Colme® (Colme®)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCyanamideCyanamide
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  • Colme®
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  • Mizo
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    LASA LABORATORIOS, LLC     Russia
    • Dosage form: & nbsp
    solution (drops) for oral administration

    Composition:

    In an ampoule of 15 ml contains the active substance: cyanamide 0.9 g (in 1 drop 3 mg).

    Excipients: sorbic acid, acetic glacial acid, sodium acetate, water for injection.

    Description:Transparent colorless solution with a faint smell of acetic acid.
    Pharmacotherapeutic group:Treatment for alcoholism
    ATX: & nbsp

    N.07.B.B   Drugs used in alcohol dependence

    Pharmacodynamics:

    The action of cyanamide is based on the blockade of acetaldehyde hydrogenase, which is involved in the metabolism of ethyl alcohol. This leads to an increase in the concentration of the metabolite of ethyl alcohol - acetaldehyde, which causes negative sensations (flushing of the face, nausea, tachycardia, dyspnea, etc.), which make the use of alcohol extremely unpleasant after taking the drug. This leads to a conditioned reflex aversion to the taste and smell of alcoholic beverages.

    The sensitization effect of cyanamide on alcohol is earlier (approximately 45-60 minutes) and lasts shorter (about 12 hours) than the action of disulfiram.Also unlike disulfiram cyanamide has no hypotonic effect.

    Indications:
    KOLME is used to treat patients with chronic alcoholism and prevent relapse.
    Contraindications:Severe heart disease, respiratory and renal disease with impaired function, severe liver disease, pregnancy, breastfeeding period, increased individual sensitivity to the drug.
    Dosing and Administration:

    Treatment is appointed after careful examination of the patient and warning of the consequences and complications. The drug is taken internally at 36-75 mg (12-25 drops 2 times a day at intervals of twelve hours) according to the individual scheme.

    For dosing, you should break the vial containing the drug solution, pour the contents into the vial enclosed in the package, and put the dropper on the vial. The bottle should be tightly closed.

    Side effects:The drug, as a rule, is well tolerated if alcohol is not used. Sometimes fatigue, drowsiness, skin rashes, tinnitus, transient leukocytosis are possible.
    Overdose:

    Symptoms are not described, there may be an increase in side effects.In case of taking too large doses of the drug, it is recommended to rinse the stomach and prescribe symptomatic treatment aimed at maintaining the functions of the liver, respiration and cardiovascular system, monitoring of the hematocrit and, if necessary, blood transfusion is also necessary.

    Reaction to alcohol

    With the simultaneous reception with alcohol, the following symptoms appear: severe skin flushing, "pulsation" in the head and neck, nausea, tachycardia, difficulty breathing, weakness, blurred vision, profuse sweating, chest pain. In the most severe cases, vomiting, lowering of arterial pressure, respiratory depression, collapoid state. The nature and severity of the symptoms depend on the amount of alcohol and drug taken. In severe cases it is necessary to carry out symptomatic therapy aimed at maintaining the functions of the respiratory and cardiovascular system, intravenous infusion of antihistamines.

    Interaction:

    KOLME should be avoided together with metronidazole, isoniazid, phenothoin and other aldehyde dehydrogenase inhibitors, which can enhance the reaction with alcohol.After taking disulfiram, before the appointment of KOLME, there should be a break of at least 10 days.

    KOLME is not compatible with aldehyde group preparations (paraldehyde and chloral products).

    Special instructions:

    KOLME should only be used under medical supervision and with the knowledge of the patient. There may be a reaction to alcohol contained in certain medicines and foods.

    Treatment of KOLME can be started only after 12 hours from the moment of the last intake of alcohol. KOLME should be used with caution in those cases when the reaction to simultaneous reception with alcohol can entail a risk to the patient's health: hyperthyroidism, diabetes, epilepsy, cardiovascular diseases, kidney diseases. At long reception it is recommended to supervise function of a thyroid gland not less often, than once in half a year.

    Form release / dosage:
    Drops for ingestion 60 mg / ml.
    Packaging:

    15 ml in ampoules made of brown glass.

    For 1 or 4 ampoules complete with a dispenser (dropper), put in a plastic cell tray, which is placed in a cardboard box with instructions for use.

    Storage conditions:

    List B.

    In a place protected from light, inaccessible to children, at a temperature not exceeding 25 ° С.

    Shelf life:2 years. Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011263 / 01
    Date of registration:26.03.2010 / 09.12.2014
    Expiration Date:Unlimited
    Date of cancellation:2016-01-25
    Manufacturer: & nbsp
    Representation: & nbspFARMLYUKS LLC FARMLYUKS LLC Russia
    Information update date: & nbsp31.01.2018
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