Ethomide (Etomid)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceEthionamideEthionamide
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    • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet contains:

    active substance: ethionamide 250 mg;

    auxiliary substances: acacia gum 2.5 mg, gelatin 5.0 mg, starch 10.0 mg, sodium carboxymethyl starch 10.0 mg, silicon colloidal dioxide 1.0 mg, purified talc 5.0 mg, magnesium stearate 3.0 mg;

    composition of the shell: povidone 1.0 mg, hypromellose 2.5 mg, talc purified 1.25 mg, dye quinoline yellow 0.13 mg, titanium dioxide 1.25 mg, diethyl phthalate 0.72 mg.

    Description:Yellow, round, biconvex tablets, coated with a shell, with a characteristic slight specific odor.
    Pharmacotherapeutic group:Anti-tuberculosis agent.
    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. The time to reach the maximum concentration in the blood (Tcmax) is 1-3 hours. It penetrates well into tissues and organs, as well as into spinal 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:With caution - acute gastritis, peptic ulcer and duodenal ulcer, erosive-ulcerative colitis, epilepsy. Children under 3 years (for this dosage form).
    Pregnancy and lactation:contraindicated
    Dosing and Administration:

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

    Side effects:

    -of the cardiovascular system: orthostatic hypotension.

    -of the gastrointestinal tract: loss of appetite, nausea, vomiting, dry mouth or hypersalivation, "metallic" taste in the mouth, abdominal pain. 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.

    Allergic reactions - photosensitivity, thrombocytopenia, thrombocytopenic purpura. 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.

    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 - peripheral optic neuritis, diplopia, visual impairment, tachycardia.
    Overdose:No reports of cases of overdose with ethionamide have been reported. There is no special information on overdose therapy. A standard procedure for cleaning the gastrointestinal tract and symptomatic maintenance of vital functions are needed.
    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. The additive effect on the central nervous system is noted with the combined use of isoniazid andcycloserine (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 hypoglycemic drugs.

    Special instructions:

    Before treatment with ethionamide and every 2-4 weeks it is necessary to monitor activity "hepatic" translinases in the blood plasma. AT when combined with pyrazinamide requires more frequent control of liver function.

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

    Combined use with protionamide it is impractical, tk. in mycobacteria tuberculosis is cross resistance to these drugs.

    It is necessary to avoid joint admission drugs that are hepatotoxic action.

    During treatment with ethionamide it is necessary assign pyridoxine.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and mechanisms, while engaging in potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Film coated tablets of 250 mg.

    Packaging:For 10 tablets per strip of aluminum foil, 5 or 10 strips together with instructions for use in a cardboard box.
    Storage conditions:List B. In a dry, protected from light and inaccessible to children at a temperature of no higher than 25 ° C.
    Shelf life:

    4 years

    Do not apply after the period indicated on the packaging.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011943 / 01
    Date of registration:31.08.2007
    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: & nbsp06.10.2015
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