Prothionamide - instructions for use, dose, side effects, contraindications

Excipients: core: cellulose microcrystalline 10.5 mg, corn starch 49.0 mg, magnesium stearate 3.5 mg, lactose monohydrate 30.0 mg, silicon dioxide colloid (aerosil) 7.0 mg;

film sheath: a ready-made mixture for a film sheath; shell composition: hydroxypropylmethylcellulose (hypromellose) 6.6 mg, titanium dioxide 2.407 mg, glyceryl caprylcaprate 0.9 mg, dye iron oxide yellow 0.023 mg, quinoline yellow aluminum lacquer 0.07 mg.

Description:

The tablets covered with a film cover, yellow, color, biconcave form. The cross-section of the tablet is yellow.

Pharmacotherapeutic group:anti-tuberculosis drug

ATX: & nbsp

J.04.A.D.01 Prothionamide

Pharmacodynamics:

Synthetic anti-tuberculosis drug II series. It operates on mycobacteria, resistant to drugs of the I series, bacteriostatic. It blocks the synthesis of mycolic acids, has the properties of a nicotinic acid antagonist. In high concentrations, the synthesis of the protein of the microbial cell is disrupted. It has a bacteriostatic effect mainly on the reproducing mycobacterium tuberculosis (including atypical ones), on extra- and intracellularly located microorganisms.

Pharmacokinetics:

Quickly absorbed from the gastrointestinal tract, the maximum concentration in the blood is reached after 2-3 hours after ingestion. Easily penetrates into tissues (tubercular foci, caverns in the lungs, pleural effusion, cerebrospinal fluid during meningitis). Partially metabolized in sulfoxide (has tuberculostatic effect). It is excreted by the kidneys and bile (15-20% unchanged).

Indications:

Tuberculosis (pulmonary and extrapulmonary forms resistant to treatment with anti-tuberculosis drugs of the 1st series or with their poor tolerance): infiltrative, ulcerative and exudative processes.

Contraindications:

Children's age (under 18 years), hypersensitivity, acute gastritis, peptic ulcer and duodenal ulcer, erosive and ulcerative colitis, acute hepatitis, cirrhosis, chronic alcoholism, pregnancy, breast-feeding.

Carefully:

Diabetes mellitus, severe hepatic insufficiency.

Pregnancy and lactation:The drug is contraindicated in pregnancy and lactation.

Dosing and Administration:

Inside, after eating.

Adults: 250 mg 3 times a day, with good tolerability - 500 mg 2 times a day.

Patients over 60 years of age and with a body weight of less than 50 kg: in a daily dose of not more than 750 mg.

Side effects:

From the digestive system: nausea, vomiting, diarrhea, hypersalivation, "metallic" taste in the mouth, impaired liver function.

From the nervous system: insomnia, agitation, depression, anxiety, rarely - dizziness, drowsiness, headache, asthenia, in single cases - paresthesia, peripheral neuropathy, optic neuritis.

From the cardiovascular system: tachycardia, weakness, orthostatic hypotension.

From the endocrine system: hypoglycemia in patients with diabetes mellitus, gynecomastia, dysmenorrhea, hypothyroidism, decreased potency.

Allergic reactions: skin rash.

Interaction:

Slows the metabolism of other drugs (including isoniazid and barbiturates). When combined with isoniazid and cycloserine, the possibility of developing mental disorders should be considered.

Special instructions:

It should not be prescribed for the resistance of mycobacterium tuberculosis to ethionamide (cross resistance).

During the period of treatment, the level of serum transaminases, gamma-glutamintransferase and alkaline phosphatase must be constantly monitored, and in patients with diabetes mellitus - monitoring of blood glucose level (at least once a month).

Form release / dosage:

Tablets, film-coated, 250 mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

5 or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

For 50, 100 or 500 tablets (for hospitals) are placed in a jar a polymer or a can of polypropylene with a lid of polypropylene or high-density polyethylene or a can of polyethylene terephthalatefor medicinal products, with a screw cap or with the control of the first autopsy.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006794/09

Date of registration:26.08.2009

The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Information update date: & nbsp09.09.2015

Illustrated instructions

Instructions

Prothionamide (Protionamide)