Active substanceEthionamideEthionamide
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  • Dosage form: & nbspcoated tablets
    Composition:In one tablet, 250 mg of ethionamide is contained as active ingredient, as well as auxiliary substances - microcrystalline cellulose, colloidal silicon dioxide, starch (corn), poptsdon (K-30), purified water, magnesium stearate, purified talc, sodium starch glycolate, croscarmellose sodium, WINCOAT-WT-N-1505 (yellow), dichloromethane, isopropyl alcohol.
    Description:

    Yellow, round, biconvex tablets, covered with a shell. At the break, the core is yellow.

    Pharmacotherapeutic group:Anti-tuberculosis drug
    ATX: & nbsp

    J.04.A.D   Derivatives of thiourea

    J.04.A.D.03   Ethionamide

    Pharmacodynamics:

    The anti-tuberculosis drug of the second series acts bacteriostatically (suppresses the synthesis of peptides of mycobacteria). Oppresses the growth and multiplication of mycobacterium tuberculosis with intracellular and extracellular location (including refractory and atypical forms). Strengthens phagocytosis in the focus of tuberculous inflammation, which contributes to its resorption. During treatment, the bacteriostatic activity of the drug is reduced.

    Pharmacokinetics:

    Absorption is high.Time to reach the maximum concentration in the blood (TCam) -1-3 hours. It penetrates well into tissues and organs, as well as into the cerebrospinal fluid. Metabolised in the liver. Excretion with bile - 70-80%, kidneys - 20-30% (less than 1% - unchanged).

    Indications:Treatment of all forms of tuberculosis, including, with the resistance of the pathogen to other anti-tuberculosis drugs (I series) or their intolerance, including in the complex tuberculostatic therapy.
    Contraindications:

    Hypersensitivity, pregnancy, lactation, hepatic insufficiency, acute hepatitis, cirrhosis, diabetes, chronic alcoholism.

    Carefully:Acute gastritis, peptic ulcer of stomach and duodenum, erosive-ulcerative colitis, epilepsy.
    Dosing and Administration:

    Take the drug inside after eating. Adults appoint 0.25 g 3 times a day; with good tolerability - 0.5 to 2 times a day. In patients older than 60 years with a body weight of less than 50 kg, the daily dose should not exceed 0.75 g (more often prescribed 0.25 g 2 times a day). Children are prescribed at the rate of 10-20 mg / kg of body weight per day.

    Side effects:

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

    From the gastrointestinal tract: loss of appetite, nausea, vomiting, dry mouth or hypersalivation, a "metallic" taste in the mouth. After the withdrawal of the drug, these phenomena tend to quickly pass.

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

    Skin reactions are rare, in some cases described pellagrope-like reactions in combination with violations from the central nervous system.

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

    Ethionamide can sometimes cause disturbances in the peripheral and central nervous systems. The intake of ethionamide can cause dizziness, headaches, weakness, impaired concentration, mental disorders. Rarely, optic neuritis, tachycardia.

    Interaction:

    With combined therapy of tuberculosis, the additive hepatotoxic effect of individual drugs should be taken into account. This is particularly true for the combination of ethionamide with isoniazid, rifampicin and pyrazinamide. Additive effect on the central nervous system is noted when combined with isoniazid and cycloserine (especially in patients who have a history of neurological or psychiatric disorders). In a combination with isoniazid cases of polyneuropathy are described.

    Simultaneous reception of other antituberculous drugs acting on the central nervous system, such as isoniazid or 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.

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

    Special instructions:

    Before treatment with ethionamide and every 2-4 weeks, it is necessary to monitor the activity of "liver" transaminases in blood plasma. In the case of combined use with pyrazinamide, more frequent monitoring of liver function is required.

    Before appointment, it is necessary to determine in vitro the sensitivity of a newly isolated culture Mycobacterium tuberculosis to the ethionamide.

    Combined use with protionamide is not advisable, because mycobacteria tuberculosis has a cross-resistance to these drugs.

    It should avoid joint taking drugs that have a hepatotoxic effect.

    During treatment with ethionamide, it is necessary to prescribe pyridoxine.

    Form release / dosage:

    Coated tablets, 250 mg.

    Packaging:

    10 tablets are placed in a PVC blister / Al.

    For 5, 6 or 10 blisters together with the instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 30 ° C, in a place protected from light and moisture.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N015168 / 01-2003
    Date of registration:30.06.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:Panacea Biotech Co., Ltd.Panacea Biotech Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC
    Information update date: & nbsp09.06.2018
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