Phthivazide (Ftivazide )

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePhthivazidePhthivazide
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    FARMASINTEZ, JSC (Irkutsk)     Russia
  • Phthivazide
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    AVEKSIMA, JSC     Russia
  • Phthivazide
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    ROSFARM, LLC     Russia
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    UZOLE-SIBERIAN CHEMICAL PLANT, OJSC     Russia
  • Phtivazide MS
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    MEDISORB, CJSC     Russia
    • Dosage form: & nbsppills
    Composition:

    Composition per one tablet, mg


    Active substance




    Phtivazide monohydrate

    100,0

    300,0

    500,0

    Excipients:



    Carboxymethyl starch -

    sodium

    2,0

    6,0

    10,0

    Potato starch -

    7,0

    21,0

    35,0

    Calcium stearate

    1,0

    3,0

    5,0


    Description:

    Tablets of light yellow or yellow color, with a weak smell of vanillin, flat-cylindrical with a risk and a facet.

    Pharmacotherapeutic group:Anti-tuberculosis drug.
    ATX: & nbsp

    J.04.A.C   Derivatives of isonicotinic acid hydrazide

    Pharmacodynamics:

    Anti-tuberculosis, acts bactericidal. It blocks the synthesis of mycolic acid (it ensures the acid resistance of mycobacteria tuberculosis) and causes cell death. It disrupts the synthesis of phospholipids, forms intra- and ex-tracellular chelate complexes from divalent ions, inhibiting oxidative processes and the synthesis of deoxy- and ribonucleic acids.

    Pharmacokinetics:

    Absorption is high. The maximum concentration in the blood plasma is achieved in 1-2 hours.Link with plasma proteins - less than 10% Penetrates through the placental barrier and into the mother's milk. It is metabolized in the liver with the formation of the major metabolite - hydrazide, isonicotinic acid, subsequently subjected to hydrolysis and acetylation. The half-life is 2-5 hours. It is excreted by the kidneys (95% in the form of metabolites), a small amount - by the intestine.

    Indications:Ttuberculosis: all forms and localizations in adults and children
    Contraindications:

    Hypersensitivity, angina pectoris, chronic heart failure II - III st. (Including on the background decompensated heart disease), epilepsy, organic lesions of the central nervous system (CNS) disorders, liver disease and / or kidney (tubercular character), chronic renal failure, alcoholism, pregnancy, lactation period (at the end of treatment breast-feeding). Children up to 1 year.

    Dosing and Administration:

    Assign into adults, the average daily dose - 1-1.5 g in 2-3 doses, children - 20-30-40 mg / kg / day in 3 doses (less than 1.5 g / d). Higher doses for adults: single dose - 1 g, daily - 2 g.

    With tuberculosis lupus - 0.2-0.3 g 3-4 times a day; the course dose is 40-60 g.If necessary, the course of treatment is repeated 3-4 times with a break in 1 month.

    Side effects:

    From the nervous system: headache, dizziness, cardialgia, sleep disorders, fatigue, depressive states, psychoses, memory disorders, euphoria, increased epileptic seizures in patients with epilepsy.

    From the sense organs: peripheral neuritis and optic neuritis.

    On the part of the digestive system: nausea, vomiting, dry mouth, decreased appetite, gastralgia, hepatitis.

    Allergic reactions - fever, skin rashes.

    Other: increased bleeding, gynecomastia, menorrhagia, arthralgia.

    Interaction:

    Increases the side effects of paracetamol, ethanol, benzodiazepines, carbamazepine, hepatotoxic drugs, anticoagulants and antiplatelet agents, reduces - in mineral and glucocorticoids.

    Antacids slow the absorption of the drug.

    Special instructions:

    During the period of treatment, periodic examination of the fundus is necessary.

    To prevent the development of neuritis with a drug prescribed thiamine and pyridoxine.

    Can be used in patients with hypersensitivity to isoniazid.

    Form release / dosage:Tablets of 100 mg, 300 mg and 500 mg.
    Packaging:

    10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.
    10 tablets per contour non-jawed packaging made of packaging material combined on a paper basis.
    For 50, 60, 70, 100, 150 tablets in a jar of polymer materials.
    By 5, 6 contour-cell packings with instructions for medical use put in a pack of cardboard.

    100 cans of polymer materials or 1000 contour mesh or 500 cells cell-free packages with equal number of medical application is placed in a group package (for hospitals).


    Storage conditions:

    In a dry, sheltered from the world place, with temperature not higher than 25 ° ะก.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002411 / 01
    Date of registration:20.05.2009
    The owner of the registration certificate:AVEKSIMA, JSC AVEKSIMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.10.2015
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