VYLPRAFEN Soljutab

Active material: Dzhozamitsin
When ATH: J01FA07
CCF: Macrolide antibiotics
ICD-10 codes (testimony): A22, A31.0, A36, A37, A38, A46, A48.1, A50, A51, A52, A54, A55, A56.0, A56.1, A56.4, A70, B96.0, H01.0, H04.3, H04.4, H66, I89.1, J00, J01, J02, J03, J04, J15, J15.7, J16.0, J20, J31, J32, J35.0, J37, J42, K05, K12, L01, L02, L03, L08.0, L70, N30, N34, N41, N70, N71, N72
When CSF: 06.07.01
Manufacturer: YAMANOUCHI EUROPE B.V.. (Netherlands)

Pharmaceutical form, composition and packaging

Dispersible tablets white or white with a yellowish tint, oblong, with an inscription “JESUS” and Valium on one side and the inscription “1000” – another, with a sweet taste and smell of strawberries.

Excipients: microcrystalline cellulose, hydroksypropyltsellyuloza, sodium docusate, Aspartame, silicon dioxide, anhydrous, strawberry flavor, magnesium stearate.

5 PC. – blisters (2) – packs cardboard.

Pharmacological action

Macrolide antibiotics. It has a bacteriostatic effect, mediated inhibition of protein synthesis by bacteria. When you create inflammation in high concentrations has a bactericidal effect.

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

Little effect on the enterobacteria, so little change natural bacterial flora of the gastrointestinal tract.

Effective for resistance to erythromycin. Josamycin resistance develops less, than to other antibiotics of the macrolide.

Pharmacokinetics

Absorption

After oral josamycin rapidly and completely absorbed from the gastrointestinal tract. Eating does not affect the bioavailability of. FROM_max achieved through 1-2 h after administration.

Distribution

Plasma protein binding is less than 15%.

Especially high concentrations in the lungs are determined, tonsils, saliva, sweat and tear fluid. Josamycin sputum concentration higher than the concentration in plasma 8-9 time. It accumulates in the bone. It penetrates through the placental barrier, excreted in breast milk.

Metabolism

Josamycin biotransformed in the liver to less active metabolites.

Deduction

Write mainly in the bile, urinary excretion of less than 20%.

Testimony

Acute and chronic infectious-inflammatory diseases, caused by susceptible to malaria infections:

- Infections of the upper respiratory tract and ENT (incl. pharyngitis, tonsillitis, paratonzillit, otitis media, sinusitis, laringit);

- Diphtheria (further treatment with diphtheria antitoxin);

- Scarlet fever (in case of hypersensitivity to penicillin);

- Infections of the lower respiratory tract (incl. acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);

- Pertussis;

- Psittacosis;

- Oral infections (incl. gingivitis and periodontal disease);

- Infections of the eye (incl. .Aloe, dakriocistit);

- Infections of the skin and soft tissues (incl. pyoderma, furunculosis, acne, limfangit, lymphadenitis);

- anthrax;

- Mug (in case of hypersensitivity to penicillin);

- Infections of the urinary tract and genital organs (incl. uretrit, prostatitis, gonorrhea, Syphilis / at hypersensitivity to penicillin /, khlamidiinyye, mycoplasma / incl. ureaplazmennogo / and mixed infections).

Dosage regimen

The recommended daily dose Adults and adolescents older 14 years is 1-2 g. If necessary, the dose may be increased to 3 g / day. The daily dose should be divided into 2-3 admission.

The daily dose for children establish the rate of 40-50 mg / kg body weight 2-3 admission.

At ordinary and šarovidnyh ugrâh The recommended dose is 500 mg 2 times / day during the first 2-4 weeks, further – 500 mg 1 time / day as maintenance therapy for 8 weeks.

Dispersible tablets can be taken 2 ways: swallowed whole, drinking water, or pre-pre-diluted with water (least 20 ml). Before taking should be thoroughly mixed the resulting suspension.

Typically, the duration of treatment determined by the doctor. In accordance with WHO recommendations on the use of antibiotic treatment of streptococcal infections the duration should be at least 10 days.

When receiving the pass vilprafen^® Soljutab should immediately take the dose. However, if it is time to receive the next dose, should not take the missed dose, We need to get back to normal treatment. Do not take double the dose. A break in the treatment or premature discontinuation of treatment reduces the probability of success.

Side effect

From the digestive system: rarely – anorexia, nausea, heartburn, vomiting, dysbiosis, diarrhea; in some cases – transient increase in liver transaminases, rarely accompanied by violation of the outflow of bile and jaundice. In the case of the intake of the drug-resistant severe diarrhea should be borne in mind the possibility of pseudomembranous colitis.

Allergic reactions: in a few cases – skin reactions (hives).

On the part of the organ of hearing: rarely – dozozavisimыe prehodyashtie hearing impaired.

Other: in some cases – candidiasis.

Contraindications

- Expressed human liver;

- Hypersensitivity to macrolide antibiotics.

Pregnancy and lactation

Permitted use vilprafen^® Soljutab during pregnancy and lactation (breast-feeding) on indications.

The European branch of the WHO recommends josamycin as the drug of choice for treatment of chlamydial infection in pregnant women.

Cautions

Patients with renal failure the drug should be administered under the supervision of renal function.

In appointing vilprafen^® Soljutab should consider the possibility of cross-resistance to a variety of macrolide antibiotics (eg, organisms, resistant to treatment related in chemical structure Antibiotic, They may also be resistant to josamycin).

Overdose

To date, no data on the specific symptoms of overdose vilprafen^® Soljutab. In case of overdose should be suspected appearance and increasing incidence of side effects from the digestive system.

Drug Interactions

Bacteriostatic antibiotics may reduce the bactericidal action of other antibiotics, such as penicillins and cephalosporins (such combinations should be avoided).

In an application with josamycin lincomycin may decrease the effectiveness of both drugs.

Some antibiotics macrolide slow elimination xanthine (teofillina), that can lead to toxic effects of the latter. In clinical and experimental studies have shown, josamycin that has a less pronounced effect on the elimination of theophylline, than other antibiotics macrolide.

In an application josamycin and antihistamines, containing terfenadine or astemizole, may slow excretion last, which increases the risk of life-threatening arrhythmias.

There are some reports on the strengthening of vasoconstriction, while the use of antibiotics and macrolide ergot alkaloids. Considering this, while the application of josamycin and ergotamine should monitor the patient's condition.

In an application josamycin and cyclosporine may increase cyclosporine levels in the blood plasma and the creation of its nephrotoxic concentration. Therefore, the combination of these drugs should regularly monitor the concentration of cyclosporine in the blood plasma.

In an application josamycin and digoxin may increase the level of the latter in the blood plasma.

In rare cases during treatment with macrolide contraceptive effect of hormonal contraceptives can be effective enough (It may require the use of non-hormonal methods of contraception).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 2 year.