Prothionamidum
Producer: JSC Pharmasintez Russia
Code of automatic telephone exchange: J04AD01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 250,0 mg of Prothionamidum.
Excipients: starch corn, cellulose microcrystallic, lactose, Natrium benzoicum, calcium dihydrophosphate, magnesium stearate, talc, sodium carboxymethylstarch.
Tablet cover: gipromelloza, diethyl phthalate, dye orange-yellow.
The synthetic antituberculous remedy having active bacteriostatic and bactericidal action.
Pharmacological properties:
Pharmacodynamics. An antituberculous remedy, on chemical structure it is close to Etioniamidum. Has bacteriostatic action generally on the breeding tuberculosis mycobacteria (including atypical), on out of - and intracellularly located microorganisms. Blocks synthesis of the mikoliyevy acids which are the most important structural component of a cell wall of mycobacteria of tuberculosis, has properties of the antagonist of niacin. In high concentration breaks synthesis of protein of a microbic cell. Secondary stability develops quickly.
Pharmacokinetics. In digestive tract it is soaked up quickly. Cmax in plasma is noted in 2-3 hours after intake. Easily gets into bodies and fabrics (tuberculous focuses, cavities in lungs, a serous and purulent pleural exudate, SMZh at meningitis). It is metabolized in a liver (one of metabolites - sulphoxide, has tuberculostatic activity). It is removed by kidneys and with bile (15-20% in not changed look).
Indications to use:
Tuberculosis (pulmonary and extra pulmonary forms), resistant to treatment by antitubercular drugs of the main row or at their intolerance.
Route of administration and doses:
Inside, after food. The daily dose for adults at the rate of 12.5 mg/kg makes 0.5-1.0 g/days in 2-3 receptions. At patients 60 years are more senior and at body weight less than 50 kg the daily dose should not exceed 750 mg (on 250 mg 2 times a day). To children - at the rate of 10-20 mg/kg a day. Treatment duration - 8-9 months.
Features of use:
It is necessary to control monthly function of a liver, with care to appoint at a diabetes mellitus, a heavy liver failure. It is necessary to consider a possibility of cross stability and not to appoint Prothionamidum at the established resistance to Etioniamidum.
Side effects:
At use of drug gastrointestinal frustration, dizziness, tachycardia, weakness, paresthesias, allergic skin reactions are possible, but by-effects are less expressed, than at use of Etioniamidum.
Interaction with other medicines:
Let's combine with an isoniazid, Pyrazinamidum, Cycloserinum, etc. antitubercular drugs.
Contraindications:
Hypersensitivity, acute gastritis, peptic ulcer of a stomach and 12-perstny gut, erosive and ulcer colitis, acute hepatitis, cirrhosis, pregnancy, lactation period, children's age.
Overdose:
The dispepsichesky phenomena which were stopped by fractional purpose of this drug and its reception after food, and also purpose of antiemetic drugs were most often observed.
Storage conditions:
List B. At a temperature not over 30 ºС in the places not available to children.
Issue conditions:
According to the recipe
Packaging:
On 50 tablets in a plastic jar