Perchloron® (Perhloson)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceThioureidoimiminomethylpyridinium perchlorateThioureidoimiminomethylpyridinium perchlorate
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  • Perchloron®
    pills inwards 
    FARMASINTEZ, JSC (Irkutsk)     Russia
    • Dosage form: & nbspfilm coated tablets
    Composition:
    Active substance:
    Thioureidoimiminomethylpyridinium perchlorate (Perchlorone) 200 mg, 400 mg Excipients:
    Kernel: silicon colloidal dioxide 5.0 mg / 10.0 mg, crospovidone 17.5 mg / 35.0 mg, magnesium stearate 2.5 mg / 5.0 mg, povidone 5.0 mg / 10.0 mg, cellulose microcrystalline
    60.0 mg / 120.0 mg.
    The membrane film: hypromelose E5 0.35 mg / 0.70 mg, hypromelose E15 6.0 mg / 12.0 mg, iron dye yellow oxide 0.40 mg / 0.80 mg, macrogol 6000 1.25 mg / 2, 5 mg, talcum powder
    1.0 mg / 2.0 mg, propylene glycol 0.50 mg / 1.0 mg, titanium dioxide 0.50 mg / 1.0 mg.

    Description:
    Tablets with a dosage of 200 mg: film-coated from yellow to dark yellow, round, biconvex, engraved "PHZ" on one side.
    On a cross-section the tablet is from light yellow to yellow with a weak greenish tinge.
    400 mg tablets: film-coated from yellow to dark yellow, oval, biconvex, engraved "PHZ" on one side.
    On a cross-section the tablet is from light yellow to yellow with a weak greenish tinge.

    Pharmacotherapeutic group:anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.K   Other antituberculous drugs

    Pharmacodynamics:
    Anti-tuberculosis drug.The mechanism of action is not established.
    It is active against Mycobacterium tuberculosis and Mycobacterium bovis. Has a pronounced inhibitory effect on the viability of mycobacteria tuberculosis, including those resistant to other antituberculous drugs.
    Perchlorone is a low-toxic substance, does not cause significant structural-functional disturbances of vital organs and systems, as well as irritating effects on the mucous membranes of the gastrointestinal tract.
    The mechanism of action is not definitively established, the study continues.
    Pharmacokinetics:
    After ingestion Perchloronum is quickly absorbed in the gastrointestinal tract. Time to reach the maximum concentration in the blood (TCam) - 1,5-3 hours. After a single oral intake at doses of 400 mg, 800 mg, 1200 mg and 1600 mg, the maximum concentration in the blood (C max) is 2.61 + 0.34 μg / ml, 5.07 ± 0.69 μg / ml, 5.42 +0.65 μg / ml and 8.17 + 1.91 μg / ml, respectively. The half-life is 12-27 hours. The time to establish a steady-state concentration (Css) of active substance in the blood for prolonged use is 14 days. The concentration of active substance in the blood at the course of taking the drug (1 time per day), measured 15 minutes before the next dose is 23.4 μg per 1 ml of blood plasma.
    The pathways of metabolism of the active substance are not established, the study continues.

    Indications:
    Tuberculosis of the lungs, incl. with multidrug-resistant Mycobacterium tuberculosis (as part of combination therapy).

    Contraindications:
    Hypersensitivity to the active substance or to any components of the drug, a violation of the liver and / or kidney function (the possibility of using the drug in this category of patients has not been studied), pregnancy, the period of breastfeeding, children (up to 18 years).

    Carefully:
    Elderly age.

    Pregnancy and lactation:
    The drug is contraindicated for use during pregnancy and during breastfeeding.

    Dosing and Administration:
    Inside, after meals once a day. The drug is administered to adults at the rate of 9.5-12.5 mg / kg / day: with a body weight of less than 50 kg, 400-600 mg / day; with a body weight of 50-80 kg - 800-1000 mg / day; with a body weight of more than 80 kg - not more than 1200 mg / day. The duration of therapy is up to 3 months.

    Side effects:
    From the nervous system: dizziness, headache, weakness, drowsiness, loss of consciousness, neuropsychiatric reactions (aggression, depression).
    On the part of the cardiovascular system: tachycardia, palpitation, lowering blood pressure.
    On the part of the digestive system: pain in the epigastric region, increased activity of "liver" transaminases, nausea, vomiting
    Allergic reactions: itching, rash, skin hyperemia, toxic-allergic reactions, angioedema.
    Other: bronchospasm, fever, eosinophilia, sensation of fever
    Overdose:
    Overdose
    There are no data on acute overdose when Perchloron is taken in humans.
    Treatment: a specific antidote is unknown. In case of an overdose, general supportive therapy with the control of the basic physiological parameters should be carried out. Recommended gastric lavage, the appointment of activated charcoal.

    Interaction:
    Interaction with other drugs has not been adequately studied.
    With the simultaneous use of Perchlozone with other anti-tuberculosis drugs (isoniazid, amikacin, rifabutin, rifampicin), there is an increase in activity against mycobacteria tuberculosis, while the possibility of mutual potentiation of side effects should be taken into account.

    Special instructions:
    When developing allergic reactions it is recommended to cancel the drug. To stop fever, do not use metamizol sodium (analgin). In case of development of other aforementioned adverse reactions, the possibility of reducing the dose to 400 mg / day or drug withdrawal should be considered.

    Effect on the ability to drive transp. cf. and fur:
    Impact on the ability to drive vehicles and mechanisms
    There was no special study of Perkhlozon's influence on the ability to drive and work with machinery. Such side effects of the drug as dizziness, weakness, drowsiness (see also section "Side effect"), can worsen the reactivity and ability to concentrate. During treatment with Perchlorozon, vehicle management is not recommended, as is the employment of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Tablets, film-coated 200 mg, 400 mg
    Packaging:
    Primary packaging of medicinal product.
    10 tablets are placed in a contour mesh package made of polyvinylchloride film and foil of aluminum printed lacquer. 50 or 100 tablets are placed in a polymer can with the lid of a pull-up with the control of the first opening.Free space is filled with cotton wool. Labels are applied to cans from paper label or writing or from polymeric materials, self-adhesive.
    Secondary packaging of medicinal product
    For 5 or 10 contour squares, together with the instruction for use, they are placed in a pack of cardboard for consumer packaging of subgroups chrome or chrome-ersatz, or of another similar quality. The packets are placed in a group package.
    On 1 bank together with instructions on application place in a pack from a cardboard for consumer tare. The bundles are placed in a group package - a box of corrugated cardboard.

    Storage conditions:
    In a dry, protected from light place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    2 years. Do not use after the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001899
    Date of registration:09.11.2012
    The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.09.2015
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