Indications for use:
Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the product:
– infections of the upper respiratory tract and upper respiratory tract (including pharyngitis, tonsillitis, paratonsillitis, otitis media, sinusitis, laryngitis);
– diphtheria (in addition to treatment with diphtheria antitoxin);
– scarlet fever (with increased sensitivity to penicillin);
– infections of the lower respiratory tract (including acute bronchitis, bronchopneumonia, pneumonia, including atypical form, whooping cough, psittacosis);
– infections of the oral cavity (including gingivitis and periodontal disease);
– infections of the skin and soft tissues (including pyoderma, boils, anthrax, erysipelas / with increased sensitivity to penicillin /, acne, lymphangitis, lymphadenitis);
– infections of the urinary tract and genital organs (including urethritis, prostatitis, gonorrhea; with increased sensitivity to penicillin – syphilis, venereal lymphogranuloma);
– chlamydial, mycoplasmal (including ureaplasma) and mixed infections of the urinary tract and genital organs.
Pharmacological action:
Macrolide antibiotic. It has a bacteriostatic effect due to the inhibition of protein synthesis by bacteria. When creating high concentrations in the focus of inflammation, it has a bactericidal effect.
Highly active against intracellular microorganisms: Chlamydia trachomatis and Chlamydia pneumonuae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila; against gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphtheriae; gram-negative aerobic bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis; against some anaerobic bacteria: Peptococcus, Peptostreptococcus, Clostridium perfringens.
The drug is also active against Treponema pallidum.
Pharmacokinetics.
Suction:
After oral administration, josamycin is rapidly absorbed from the gastrointestinal tract. Cmax is reached after 1-2 hours after administration. After 45 minutes after taking a dose of 1 g, the average plasma concentration of josamycin is 2.41 mg / l.
Distribution:
Plasma protein binding does not exceed 15%.
Taking the product with an interval of 12 hours ensures that the effective concentration of josamycin in the tissues is maintained throughout the day. The equilibrium state is reached after 2-4 days of regular intake.
Josamycin penetrates well through biological membranes and accumulates in various tissues: in the lung, lymphatic tissue of the palatine tonsils, organs of the urinary system, skin and soft tissues. Particularly high concentrations are found in the lungs, tonsils, saliva, sweat and lacrimal fluid. The concentration of josamycin in human polymorphonuclear leukocytes, monocytes and alveolar macrophages is approximately 20 times higher than in other cells of the body.
Metabolism:
Josamycin is biotransformed in the liver to less active metabolites.
Excretion
Excreted mainly in the bile, excretion in the urine is less than 20%.
Wilprafen (Vilprafen) method of administration and doses:
The recommended dose for adults and adolescents over 14 years of age is 1-2 g in 2-3 doses. The initial recommended dose is 1 g.
For the treatment of urogenital chlamydia – 500 mg 2 times / day for 12-14 days.
For the treatment of rosacea – 500 mg 2 times / day for 10-15 days.
For the treatment of pyoderma – 500 mg 2 times / day for 10 days.
For the treatment of chronic periodontitis, with abscessing of the periodontal bone – 500 mg 2 times / day for 12-14 days.
With ordinary and spherical (conglobat) acne, 500 mg 2 times / day are prescribed for the first 2-4 weeks, then 500 mg 1 time / day as maintenance therapy for 8 weeks.
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 must be at least 10 days.
For infants and children under the age of 14 years, it is preferable to prescribe the product in the form of a suspension. The daily dose is 30-50 mg / kg of body weight, divided into 3 doses. In newborns and toddlers under the age of 3 months, the dose should be selected in accordance with the exact body weight of the baby.
Shake the vial with the suspension before use.
Wilprafen (Vilprafen) contraindications:
– Hypersusceptibility to macrolide antibiotics.
– Severe hepatic impairment
Pregnancy and lactation:
Use during pregnancy and lactation is allowed after evaluation of the risk-benefit ratio of treatment.
drug interaction.
Vilprafen with other antibiotics:
Since bacteriostatic antibiotics may reduce the bactericidal effect of other antibiotics such as penicillins and cephalosporins, co-administration of josamycin with these types of antibiotics should be avoided. Josamycin should not be co-administered with lincomycin, as there may be a mutual decrease in their effectiveness.
Vilprafen with xanthines:
Some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical and experimental studies indicate that josamycin has less effect on theophylline release than other macrolide antibiotics.
Vilprafen with antihistamine products:
After the joint appointment of josamycin and antihistamine products containing terfenadine or astemizole, there may be a slowdown in the excretion of terfenadine and astemizole, which in turn can lead to the development of life-threatening cardiac arrhythmias.
Vilprafen with ergot alkaloids:
There have been individual reports of increased vasoconstriction following the co-administration of ergot alkaloids and macrolide antibiotics. There has been one case of ergotamine intolerance in a patient while taking josamycin. Therefore, the concomitant use of josamycin and ergotamine should be accompanied by appropriate patient monitoring.
Vilprafen with cyclosporine:
The co-administration of josamycin and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and the creation of a nephrotoxic concentration of cyclosporine in the blood. Plasma concentrations of cyclosporine should be regularly monitored.
Vilprafen with digoxin:
With the joint appointment of josamycin and digoxin, an increase in the level of the latter in the blood plasma is possible.
Vilprafen with hormonal contraceptives:
In rare cases, the contraceptive effect of hormonal contraceptives may be insufficient during treatment with macrolides. In this case, it is recommended to additionally use non-hormonal contraceptives.
Overdose.
To date, there are no data on specific symptoms of poisoning. In case of overdose, the occurrence of the symptoms described in the “Side effects” section should be assumed, especially from the gastrointestinal tract.
Wilprafen (Vilprafen) side effects:
From the digestive system: infrequently – lack of appetite, nausea, heartburn, vomiting, dysbacteriosis, diarrhea; in some cases – an increase in the activity of hepatic transaminases, a violation of the outflow of bile and jaundice.
Allergic reactions: in isolated cases – urticaria.
On the part of the organ of hearing: infrequently – dose-dependent transient hearing loss.
Other: in some cases – candidiasis.
Release form:
Coated tablets: 10 pcs. – cellular contour packings (1) – packs of cardboard.
Suspension for oral administration: 100 ml – dark glass bottles (1) complete with a measuring cup – packs of cardboard.
Synonyms:
Josamycin (Josamycin)
Storage conditions:
List B. The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 25°C. The shelf life is 4 years.
The drug is dispensed by prescription.
Wilprafen (Vilprafen) composition:
1 coated tablet contains 500 mg of josamycin.
10 ml oral suspension contains 300 mg of josamycin.
Other ingredients: methylcellulose, microcrystalline cellulose, colloidal anhydrous silica, polysorbate 80, sodium carboxymethylcellulose, talc, magnesium stearate, macrogol 6000, titanium dioxide (E171), aluminum hydroxide, poly(ethacrylate methyl methacrylate) -30% dispersion.
Additionally:
In patients with renal insufficiency, treatment should be carried out taking into account the results of appropriate laboratory tests.
Consideration should be given to the possibility of cross-resistance to various macrolide antibiotics (eg, organisms resistant to treatment with chemically related antibiotics may also be resistant to josamycin).
Producer:
YAMANOUCHI PHARMA
Representation: HEINRICH MAC NASL. GmbH & Co. KG
Germany
Attention!
Before using the medication“Wilprafen (Wilprafen)” must be consulted with a doctor.
The instructions are provided solely for familiarization with “Wilprafen (Wilprafen) “.