Precautionary measures
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 different antibiotic drugs group of macrolides.
It has been established that the use of Vilprafen does not affect the ability to drive vehicles and perform potentially dangerous species works associated with increased concentration and speed of reactions.
International generic name:
josamycin
Dosage form
tablets, coated film-coated
Composition for 1 tablet
Josamycin - 500 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 macrolide group. 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., including methicillin-sensitive strains of Staphylococcus aureus), Streptococcus spp., incl. Streptococcus pyogenes and Streptococcus 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., Bruce lla spp. , Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni), sensitivity of Bacteroides fragilis may be variable), Chlamydia spp., incl. C. trachomatis, Chlamydophila spp. incl. Chlamydophila pneumoniae (formerly 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 binds 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. Passes the placental barrier and is excreted 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:
Tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), scarlet fever (in case of hypersensitivity to penicillin).
Acute bronchitis, exacerbation chronic bronchitis, community-acquired pneumonia, including those caused by atypical pathogens, whooping cough, psittacosis.
Gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess.
Blepharitis, dacryocystitis
Folliculitis, furuncle, furunculosis, abscess, anthrax, erysipelas, acne, lymphangitis, lymphadenitis, phlegmon, panaritium, wound (including postoperative) and burn infections.
Urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and/or mycoplasma, gonorrhea, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum.
Gastric ulcer and duodenum, chronic gastritis and etc.
Contraindications
Hypersensitivity to josamycin and other components of the drug
- hypersensitivity to other macrolides;
- severe violations liver functions;
- 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. 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 >1/10,000 to<1/1000, очень редко от <1/10 000.
Often - stomach discomfort, nausea
Uncommon: abdominal discomfort, vomiting, diarrhea
Rarely - stomatitis, constipation, loss of appetite
Very rarely - pseudomembranous colitis
Rarely - urticaria, angioedema and anaphylactoid reaction,
Very rarely - bullous dermatitis, exudative erythema multiforme, incl. syndrome
Stephen-Johnson.
Very rarely - liver dysfunction, jaundice
In rare cases, dose-related, transient hearing impairment has been reported
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
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.
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,
When josamycin is co-administered with antihistamines containing terfenadine or astemizole, the risk of life-threatening arrhythmias may increase.
There are isolated reports of increased vasoconstriction after co-administration of ergot alkaloids and macrolide antibiotics, including a single observation while taking josamycin.
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.
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 or operate machinery.
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 /
Astellas Pharma Europe B.V., Elisabethof 19, 2353 EW Leiderdorp, The Netherlands.
Manufacturer
Montefarmaco S.p.A.,
Italy/Montefarmaco S.r.A.
or Temmler Werke GmbH,
Weihenstephanerstr. 28, 81637 Munchen
Packer (primary packaging)
Montefarmaco S.p.A., Italy
or Temmler Werke GmbH,
Germany/Temmler Werke GmbH, Germany
Packer (secondary/tertiary packaging)
Montefarmaco S.p.A., Italy
or Temmler Italia S.r.L., Italy
or Temmler Werke GmbH,
Germany/Temmler Werke GmbH, Germany
Issue quality control
Temmler Italia S.r.L., Italy
or Temmler Werke GmbH, Germany
Subject to packaging at ORTAT CJSC
Manufacturer
Montefarmaco S.p.A.,
Italy/Montefarmaco S.r.A.
Via Galilei, n.7, 20016 Pero (MI), Italy
or Temmler Werke GmbH,
Germany/Temmler Werke GmbH, Germany
Weihenstephanerstr. 28, 81b73 Munchen
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 street 16, “Mosalarko Plaza-1” business center,
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.
Pharmacological properties
Pharmacodynamics.
Antibacterial drug from the macrolide group. 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., including methicillin-sensitive strains of Staphylococcus aureus), Streptococcus spp., incl. Streptococcus pyogenes and Streptococcus 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 of Bacteroides fragilis may be variable), Chlamydia spp., incl. C. trachomatis, Chlamydophila spp., incl. Chlamydophila pneumoniae (formerly 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 that exceed plasma levels and remain at therapeutic levels for a 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.
