Elenium® (Elenium®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceChlordiazepoxideChlordiazepoxide
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  • Elenium®
    pills inwards 
    Tallinn Pharmaceutical Factory     Estonia
    • Dosage form: & nbspCoated tablets
    Composition:

    active substance:

    Chlordiazepoxide 10 mg -

    Excipients:

    Potato starch 5.5 mg

    Gelatin - 2.4 mg

    Polysorbate 80 (Tween 80) - 0.1 mg

    Talc - 1.4 mg

    Magnesium stearate - 0.7 mg

    Lactose 53.9 mg

    Sodium starch glycollate - 1.0 mg

    shell:

    Polyvinyl alcohol - 0.078 mg

    Talc - 5.888 mg

    Maltodextrin - 0.183 mg

    Sugar - 18.294 mg

    varnish green E132 + E104 0,189 mg

    Titanium Dioxide 0,378 mg

    Description:

    The tablets are coated with a green color, on a broken white color, round, convex on both sides, without spots, defects and cracks.

    Pharmacotherapeutic group:Anxiolytic agent
    ATX: & nbsp

    N.05.B.A.02   Chlordiazepoxide

    Pharmacodynamics:

    The drug belongs to the list of psychotropic substances (List III). Elenium belongs to the group of benzodiazepine derivatives. The mechanism of action of the drug is associated with the inhibitory endogenous neurotransmitter gamma-aminobutyric acid (GABA) and GABA-A receptors, through which the neurotransmitter realizes its effects in the central nervous system. Like all other benzodiazepines, Elenium enhances the inhibitory effect of GABA-ergic neurons of the cerebral cortex, hypocampus, cerebellum, spinal cord and other structures of the central nervous system.Clinically, Elenium exerts an anxiolytic, hypnotic, sedative, central miorelaxing and anticonvulsant action.

    Pharmacokinetics:

    Suction

    After oral administration, Elenium is well absorbed from the digestive tract.

    The maximum concentration of the drug in the blood serum (Cmah) is achieved after 2 hours and is 0.76 - 2.05 μg / ml. Equilibrium concentration in the blood serum (stationary phase) the drug reaches within 3 days.

    Distribution

    The drug in 96% binds to blood proteins. Penetrates through the blood-brain barrier, placental barriers and into the mother's milk.

    Metabolism

    Elenium undergoes biotransformation in the liver to pharmacologically active metabolites, which prolong the duration of the drug. The main metabolites are: desmethylchlorodiazepoxide and demoxepam.

    Half-life of the drug from blood serum (tm) is 6-30 hours (the period of elimination of active metabolites is much longer and is several days). In patients with renal insufficiency Elenium half-life may be prolonged.

    Allocation

    Elenium and its metabolites are excreted in urine; about 1 - 2% of the drug is excreted unchanged.

    Indications:

    state of anxiety and fear

    state of excitement with abstinent alcohol syndrome

    sleep disorders accompanied by anxiety and fear.

    states of increased stress of skeletal muscles of various origins

    for premedication: preparation for long-term diagnostic procedures and operations.

    Contraindications:

    - individual drug intolerance

    - disorders of central respiration and severe respiratory failure regardless of the cause

    - acute kidney and liver diseases

    - renal insufficiency

    - alcohol intoxication

    - oppression of the central nervous system by various substances

    - myasthenia gravis

    - closed-angle glaucoma

    - impaired consciousness

    Do not use in children under 4 years.

    Pregnancy and lactation:

    The use of the drug during pregnancy is allowed only if its use by the mother has absolute indications, and the use of a safer alternative is impossible or contraindicated.

    When treating Elenium, do not breast-feed. If it is necessary to use the drug in the mother, breastfeeding should be interrupted.

    Dosing and Administration:

    Dosage and duration of treatment should be selected individually for each patient in order to obtain the maximum effects of treatment.

    The following doses are usually used:

    Adults

    state of fear and anxiety

    5 - 10 mg 3-4 times a day, up to 30-40 mg / day, in severe conditions the dose of the drug can be increased to 20-25 mg 3-4 times a day (up to 100 mg / day);

    excitation conditions with abstinence alcohol syndrome

    at the beginning of treatment 50 - 100 mg. If necessary, the dose of the drug can be increased to a maximum of 300 mg / day. Then the dose should be gradually reduced.

    sleep disorders accompanied by anxiety and fear

    10 - 20 mg before bedtime

    states of increased stress of skeletal muscles of various origins

    10-30 mg / day in divided doses

    preparation for long-term diagnostic procedures and operations

    the day before the operation or diagnostic procedure, prescribe 5-10 mg 3-4 times a day.

    The maximum daily dose: up to 100 mg / day in divided doses (state of anxiety and fear):

    with alcohol withdrawal syndrome - up to 300 mg / day in divided doses.

