Piklodorm® (Piclodorm®)

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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:

    One tablet contains:

    Active substance: zopiclone 7.5 mg. Excipients: in the core- potato starch - 17,24 mg, calcium phosphate dihydrate - 26 mg, milk sugar (lactose) - 106 mg, povidone (low molecular weight polyvinylpyrrolidone or plasdon) - 3.74 mg, refined sugar (sucrose) - 7.82 mg , magnesium stearate - 1.7 mg; in the shell - hydroxypropylmethylcellulose (hypromellose) - 3.157 mg, titanium dioxide 0.783 mg, talc 0.492 mg, polyethylene glycol (macrogol) 4000 0.568 mg.

    Description:The tablets are biconvex with a risk, covered with a film coat of white or white with a yellowish tinge. Two layers are visible on the cross-section.
    Pharmacotherapeutic group:Sleeping pills.
    ATX: & nbsp

    N.05.C.F.01   Zopiclone

    Pharmacodynamics:

    Zopiclone is a hypnotic from a group of cyclopyrrolons structurally different from benzodiazepines and barbiturates. Has a sedative and hypnotic effect.These effects are caused by the action of zopiclone on the central nervous system (CPS) receptors related to the macromolecular gamma-aminobutyric acid complex (GABA) and activation of the channels for chloride ions, resulting in an increase in the inhibitory effect of GABA and inhibition of interneuronal transmission in various parts of the central nervous system. It has the ability to shorten the period of falling asleep, to reduce the frequency of nocturnal awakenings, to prolong the duration of sleep, and to improve the quality of sleep and awakening. Virtually does not cause post-somnolent disorders: there is no feeling of weakness and drowsiness on the morning of the next day.

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

    Pharmacokinetics:

    Quickly absorbed in the gastrointestinal tract. The maximum concentration in the blood plasma is reached within 0.5-1.5 hours and is about 30 and 60 ng / ml after ingestion of 3.75 mg and 7.5 mg, respectively. After 1 hour after ingestion, 95% of the drug is absorbed. Absorption of the drug does not depend on the intake of food. The connection with plasma proteins is about 45%.Easily penetrates through the histohematological barriers; Do not cumulate.

    The main metabolites are N-oxide (active) and N-desmethyl metabolite. The elimination half-life (T1) is about 4.5 and 7.4 hours respectively. In recommended doses T'A unchanged zopiclone is approximately 5 hours. It is excreted in urine (approximately 80%), mainly in the form of metabolites, as well as with exhaled air, caloric masses.

    Individual groups of patients

    Mild and moderate renal dysfunction does not cause significant changes in the zopiclone kinetics; with pronounced renal failure, it is possible to increase the area under the plasma concentration-time curve (AUC), the time to reach the maximum concentration, and T1.

    ½ slightly increases also in elderly patients.

    In patients with cirrhosis of the liver, zopiclone clearance decreases by approximately 40% in accordance with a decrease in the demethylation process.

    Indications:Treatment of transient, situational and chronic insomnia in adults of various etiologies (including difficulty falling asleep, night and early awakenings).
    Contraindications:

    Hypersensitivity to zopiclone, other components of the drug; severe myasthenia gravis; severe respiratory failure; severe hepatic impairment; syndrome of "sleepy" apnea; pregnancy; lactation period; age to 18 years (efficacy and safety of use in children and adolescents have not been adequately studied).

    Dosing and Administration:

    Inside for 30-40 minutes before the proposed sleep. The recommended dose is 7.5 mg (1 tablet) per day. The maximum daily dose is 15 mg. Treatment should be as short as possible and not exceed four weeks. Elongation of treatment periods above the maximum allowable is performed after a second assessment of the patient's condition. Treatment of elderly patients and patients with impaired liver function starts with a dose of 3.75 mg (1/2 tablet) and, if necessary, increases to 7.5 mg per day.

    Although in the cases of renal failure cumulation of zopiclone and its metabolites was not found, in such patients it is recommended to start treatment with a dose of 3.75 mg.

    Side effects:

    From the digestive system: often - bitter or "metallic" taste in the mouth; nausea, vomiting, dry mouth.

    From the side of the central nervous system: headache, dizziness, residual drowsiness after waking up; more often in elderly patients - aggressiveness, confusion, increased excitability, depression, hallucinations, nightmares and anterograde amnesia; rarely - euphoria, a violation of coordination of movements. When the drug is discontinued, a "cancellation" syndrome (frequent awakening, the resumption of insomnia) is possible, and after prolonged use, drug dependence may develop.

    Allergic reactions: urticaria, skin rash.

    Overdose:

    Symptoms: oppression of the central nervous system of various severity (from drowsiness to coma), ataxia, rarely - atrioventricular block

    Treatment: gastric lavage if the diagnosis of an overdose is established soon after taking the drug. Symptomatic and supportive therapy in a hospital. Particular attention should be given to respiratory and cardiovascular functions. As an antidote, a benzodiazepine receptor antagonist can be used - flumazenil. Carrying out of hemodialysis is inexpedient.

    Interaction:

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

    Strengthening of oppressive influence on the central nervous system can occur in cases of concomitant administration 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.

    Special instructions:

    When prescribing the drug, it must be remembered that, although the risk is minimal, one can not completely exclude the development of addiction. The risk of dependence develops in the following cases:

    • exceeding recommended doses and duration of treatment;
    • simultaneous use with alcohol or other psychotropic drugs;
    • prescribing patients with a history of excessive consumption of alcohol and / or dependence on drugs.

    The risk of developing ricochet insomnia and withdrawal syndrome after a sharp discontinuation of Piklodorma® treatment can not be ruled out, especially after long-term treatment, so sudden cessation of treatment should be avoided.It is necessary to implement the abolition of the drug gradually.

    Anterograde amnesia can be observed, especially with interruption of sleep or with a long period of falling asleep. To reduce the risk of manifestations of anterograde amnesia, it is necessary to take the pill just before bedtime and provide a sleep duration of at least 6 hours.

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

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

    During the treatment period, it is necessary to refrain from driving vehicles and taking other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

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

    10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. 1 or 2 contour squares, together with instructions for use, are placed in a pack of cardboard.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000132
    Date of registration:11.01.2011
    Date of cancellation:2016-11-22
    The owner of the registration certificate:BINNOFARM, CJSC BINNOFARM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.11.2016
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