Active substancePhthivazidePhthivazide
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  • Phthivazide
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    AVEKSIMA, JSC     Russia
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  • Dosage form: & nbsppills
    Composition:

    active substance: ftivazid - 0.5 g. excipients: potato starch, calcium stearate

    Description:

    tablets from light yellow to yellow, with a faint smell of vanillin, flat-cylindrical with a risk and chamfer.

    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 breaks the synthesis of phospholipids, forms intra- and extracellular chelate complexes with divalent ions, inhibiting oxidative processes and the synthesis of RNA and DNA.

    Pharmacokinetics:

    Absorption is high. The time to reach a maximum concentration of 1-2 hours. The connection with plasma proteins is less than 10%. It penetrates the placental barrier and into the mother's milk. Metabolized in the liver with the formation of the main metabolite - hydrazide isonicotinicacid, which is further subjected to hydrolysis and acetylation. 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:

    Tuberculosis: all forms and localizations in adults and children.

    Contraindications:

    Hypersensitivity, angina pectoris, heart failure II-III st, decompensated heart diseases, epilepsy, organic lesions of the central nervous system, liver and / or kidney disease (non-tuberculosis), chronic renal failure, alcoholism, pregnancy, lactation.

    Dosing and Administration:

    Inside, the average daily dose - 1-1.5 g in 2-3 doses, children - 20-30-40 mg / kg / day in 3 doses (not more than 1.5 g / day). Higher doses for adults: single dose - 1 g, daily - 2 g. For tuberculosis lupus - 0.2-0.3 g 3-4 times a day; course dose - 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 disturbance, fatigue, depressive states, psychoses, memory disorders, euphoria, increased epileptic seizures in epileptic patients.

    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:
    Strengthens the side effects of paracetamol, ethanol, benzodiazepines, carbamazepine, hepatotoxic agents, anticoagulants, antiaggregants; reduces - mineral and glucocorticoids.
    Antacids slow down absorption.

    Special instructions:

    During the period of treatment, periodic examination of the fundus is necessary. To prevent the development of neuritis, simultaneously with the drug prescribed vitamins B1 and B6. During lactation during the treatment should stop breastfeeding. Can be used in patients with hypersensitivity to isoniazid.


    Form release / dosage:Tablets of 0.5 g
    Packaging:

    10 tablets per contour packing from polyvinylchloride film and aluminum foil foil lacquered.

    For 5 or 10 contiguous cells Packages together with the use in a pack of cardboard.

    For 500 or 1000 tablets are placed in Polymer can with lid pulled with the control of the first autopsy.

    Free space in banks filled with cotton wool hygroscopic.

    Banks, together with an equal number of instructions for use, are placed in a group package.

    Storage conditions:. In dry, sheltered from the light, at a temperature of 25grad. FROM.
    Shelf life:4 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N003468 / 01
    Date of registration:25.06.2009
    The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia
    Manufacturer: & nbsp
    Representation: & nbspPharmasynthesis, JSCPharmasynthesis, JSC
    Information update date: & nbsp29.10.2015
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