Wilprafen solutab, pills 1000mg, 10pcs

Composition

Active ingredient:

josamycin 1000 mg, (equivalent to josamycin propionate) – 1067.66 mg.

Auxiliary substances:  

Microcrystalline cellulose-564.53 mg;

giprolose-199.82 mg;

sodium docusate-10.02 mg;

aspartame-10.09 mg;

colloidal silicon dioxide-2.91 mg;

strawberry flavor-50.05 mg;

magnesium stearate-34.92 mg

Pharmacological action

of Wilprafen solutab – bactericidal, bacteriostatic, antibacterial.

Pharmacodynamics

The drug is used to treat bacterial infections; the bacteriostatic activity of josamycin, like other macrolides, is due to inhibition of bacterial protein synthesis. When creating high concentrations in the focus of inflammation, it has a bactericidal effect.

Josamycin is highly active against intracellular bacteria (Chlamydia trachomatis andChlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila); gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphtheriae), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis), and also against some anaerobic bacteria (Peptococcus, Peptostreptococcus, Clostridium perfringens). It has little effect on enterobacteria, so it does not change the natural bacterial flora of the gastrointestinal tract much. It is effective for erythromycin resistance. Resistance to josamycin develops less frequently than to other macrolide antibiotics.

Pharmacokinetics

After oral use, josamycin is rapidly and completely absorbed from the gastrointestinal tract, food intake does not affect bioavailability. Cmax of josamycin in serum is reached 1-2 hours after use. About 15% of josamycin binds to plasma proteins. Particularly high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in the bone tissue. Passes the placental barrier, is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and is mainly excreted in the bile. Urinary excretion of the drug is less than 20%.

Indications

Acute and chronic infections caused by microorganisms sensitive to the drug, for example:

• infections of the upper respiratory tract and ENT-organs, sore throat, pharyngitis, paratonsillar, laryngitis, otitis media, sinusitis, diphtheria (in addition to the treatment of diphtheria toxoid), and scarlet fever in case of hypersensitivity to penicillin;
• infections of the lower respiratory tract, acute bronchitis, exacerbation of chronic bronchitis, pneumonia (including caused by atypical pathogens), whooping cough, fever;
• dental infections gingivitis and periodontal disease;
• infections in ophthalmology — blepharitis, dacryocystitis;
• infections of skin and soft tissues — pyoderma, furunculosis, anthrax, erysipelas (in case of hypersensitivity to penicillin), acne, lymphangitis, lymphadenitis, lymphogranuloma venereum;
• infections of the genitourinary system, prostatitis, urethritis, gonorrhoea, syphilis (in case of hypersensitivity to penicillin), chlamydia, Mycoplasma (including Ureaplasma) and mixed infections.

Use during pregnancy and lactation

Possibly based on indications.

It is the drug of choice for the treatment of chlamydia infection in pregnant women.

Contraindications

• severe hepatic impairment;
• children weighing less than 10 kg;
• hypersensitivity to the components of the drug;
• hypersensitivity to macrolide antibiotics.

Side effects

From the digestive tract:  rarely — loss of appetite, nausea, heartburn, vomiting, dysbiosis, diarrhea. In the case of persistent severe diarrhea, one should keep in mind the possibility of developing life-threatening pseudomembranous colitis against the background of antibiotics.

Allergic reactions:  in extremely rare cases — urticaria.

From the side of the hearing aid:  in rare cases — dose-dependent transient hearing loss.

Other services:  very rarely — candidiasis.

Interaction

Other antibiotics.  Since bacteriostatic antibiotics may reduce the bactericidal effect of other antibiotics, such as penicillins and cephalosporins, co-use of josamycin with these types of antibiotics should be avoided. Josamycin should not be co-administered with lincomycin, as their effectiveness may be mutually reduced.

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.

Antihistamines.  After co-use of josamycin and antihistamines containing terfenadine or astemizole, there may be a slowdown in the elimination of terfenadine and astemizole, which in turn can lead to the development of life-threatening cardiac arrhythmias.

Ergot alkaloids. There are individual reports of increased vasoconstriction after co-use of ergot alkaloids and macrolide antibiotics. There was one case of a patient’s lack of tolerance to ergotamine when taking josamycin. Therefore, concomitant use of josamycin and ergotamine should be accompanied by appropriate monitoring of patients.

Cyclosporine.  Concomitant use of josamycin and cyclosporine may cause an increase in the level of cyclosporine in blood plasma and the creation of a nephrotoxic concentration of cyclosporine in the blood. The plasma concentration of cyclosporine should be monitored regularly.

Digoxin.  With the combined use of josamycin and digoxin, an increase in the level of the latter in blood plasma is possible.

Hormonal contraceptives.  In rare cases, the contraceptive effect of hormonal contraceptives may not be sufficient during macrolide treatment. In this case, it is recommended to additionally use non-hormonal contraceptives.

How to take, course of use and dosage

Inside, tablets – without chewing, washed down with a small amount of water, the suspension is prescribed between meals (the contents of the bottle are pre-shaken): 1-2 g per day in 2-3 doses.

The duration of treatment for streptococcal infections is at least 10 days.

For the treatment of ordinary and spherical acne-500 mg 2 times a day for 2-4 weeks, then-500 mg 1 time a day for 8 weeks.

Newborns and children under 14 years of age – 30-50 mg / kg per day in 3 divided doses.

Overdose

To date, there are no data on specific symptoms of poisoning.

In case of overdose, the symptoms described in the section “Side effects” should be expected to occur, especially from the gastrointestinal tract.

Special instructions

If you miss one dose, you should immediately take a dose of the drug, but if it is time to take the next dose, you should return to the usual treatment regimen. Do not take a double dose. A break in treatment or premature discontinuation of the drug reduces the likelihood of success of treatment.

Consideration should be given to the possibility of cross-resistance to various macrolide antibiotics (for example, microorganisms resistant to treatment with chemically related antibiotics may also be resistant to josamycin).

Form of production

Tablets

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Josamycin

Conditions of release from pharmacies

By prescription

Dosage form

soluble tablets

Description

For adults as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Otitis media, Blepharitis, Pneumonia, Purulent wounds, Whooping cough, Pharyngitis, Gastric and Duodenal Ulcers, Gastritis, Respiratory tract infections, Laryngitis, Chlamydia, Chronic infections