Active substancePyrazinamidePyrazinamide
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  • Dosage form: & nbsppills
    Composition:

    For one tablet:

    active substances: pyrazinamide - 500 mg;

    Excipients: corn starch - 45.0 mg, povidone 3.0 mg, silicon dioxide colloid 2.0 mg, sodium carboxymethyl starch (type A) 10.0 mg, talc purified 3.0 mg, magnesium stearate 3.0 mg.

    Description:Round flat tablets are white or almost white with a bevel on both sides and a risk on one side.
    Pharmacotherapeutic group:Anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.K.01   Pyrazinamide

    Pharmacodynamics:Pyrazinamide is a synthetic antituberculous agent. Has a bacteriostatic or bactericidal effect depending on the concentration and sensitivity of the microorganism, is more active in tuberculostatic activity than PASC, although inferior to isoniazid, streptomycin, rifampicin. It operates on mycobacteria, resistant to other anti-tuberculosis drugs of the II series. The drug penetrates well into the centers of tuberculous lesion. Its activity does not decrease in the acidic environment of caseous masses, and therefore it is often prescribed for caseous lymphadenitis, tuberculomas and caseous-pneumonic processes.
    Pharmacokinetics:

    Pyrazinamide is well absorbed from the gastrointestinal tract. After ingesting an adult dose of 500mg, a peak concentration of pyrazinamide in the blood plasma within 9-12 μg / ml is achieved within 2 hours, 7 μg / ml after 8 hours and 2 μg / ml after 24 hours.

    Pyrazinamide penetrates the tissues and body fluids, including the liver, lungs, cerebrospinal fluid. Approximately 50% binds to plasma proteins. The half-life is 9-10 hours for those patients whose liver and kidney function are not impaired.Within 24 hours about 70% of the oral dose is excreted by the kidneys. About 4-14% of the dose is released unchanged. The residues are excreted as metabolites.

    Indications:

    It is used to treat tuberculosis.

    In combination with other anti-tuberculosis drugs are prescribed in the following cases:

    - pulmonary tuberculosis;

    - tuberculous meningitis;

    - tuberculosis of bones;

    urogenital tuberculosis.

    Contraindications:

    - Individual intolerance;

    - liver disease;

    - gout;

    - Hyperuricemia;

    - Pregnancy, lactation;

    - Children's age up to 3 years.

    Dosing and Administration:

    The drug is used inside during or after a meal, once a day, preferably at breakfast, with a little water.

    Adults appoint 25-30 mg / kg body weight, which corresponds to those with a body weight of less than 50 κg-1.5 g and for individuals with a body weight of more than 50 kg - 2 g.

    The maximum daily dose is 2.5 g.

    In case of unsatisfactory portability Pyrazinamide appoint 2-3 reception. In elderly and elderly people, the daily dose of pyrazinamide should not exceed 15 mg / kg of body weight. In these cases, the drug should be administered every other day.

    Children are prescribed 15-20 mg / kg once a day (maximum to 1.5 g per day).

    Pyrazinamide is used in combination with aminoglycosides (streptomycin or kanamycin in a dose of 1 5 mg / kg), isoniazid (10 mg / kg), rifampicip (10 mg / kg).

    The course of treatment is 3 months.

    Side effects:

    From the gastrointestinal tract: nausea, vomiting, diarrhea, lack of appetite, unpleasant metallic taste in the mouth, epigastric pain. Violation of the function of the liver.

    From the central nervous system: with prolonged use of headache, dizziness, increased excitability, depression, sleep disturbance, weakness; in some cases - confusion, hallucinations, convulsions;

    On the part of the organs of hematopoiesis and the system of hemostasis: thrombocytopenia, sideroblastic anemia, erythrocyte vacuolization, porphyria, hypercoagulation, splenomegaly;

    From the side of the musculoskeletal system: myalgia;

    From the urinary system: dysuria, interstitial nephritis;

    Other: hyperthermia, acne, increased serum iron concentration.

    Possible allergic reactions, arthralgia, hyperuricemia, exacerbation of gout, photosensitivity.There is evidence of a delay in the body under the influence of pyrazinamide, uric acid, and possibly the appearance of arthritic pain in the joints. Therefore, it is advisable to monitor the activity of hepatic transaminases and the content of uric acid in the blood regularly (at least once a month).

    Possible development of hypoglycemia in patients with diabetes mellitus.

    With prolonged use may have toxic effects on the liver.

    Overdose:

    Overdose Symptoms: nausea, vomiting, abdominal pain, jaundice, increased liver enzymes, acute pulmonary edema, impaired consciousness, coma, convulsions, respiratory failure, hyperglycemia, metabolic ketoacidosis.

    Treatment: gastric lavage with the introduction of activated carbon, forced diuresis, general measures to maintain vital functions, hemodialysis.

    Interaction:

    Pyrazinamide is combined with other anti-tuberculosis drugs. In particular, with chronic destructive forms it is recommended to combine it with rifampicin (pronounced effect) or ethambutol (better tolerability).

    The likelihood of developing a hepatotoxic effect of the drug is increased when combined with rifampicamp.With simultaneous application with probenecid, a decrease in excretion and, consequently, an increase in toxic reactions is possible.

    Form release / dosage:Tablets of 500 mg.
    Packaging:

    For 10 tablets per blister (PVDC / aluminum).

    10 blisters with instructions for use are placed in a pack of cardboard.

    When packaged in a Russian company (FGBICU "RNTS named after NN Blokhin" or CJSC "Rafarma"), 10 blisters are placed in a pack of cardboard together with instructions for use.

    Storage conditions:

    List B.

    In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:5 years. Do not use the product after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013050 / 01
    Date of registration:25.12.2007 / 09.12.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:McLeodz Pharmaceuticals Co., Ltd. McLeodz Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspAdvansd Trading, OOOAdvansd Trading, OOO
    Information update date: & nbsp01.04.2018
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