Infections of the skin and soft tissues: folliculitis, furuncle, 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 mycoplasmas, gonorrhea, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum.
Gastrointestinal diseases associated with H. pylori. Peptic ulcer of the stomach and duodenum, chronic gastritis, 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
Use during pregnancy is permitted after a medical assessment of the benefits/risks. When prescribing to nursing women, the penetration of the drug into breast milk should be taken into account.
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 >1/10,000 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-dependent, transient hearing impairment has been reported. Other: very rare - 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 experimental studies indicate that josamycin has less effect on theophylline elimination 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 or operate machinery.
Release form
Film-coated tablets 500 mg.
10 tablets in an aluminum/PVC blister. 1 or 3 blisters along with instructions for use are 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
1 tablet contains the active ingredient - josamycin - 500 mg
Release form
Film-coated tablets for oral administration, 10 pieces per pack.
pharmachologic effect
Antibiotic of the macrolide group. 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. (including methicillin-sensitive strains of Staphylococcus aureus), Streptococcus spp. (including Streptococcus pyogenes, Streptococcus pneumoniae), Corynebacterium diphtheriae, Listeria monocytogenes, Propionibacterium acnes, Bacillus anthracis, Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; gram-negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Borde tella spp., Brucella spp., Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni; susceptibility to Bacteroides fragilis may be variable; intracellular microorganisms: Chlamydia spp., in (including Chlamydia trachomatis), Chlamydophila spp. (including Chlamydophila pneumoniae, which was previously called Chlamydia pneumoniae), Mycoplasma spp. (including 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.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (including tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis);
- 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, community-acquired pneumonia, including those caused by atypical pathogens);
- whooping cough;
- psittacosis;
- infections in dentistry (including gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess);
- infections in ophthalmology (including blepharitis, dacryocystitis);
- infections of the skin and soft tissues (including folliculitis, furuncle, furunculosis, abscess, anthrax, erysipelas, acne, lymphangitis, lymphadenitis, phlegmon, panaritium);
- wound (including postoperative) and burn infections;
- infections of the urinary tract and genital organs (including urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and/or mycoplasma);
- gonorrhea, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum;
- gastrointestinal diseases associated with Helicobacter pylori (including gastric and duodenal ulcers, chronic gastritis).
Directions for use and doses
Typically, the duration of treatment, determined by the doctor, ranges from 5 to 21 days, depending on the nature and severity of the infection. In accordance with WHO recommendations on the use of antibiotics, the duration of treatment for streptococcal tonsillitis should be at least 10 days.
In anti-Helicobacter therapy regimens, josamycin is prescribed at a dose of 1 g 2 times / day for 7-14 days in combination with other drugs in their standard dosages (famotidine 40 mg / day or ranitidine 150 mg 2 times / day + josamycin 1 g 2 times / day daily + metronidazole 500 mg 2 times/day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 times/day + amoxicillin 1 g 2 times/day + josamycin 1 g 2 times/day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 times/day + amoxicillin 1 g 2 times/day + josamycin 1 g 2 times/day + bismuth tripotassium dicitrate 240 mg 2 times/day; famotidine 40 mg/day + furazolidone 100 mg 2 times/day + josamycin 1 g 2 times/day + bismuth tripotassium dicitrate 240 mg 2 times/day).
In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: amoxicillin 1 g 2 times / day + josamycin 1 g 2 times / day + tripotassium bismuth dicitrate 240 mg 2 times / day.
For ordinary and globular 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.
Contraindications
- severe liver dysfunction;
- children weighing less than 10 kg;
- hypersensitivity to other macrolide antibiotics;
- hypersensitivity to josamycin and other components of the drug.
special instructions
In the case of persistent severe diarrhea, one should keep in mind the possibility of developing life-threatening pseudomembranous colitis while taking 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).
Storage conditions
The drug should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 25°C.
