Thorson® (Torson®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceZopicloneZopiclone
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    • Dosage form: & nbspFilm-coated tablets.
    Composition:

    Active substance: zopiclone 3.75 mg or 7.5 mg; Excipients: cellulose microcrystalline 21.0 mg / 34.7 mg, lactose 49.6 mg / 81.2 mg, starch 1.60 mg / 2.60 mg, sodium carboxymethyl starch 2.40 mg / 1.30 mg, talc 0.80 mg / 1.30 mg, magnesium stearate 0.80 mg / 1.30 mg; Film Sheath: hypromellose (HPMC 6 cps) 0.73 mg / 1.21 mg, propylene glycol 0.072 mg / 0.112 mg, titanium dioxide 0.47 mg / 0.780 mg, talc 0.29 mg / 0.490 mg, iron oxide red 0.019 mg / 0.032 mg .

    Description:

    A round, biconvex tablet covered with a film sheath, from light pink to pink with a brownish tinge.

    Pharmacotherapeutic group:Sleeping pills.
    ATX: & nbsp

    N.05.C.F.01   Zopiclone

    Pharmacodynamics:

    Zopiclone is a hypnotic from the group of cyclopyrrolones. Has a hypnotic, sedative, tranquilizing, anticonvulsant and muscle relaxant actions.

    Zopiclone is an agonist of benzodiazepine receptors. Interacts with the central receptors of the macromolecular GABA-benzodiazepine-chloro-ionophore complex, not interacting with peripheral benzodiazepine receptors.Increases the sensitivity of GABA-receptors to the neurotransmitter (GABA). This facilitates the penetration of chloride ions inside through the cytoplasmic membrane of the neurons. As a result, there is an increase in the inhibitory effect of GABA and the inhibition of interneuronal transmission in various parts of the central nervous system. The drug reduces the time to sleep and the frequency of nocturnal awakenings. An important feature of the drug is its ability to maintain the normal phase structure of sleep.

    Adapting to the hypnotic effect of the drug is absent for a long period of treatment, up to 17 weeks.

    Pharmacokinetics:

    Absorption

    Zopiclone is rapidly absorbed. The maximum concentrations in the blood plasma are achieved within 1.5-2 hours and are approximately 30 and 60 ng / ml after ingestion of 3.75 mg and 7.5 mg, respectively. Absorption of the drug does not depend on sex, nor on food intake. The connection with plasma proteins is approximately 45%.

    Metabolism

    After repeated administration of cumulation zopiclone and its metabolites do not occur. Individual differences are insignificant.

    The main metabolites are the N-oxide derivative (pharmacologically active) and the N-desmethyl metabolite(pharmacologically inactive). The half-life is approximately 4.5 and 7.4 hours, respectively.

    At recommended doses, the half-life of unchanged zopiclone is approximately 5 hours. With urine zopiclone (approximately 80%), mainly in the form of metabolites, with a caloric mass of about 16%.

    Individual groups of patients

    In elderly patients, despite a slight decrease in metabolism in the liver and an elongation of the half-life to about 7 hours, the cumulation of the drug in plasma was not detected even after repeated administration.

    In patients with renal insufficiency, cumulation of zopiclone or its metabolites was not detected even after prolonged use.

    In patients with liver cirrhosis, the zopiclone clearance is reduced by approximately 40% in accordance with the dimethylation process.

    Indications:

    Treatment of transient, situational and chronic insomnia in adults (including difficulties with falling asleep, night and early awakenings).

    Contraindications:

    • hypersensitivity to zopiclone or other components of the drug;
    • severe myasthenia gravis;
    • severe respiratory failure;
    • severe hepatic impairment;
    • syndrome of "sleepy" apnea;
    • pregnancy and the period of breastfeeding;
    • age to 18 years.

    Carefully:Liver failure.
    Pregnancy and lactation:

    It is not recommended to use the drug during pregnancy and prescribe to nursing mothers.

    Dosing and Administration:

    Inside. The recommended period of treatment with the drug is up to 4 weeks. Longer use of zopiclone is possible after an additional assessment of the patient's condition. The drug is taken before bedtime.

    Duration of treatment.

