Wilprafen pills 500mg №10

Wilprafen (Wilprafen)

Active ingredient and dosage form

Coated tablets: 1 pill contains josamycin 500 mg,
Excipients: methylcellulose; MCC; silica colloidal anhydrous; polysorbate 80; sodium carboxymethylcellulose; talc; Magnesium stearate; macrogol 6000; titanium dioxide (E171); aluminum hydroxide; poly- (ethacrylate methyl methacrylate) -30% dispersion
10 pieces. in a blister; in the box 1 blister.
Oral suspension: 10 ml (1 measuring cup) contains josamycin 300 mg (corresponding to josamycin propionate - 320.4 mg),
Excipients: methyl hydroxypropyl cellulose; MCC; silica colloidal anhydrous; sorbmta trioleate; sodium carboxymethylcellulose; sodium citrate; cetylpyridinium chloride; dimethicone; aromatic substances; sucrose (6.5 g / 10 ml suspension is equivalent to 0.54 dietary units); purified water;
100 ml in a bottle of dark glass; in the box one bottle complete with a graduated graduated glass of 10 ml.

Pills: white or almost white, oblong, biconvex, with a risk in the middle on both sides.
Suspension: viscous, white, with a fruity odor, no sediment.

The macrolide antibiotic produced by Streptomyces narbonensis var. Josamyceticus.

Mechanism of action

Antibacterial (bacteriostatic, bactericidal).
Inhibits protein synthesis by bacteria. When creating high concentrations in the inflammatory focus, it has a bactericidal effect. It is highly active against intracellular microorganisms (Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila); gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae (pneumococcus), Corynebacterium diphteriae)Gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis), and also against some anaerobic bacteria (Peptococcus, Peptostreptococcus, Clostridium perfringens). Slightly influences enterobacteria, therefore it does not change the natural bacterial flora of the gastrointestinal tract. Effective with Erythromycin resistance. Resistance to josamycin develops less frequently than to other macrolide antibiotics.

After ingestion, josamycin is rapidly and completely absorbed from the gastrointestinal tract, food intake does not affect bioavailability. C_max in serum is achieved in 1-2 hours after administration. About 15% of josamycin binds to plasma proteins. Especially high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and tears. Concentration in sputum exceeds plasma concentration by 8–9 times. Accumulates in the bone tissue. It passes the placental barrier, is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and is excreted mainly in the bile. Excretion of the drug in the urine - less than 20%.

Indications and usage

Infections (including chlamydia, mycoplasma and mixed) of the respiratory tract and ENT organs (sore throat, pharyngitis, otitis media, sinusitis, laryngitis, tonsillitis and paratonsillitis, acute bronchitis, pneumonia, (includingatypical form); skin and soft tissues (pyoderma, furunculosis, anthrax, erysipelas (with increased sensitivity to penicillin), acne, lymphangitis, lymphadenitis, venereal lymphogranuloma) urinary system (pyelonephritis, prostatitis, chlamydia, mycoplasmosis, ureaplasmosis, gonorrhea, syphilis); dental infections (gingivitis, periodontal disease); in ophthalmology (blepharitis, dacryocystitis); diphtheria (in addition to treatment with diphtheria toxoid), scarlet fever (in the case of hypersensitivity to penicillin), whooping cough, psittacosis.

Contraindications

Hypersensitivity, severe abnormal liver function, prematurity.

Dosage and Administration

The drug should be taken orally, pills - without chewing, drinking down with a small amount of water, the suspension is prescribed between meals (the contents of the vial are pre-shaken): 1-2 g per day in 2-3 doses.
The duration of treatment of streptococcal infections is at least 10 days.
For the treatment of common and nodular acne - 500 mg 2 times a day for 2-4 weeks, then - 500 mg 1 time per day for 8 weeks.
Newborns and children up to 14 years - 30-50 mg / kg per day in 3 doses.

Pregnancy and Breastfeeding

Perhaps according to indications. It is the drug of choice for treating chlamydial infection in pregnant women.

Adverse reactions

On the part of the digestive tract: rarely - loss of appetite, nausea, heartburn, vomiting, dysbiosis, diarrhea.In the case of persistent severe diarrhea, one should bear in mind the possibility of developing, against the background of antibiotics, life-threatening pseudomembranous colitis.
Allergic reactions: in extremely rare cases - urticaria.
From the hearing aid: in rare cases, dose-dependent transient hearing loss.
Other: very rarely - candidiasis.

Drug interactions

If necessary, simultaneous use with other antibiotics should be borne in mind that bacteriostatic antibiotics can reduce the bactericidal effect of other antibiotics, such as penicillins and cephalosporins, so you should avoid co-administration of josamycin with these types of antibiotics. Josamycin should not be administered together with Lincomycin, because Perhaps a mutual decrease in efficiency.
With simultaneous use of macrolide antibiotics with xanthines, it has been revealed that some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to intoxication. Clinical and experimental studies indicate that josamycin has less effect on the release of theophylline than other macrolide antibiotics.
After co-administration of josamycin and antihistamine preparations containing terfenadine or astemizole, a delay in excretion of terfenadine and astemizole may be observed, which in turn may lead to the development of life-threatening cardiac arrhythmias.
After co-administration of ergot alkaloids and macrolide antibiotics, there are separate reports of increased vasoconstriction. Therefore, the concomitant use of josamycin and ergotamine should be accompanied by appropriate monitoring of patients.
The joint appointment of josamycin and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and the creation of nephrotoxic concentration of cyclosporine in the blood. Plasma cyclosporine concentration should be regularly monitored.
With the joint appointment of josamycin and Digoxin may increase the level of the latter in the blood plasma.
In rare cases, the contraceptive effect of hormonal contraceptives may not be sufficient during treatment with macrolide antibiotics. In this case, it is recommended to additionally use non-hormonal contraceptives.

Overdosage

Symptoms: increased side effects, especially on the part of the gastrointestinal tract (there are no data on specific symptoms of poisoning).

Precautions should be prescribed against the background of renal failure.

Special notes

If one dose is missed, you should immediately take a dose of the drug, but if it is time to take the next dose, you should return to the normal treatment regimen. Do not take a double dose. A break in treatment or premature discontinuation of the drug reduces the likelihood of treatment success.
Consideration should be given to the possibility of cross-resistance to various antibiotics of macrolides (for example, microorganisms that are resistant to treatment with antibiotics related by chemical structure may also be resistant to josamycin)

Storage conditions

List B. In the dark place at a temperature of no higher than 25 ° C

4 years.