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

Excipients: povidone 10.0 mg, starch 38.3 mg, silicon dioxide colloidal anhydrous 2.0 mg, talc purified 1.0 mg, magnesium stearate 4.0 mg, sodium croscarmellose 6.0 mg;

composition of film shell: hypromellose 10.0 mg, titanium dioxide 1.0 mg, talc purified 1.0 mg, diethyl phthalate 1.0 mg, dye quinoline yellow 0.7 mg.

Description:

Round biconvex tablets, film-coated, yellow.

Pharmacotherapeutic group:anti-tuberculosis drug

ATX: & nbsp

J.04.A.D.01 Prothionamide

Pharmacodynamics:

Second-line anti-tuberculosis drug. It acts bacteriostatically.blocks the synthesis of mycolic acids, which are the most important structural component of the mycobacterium tuberculosis cell wall. Has the properties of a nicotinic acid antagonist. In high concentrations, it breaks the synthesis of the protein of the microbial cell and acts bactericidal. Effective against mycobacteria tuberculosis, resistant to drugs of the I series. Strengthens phagocytosis in the focus of specific inflammation. The use in combination with other anti-tuberculosis drugs reduces the likelihood of developing tuberculosis resistance.

Pharmacokinetics:

Prothionamide is rapidly absorbed in the gastrointestinal tract, reaching a maximum drug concentration in the blood plasma 2-3 hours after ingestion. Penetrates into healthy and pathologically altered tissues (tuberculosis foci, including encapsulated, caverns in the lungs, serous and purulent pleural effusion, cerebrospinal fluid during meningitis, penetrates the placental barrier). Metabolised in the liver, partially turning into a sulfoxide, also possessing tuberculostatic activity. It is excreted mainly by the kidneys (up to 15-20% of the dose taken) excreted unchanged.

Indications:

Prothionamide is used to treat all forms of tuberculosis (both pulmonary and extrapulmonary): infiltrative, ulcerative and exudative forms. Including, with the resistance of the pathogen to other anti-tuberculosis drugs (I series) or their intolerance.

Contraindications:

Prothionamide can not be used with individual hypersensitivity to the components of the drug; during pregnancy and lactation, acute gastritis, stomach ulcer and duodenal ulcer, erosive ulcerative colitis, acute hepatitis, liver cirrhosis, chronic alcoholism.

Children up to 3 years (for this dosage form).

Carefully:Diabetes mellitus, severe hepatic insufficiency.

Dosing and Administration:

Inside, after eating. The daily dose for adults is 0.5-1 g / day in 3 divided doses. Begin treatment with 250 mg / day, then increase the dose by 250 mg every other day.

In patients older than 60 years and with a body weight of less than 50 kg, the daily dose should not exceed 750 mg (250 mg 3 times per day).

Children - at a rate of 10-20 mg / kg per day.

Duration of treatment - 8-9 months.

Side effects:

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

From the nervous system: insomnia, agitation, depression, anxiety, rarely - dizziness, drowsiness, headache, asthenia, polyneuropathy, 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:

Compatible with isoniazid, pyrazinamide, cycloserine and other antituberculous drugs.

Isoniazid increases the concentration of protionamide in plasma.

With the combined use of a protionamide with isoniazid and cycloserine, special attention should be paid to the possibility of mental disorders.

Special instructions:

It is necessary to avoid the joint use of protionamide and alcohol because of the danger of inhibition of the central nervous system (associated with increased toxic effect of alcohol).

Because the drug is constantly used in combination with other antituberculous drugs, regular monitoring of serum transaminases, gamma-glutamyltranspeptidase and alkaline phosphatase.

In patients with diabetes, blood glucose levels need to be monitored at least once a month.

Skin reactions may be the first signs of pellagruide-like side effects.

If they occur, the drug should be discarded.

Form release / dosage:

Tablets, film-coated, 250 mg.

Packaging:

For 10 tablets in a blister of PVC / Aluminum foil.

For 5 or 10 blisters in a cardboard box together with instructions for use.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

In a place inaccessible to children.

Shelf life:

4 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N010795

Date of registration:21.06.2010

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp09.09.2015

Illustrated instructions

Instructions

Prothionamide (Protionamide )