    Transient insomnia: 2 to 5 days.

    Situational insomnia: 2 to 3 weeks.

    Chronic insomnia: the duration of the course of treatment is determined after consultation with a specialist.

    The recommended adult dose is 7.5 mg, if necessary and with tolerability, up to 15 mg (maximum dose). Treatment of elderly patients and patients with impaired liver function or chronic pulmonary insufficiency begin with a dose of 3.75 mg and, if necessary, increase to 7.5 mg.

    Although in cases of renal failure cumulation of zopiclone and its metabolites was not found, in such patients the recommended maximum daily dose of 3.75 mg.

    Side effects:

    The most frequent side effect observed when zopiclone is prescribed is a bitter taste in the mouth, can also be:

    • dizziness, headache, residual drowsiness after waking up;
    • digestive disorders: dyspepsia, nausea, dry mouth;
    • allergic skin reactions such as itching and eruptions, angioedema and anaphylactic reactions are extremely rare.

    Anterograde amnesia can occur.

    Mental and paradoxical reactions

    Rarely: nightmares, irritability, confusion, hallucinations, aggressiveness, confusion, depressed mood, impaired coordination of movements, depressive state, inadequate behavior with possible development of amnesia.

    The syndrome of "cancellation" and ricochet insomnia are observed after discontinuation of treatment. Single cases of a slight increase in serum transaminases and / or alkaline phosphatase were noted.

    Overdose:

    Overdose usually manifests itself in the form of symptoms of varying degrees of depression of the central nervous system from drowsiness to coma, depending on the amount of the drug taken. The first help consists in washing the stomach, taking activated charcoal.If necessary, symptomatic and supportive therapy in a hospital is recommended. Particular attention should be given to respiratory and cardiovascular functions.

    Hemodialysis is of low significance because of the large volume distribution of zopiclone. Flumazenil can be used as an antidote.

    Interaction:

    It is not recommended simultaneous reception with alcohol, since the sedative effect of zopiclone may intensify.

    Strengthening of oppressive influence on the central nervous system can occur in cases of simultaneous appointment with neuroleptics, hypnotics, tranquilizers, sedatives, antidepressants, narcotic analgesics, antiepileptic drugs, anesthetics, antihistamines with sedative effect, and erythromycin.

    Taking the drug reduces the concentration of trimipramine in the plasma and its effectiveness
    Special instructions:

    When appointing Torson®, it must be remembered that although the risk is minimal, it is impossible to completely exclude the development of addiction and abuse of the drug.

    The risk of dependence or abuse arises in the following cases:

    • dose and duration of treatment;
    • abuse of alcohol and / or medicines;
    • use with alcohol or other psychotropic drugs.

    Reflective insomnia and withdrawal syndrome.

    The risk of such events after the abrupt discontinuation of Torson® can not be ruled out, especially after long-term treatment. Therefore, it is recommended to gradually reduce the dosage and notify the patient about it.

    Amnesia

    Anterograde amnesia can occur, especially with interruption of sleep or after a considerable time between taking the drug and going to sleep. To reduce the risk of anterograde amnesia:

    • take the pill just before bedtime;
    • ensure a sleep duration of at least 6 hours.

    Depression

    The drug is not indicated for the treatment of depression, and can even mask its symptoms.

    Use in children

    A safe and effective dose of zopiclone has not been established in children and young people under the age of 18 years.

    Effect on the ability to drive transp. cf. and fur:

    Due to its pharmacological properties, Torson® can have an adverse effect on the ability to drive and control transport, so during treatment it is necessary to refrain from this.

    Form release / dosage:Tablets, film-coated 3.75 mg, 7.5 mg.
    Packaging:

    10 tablets in a strip of aluminum foil. 1, 2, 3. 4, 5, 6, 7, 8, 9 or 10 strips with instructions for use in a cardboard box.

    Storage conditions:

    Store in a dry place at a temperature not exceeding 30 ° C. Keep out of the reach of children.


    Shelf life:

    2 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001360/08
    Date of registration:29.02.2008
    The owner of the registration certificate:TORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India
    Manufacturer: & nbsp
    Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India
    Information update date: & nbsp16.10.2015
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