Active substanceProthionamideProthionamide
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  • Dosage form: & nbspcoated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: protionamide 250 mg;

    Excipients: Corn starch 34 mg Colloidal silicon dioxide 2 mg, croscarmellose sodium 6 mg magnesium stearate 4 mg Povidone 10 mg Talc 4 mg;

    shell: dye quinoline yellow.

    Description:

    Round, biconvex tablets, covered with a film membrane of yellow color, smooth on both sides. The color of the tablet is yellow at the break.

    Pharmacotherapeutic group:anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.D.01   Prothionamide

    Pharmacodynamics:

    Anti-tuberculosis drug II series.

    Bacteriostatic, blocks synthesis mikolevykh acids which are the major structural component of the cell wall of Mycobacterium tuberculosis.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 I series.

    The use in combination with other anti-tuberculosis drugs reduces the likelihood of tuberculosis resistance.

    Pharmacokinetics:

    Prothionamide is rapidly absorbed by the gastrointestinal tract, creating a maximum concentration of the drug in the blood plasma 2-4 hours after ingestion, penetrates into healthy and pathologically altered tissue types (tuberculous foci and caverns in the lungs, serous and purulent pleural effusion, cerebrospinal fluid with meningitis ). In the body it is partially converted into sulfaoxide, which has tuberculostatic activity. Partially excreted unchanged (up to 15-20% of the dose) with urine and feces.

    Indications:

    Prothionamide is used to treat all forms of tuberculosis, including, with the resistance of the pathogen to other anti-tuberculosis drugs (I series) or their intolerance.

    Contraindications:

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

    Carefully:Diabetes mellitus, severe hepatic insufficiency.
    Dosing and Administration:

    Take the drug inside after eating.

    Adults appoint 0.25 g 3 times a day, with good tolerance - 0.5 g 2 times a day.

    In patients older than 60 years and with a body weight of less than 50 kg, the daily dose should not exceed 0.75 g (more often prescribed 0.25 g twice daily).

    Children are appointed at the rate of 10-20 mg / kg of body weight per day.

    Side effects:

    Side effects of protionamide are manifested from the gastrointestinal tract, liver, skin, endocrine and nervous system.

    On the part of the gastrointestinal tract: loss of appetite, nausea, vomiting, dryness or hypersalivation, metallic taste in the mouth. After drug withdrawal, these phenomena, as a rule, quickly pass.

    Often during the treatment there is a rise in the blood level of transaminases. Rare violations of liver function with signs of hepatitis and jaundice are rare.Hepatotoxicity of the drug depends on existing violations of the liver, such as liver damage due to alcoholism or after surgery. These side effects are noted especially in combination therapy with isoniazid, rifampicin and pyrazinamide.

    Skin reactions are rare, in some cases described pellagro-like reactions, respectively, with a combination of skin manifestations and disorders from the central nervous system.

    Sometimes there are violations of the endocrine system. Along with the development of hypoglycemia (a decrease in blood sugar of less than 50 mg%) in diabetic patients, the development of gynecomastia (an increase in mammary glands in men) is described. Rarely there is a violation of the menstrual cycle and impotence, as well as hypothyroidism (a decrease in thyroid function).

    Prothionamide can rarely cause damage to the peripheral and central nervous systems.

    In a combination with isoniazid cases of polyneuropathy are described. Taking protionamide can cause dizziness, headaches, weakness, impaired concentration, mental disorders. Rarely, optic neuritis, tachycardia.Simultaneous reception of other antituberculosis drugs acting on the central nervous system, such as isoniazid and cycloserine, can lead to an increase in side effects from the central nervous system. The same effect can have a simultaneous reception of alcohol.

    In some cases, allergic reactions and disorders of the bone marrow are described.

    Interaction:

    With combined therapy of tuberculosis, the additive hepatotoxic effect of individual drugs should be taken into account. Particularly, combinations of a protionamide with isoniazid, rimfapicin and pyrazinamide.

    The active effect on the central nervous system is noted when isoniazid and cycloserine are combined.

    Simultaneous reception of alcohol leads to depression of the central nervous system.

    In certain cases, when taking protionamide, it is necessary to reduce the dose of insulin or oral antidiabetic drugs used for oral administration.

    Special instructions:

    It is necessary to avoid the joint use of protionamide and alcohol because of the danger of the emergence of conditions of central nervous system depression (associated with an increase in the toxic effect of alcohol).

    In the combined use of protionamide with isoniazid and cycloserine, special attention should be paid to the possibility of mental disturbance.

    Since the drug is constantly used in combination with other antituberculous drugs, regular monitoring of serum transaminases, gamma-glutamate transferase and alkaline phosphatase is necessary.

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

    Skin and especially mucous diseases of the reaction may be the first signs of pellagra-like side effects.

    This should be regarded as the reason for the necessary withdrawal of the drug.

    Form release / dosage:

    Tablets, 250 mg.

    Packaging:

    10 tablets are packed in PVC / aluminum foil blisters.

    For 100 blisters, 10 blisters and 5 blisters each, in a pack of cardboard box along with instructions for use.

    Storage conditions:

    In dry and protected from light and out of reach of children at a temperature of no higher than 25 ° C.

    Shelf life:

    3 years.

    Do not use after the time specified on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000546
    Date of registration:31.08.2010
    The owner of the registration certificate:FORTYUN MED, LTD FORTYUN MED, LTD Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.09.2015
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