    Children

    The drug should not be used in children under 4 years of age. Treatment should begin with low doses.Children aged 4-7 years - 5-10 mg / day; 8-14 years - 10-20 mg / day; 15-18 years - 20-30 mg / day; frequency of application 3-4 times / day.

    Patients of advanced age (over 65 years)

    It is recommended to reduce the dose. Usually 5 mg 2 - 4 times a day.

    Patients with impaired liver and kidney function.

    With caution, prescribe the drug to patients with impaired liver function and kidney function. You may need to reduce the dose of the medicine. The duration of treatment is usually 4 weeks (including the time of a gradual decrease in the dose of the drug). Do not take the drug for more than 4 weeks without reassessing the need for continued therapy.

    You can not abruptly cancel the drug, it is always necessary to gradually control the doctor, reducing the dose. Sharp cancellation of Elenium can lead to sleep and mood disorders, and even to mental disorders. Especially dangerous is the abrupt reversal of long-term therapy or therapy requiring large doses of the drug. The symptoms of withdrawal are more pronounced.

    Side effects:

    The most common undesirable effect, during drug treatment, are: drowsiness, impaired coordination of movements and balance, disorientation.They usually appear in elderly patients. A corresponding decrease in dose, in patients of this age group, significantly reduces the incidence of side effects.

    In addition, there may be:

    - dizziness

    - tachycardia

    - bronchorrhea, bronchospasm

    - retention of urine

    - skin allergic reactions

    - edema

    - menstrual disorders in women

    - disorders of the gastrointestinal tract (nausea, intestinal colic, constipation, diarrhea)

    - decreased or increased libido

    - fainting

    Very rarely there can be:

    - from the hematopoietic system: agranulocytosis, thrombocytopenia,

    icterus of skin

    - paradoxical reactions (fear, states of psychomotor agitation, insomnia).

    Overdose:

    As a result of an overdose of Elenium, the following symptoms may appear: drowsiness, a state of disorientation, indiscriminate speech, and in severe cases, loss of consciousness and coma.

    In acute poisoning it is necessary to empty the stomach (vomiting, gastric lavage).

    Treatment for an overdose of Elenium is primarily symptomatic and consists in monitoring the basic vital functions (breathing, pulse, blood pressure).

    A specific antidote is flumazenil (a benzodiazepine receptor antagonist).

    Interaction:

    Pharmaceutical

    Pharmaceutical types of incompatibility are not defined

    Pharmacodynamic

    The oppressive effect of Elenium on the central nervous system is strengthened by all drugs with a similar effect, for example. Barbiturates, drugs that lower the arterial pressure of the central action, antipsychotic drugs, antidepressants, anticonvulsant drugs, narcotic analgesics, hypnotics. A similar effect is exerted by ethyl alcohol. The use of alcohol during Elenium treatment, in addition to the summarizing depressing effect on the central nervous system, can provoke paradoxical reactions: psychomotor agitation, aggressive behavior.

    The drug enhances the effect of the agents that reduce skeletal muscle tone.

    Pharmacokinetic

    Rifampicin can accelerate the metabolism of Elenium and weaken its action. Cimetidine can inhibit the metabolism of Elenium and strengthen its action.

    Smoking can weaken the action of Elenium.

    Special instructions:

    In case of paradoxical reactions, the treatment should be stopped immediately.Prolonged use of chlordiazepoxide leads to a gradual weakening of the drug as a result of the development of the phenomenon of tolerance. Long-term use of the drug contributes to the development of psychophysical drug dependence and withdrawal syndrome in the event of a sharp withdrawal of chlordiazepoxide. The abstinence syndrome is characterized by psychomotor agitation, fear, autonomic disorders and insomnia.

    During treatment with chlordiazepoxide and within 3 days after its completion, you should not drink any alcoholic beverages.The drug should be used strictly according to the doctor's prescription in order to avoid complications.
    Effect on the ability to drive transp. cf. and fur:

    During treatment with the drug and within 3 days after its completion, it is impossible to drive vehicles, maintain moving mechanical devices and perform work requiring special attention and quick response.

    Form release / dosage:coated tablets, 10 mg
    Packaging:The drug is packed into 25 tablets in blister (PVC / aluminum). Two blisters with instructions for use are individual cardboard box, equipped with control stickers of the first autopsy.
    Storage conditions:

    Store at temperatures up to 25 ° C. Protect from light and moisture. Store in places inaccessible to children. The drug belongs to the list of psychotropic substances (List III).

    Shelf life:

    4 years Before using the drug, it is necessary to check the expiry date indicated on the package. The drug can not be used later than the date indicated on the packaging.

    Terms of leave from pharmacies:On prescription
    Registration number:P N015067 / 01-2003
    Date of registration:13.08.2008
    The owner of the registration certificate:Tallinn Pharmaceutical FactoryTallinn Pharmaceutical Factory Estonia
    Manufacturer: & nbsp
    Representation: & nbspFARMEXPERT LLCFARMEXPERT LLCRussia
    Information update date: & nbsp27.09.2015
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