Universal reference book for medicines
Product name: IMOVAN ® (IMOVANE ® )

Active substance: zopiclone

Type: Soporific drug

Manufacturer: SANOFI-AVENTIS FRANCE (France) manufactured by SANOFI WINTHROP INDUSTRIE (France)
Composition, form of production and packaging
The tablets, covered with a film shell of
white color, are oval, with a risk on one side.

1 tab.

Zopiclone 7.5 mg

Auxiliary substances: wheat starch - 60 mg, calcium hydrophosphate dihydrate - 60 mg, lactose monohydrate - 31.575 mg, sodium carboxymethyl starch (type A) - 4.95 mg, magnesium stearate - 0.975 mg.

The composition of the shell *: hypromellose - 4.95 mg, titanium dioxide (E171) - 1.65 mg, macrogol 6000 - 1.65 mg.

* - a ready-made mixture can be used to apply the coating to the "Oadry Oy-S-38906" tablet - 8.25 mg (composition "Opadry OY-S-38906": hypromellose - 60%, titanium dioxide (E171) - 20%, macrogol 6000 - 20%).

10 pieces.
- blisters (2) - packs of cardboard.
20 pcs.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Sleeping drug from the group of cyclopyrrolones.
It has the following pharmacological properties: hypnotic, sedative, tranquilizing, anticonvulsant and muscle relaxant. These effects are associated with its effect on CNS receptors related to the macromolecular complex GABA, modulating the opening of channels for chloride ions.
Zopiclone has the property of reducing the time to sleep and the frequency of nocturnal awakenings, increasing the duration of sleep and improving the quality of sleep and awakening.

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

PHARMACOKINETICS

Suction

Zopiclone is rapidly absorbed.
C max in blood plasma are achieved within 1.5-2 h 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.
Distribution

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 N-desmethyl metabolite (pharmacologically inactive).
T 1/2 is approximately 4.5 and 7.4 hours, respectively.
Excretion

In recommended doses, T 1/2 of unchanged zopiclone is approximately 5 hours. In urine, zopiclone is excreted (approximately 80%), mainly in the form of metabolites, with a caloric mass of about 16%.

Pharmacokinetics in special clinical cases

In elderly patients, despite a slight decrease in metabolism in the liver and an elongation of T 1/2 to about 7 hours, no cumulation of the drug in the plasma was 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 reduction in the dimethylation process.

INDICATIONS

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

DOSING MODE

Treatment should be conducted as short as possible and not more than 4 weeks.
An extension of the treatment period is possible after a reassessment of the patient's condition. The drug is taken before bedtime.
Duration of treatment of transient insomnia - from 2 to 5 days, situational insomnia - from 2 to 3 weeks.
In chronic insomnia, the duration of the course treatment the doctor determines individually.
The recommended adult dose is 7.5 mg.
Do not exceed the indicated dose.
Treatment of elderly patients, patients with impaired liver function or with chronic pulmonary insufficiency begin with a dose of 3.75 mg and, if necessary, increase it to 7.5 mg.

In patients with renal insufficiency, it is recommended to begin treatment with a dose of 3.75 mg, despite the fact that in this pathology cumulation of zopiclone and its metabolites is not detected.

SIDE EFFECT

Most often: bitter taste in the mouth.

From the side of the central nervous system: dizziness, headache, residual drowsiness after awakening, anterograde amnesia is possible;
rarely - nightmarish dreams, irritability, confusion, hallucinations, aggressiveness, confusion, depressed mood, impaired coordination of movements, depressive state, inadequate behavior with possible development of amnesia.
On the part of the digestive system: dyspepsia, nausea, dry mouth;
in isolated cases - a slight increase in the activity of hepatic transaminases and / or AP in the blood serum.
Allergic reactions: skin itching, rash;
extremely rarely - angioedema, anaphylactic reactions.
After cessation of treatment: withdrawal syndrome, which manifests itself by various symptoms, such as ricochet insomnia, anxiety, tremor, excessive sweating, agitation, confusion, headache, tremor, tachycardia, delirium, nightmares, hallucinations, irritability;
very rarely - seizures.
CONTRAINDICATIONS

- Myasthenia gravis;

- severe respiratory failure;

severe hepatic impairment;

- sleep apnea syndrome;

- age up to 18 years;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

It is not recommended to use the drug during pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with renal failure, it is recommended to start treatment with a dose of 3.75 mg, despite the fact that in this pathology cumulation of zopiclone and its metabolites is not detected



APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Treatment of patients with impaired liver function starts with a dose of 3.75 mg and, if necessary, increases it to 7.5 mg.

Contraindicated in severe hepatic insufficiency.

APPLICATION IN ELDERLY PATIENTS

Treatment of elderly patients begins with a dose of 3.75 mg and, if necessary, increases it to 7.5 mg.

SPECIAL INSTRUCTIONS

When prescribing Imovan ®, it should be remembered that although the risk is minimal, it is impossible to completely exclude the development of addiction to zopiclone and its abuse.
The risk of dependence or abuse arises in cases of dose disruption and duration of treatment; abuse of alcohol and / or medicines; reception with alcohol or other psychotropic drugs.
The risk of developing ricochet insomnia and withdrawal syndrome after a sharp discontinuation of zopiclone intake can not be ruled out, especially after long-term treatment.
Therefore, it is recommended to gradually reduce the dose of Imovan and notify the patient about it.
Possible development of anterograde amnesia, especially with interruption of sleep or after a considerable time between taking the drug and going to sleep.
To reduce the risk of manifestation of anterograde amnesia, it is necessary to take the pill just before bedtime; ensure a sleep duration of at least 6 hours.
The drug is not indicated for the treatment of depression and can even mask its symptoms.

Use in Pediatrics

There is no safe and effective dose of Imovan ® in children and adolescents under the age of 18 years .

Impact on the ability to drive vehicles and manage mechanisms

Because of its pharmacological properties, zopiclone can degrade the ability to drive vehicles and work with mechanisms, so during the treatment period the patient should refrain from such activities.

OVERDOSE

Symptoms: a different degree of CNS depression from drowsiness to coma, depending on the amount of the drug taken.
In mild cases, there are drowsiness, confusion, apathy. In more serious cases - ataxia, arterial hypotension, respiratory depression, coma.
Overdosing does not pose a threat to life unless it is combined with the administration of other drugs that have a depressing effect on the central nervous system (including alcohol).
Other risk factors, such as concomitant disease and a weakened patient, may exacerbate symptoms and even (very rarely) cause death.
Treatment: gastric lavage is effective only if performed shortly after taking the drug.
If necessary, symptomatic and supportive therapy in a hospital is recommended.Particular attention should be paid to maintaining the respiratory and cardiovascular system. Hemodialysis is not very effective because of the large V d of zopiclone.As an antidote, flumazenil can be used.
DRUG INTERACTION

It is not recommended simultaneous reception with alcohol, tk.
it is possible to enhance the sedative effect of zopiclone.
Strengthening the oppressive effect on the central nervous system is possible with the simultaneous administration of Imovan ® with neuroleptics, hypnotics, tranquilizers, sedatives, antidepressants, opioid analgesics, antiepileptic drugs, anesthetics, antihistamines with sedative effect, and erythromycin.

Taking imovan ® reduces the concentration of trimipramine in the plasma and its effect.

With simultaneous administration of Imovan ® with inhibitors of the isoenzyme CYP3A4 (erythromycin, clarithromycin, ketoconazole, ritonavir), an increase in zopiclone concentration in plasma is possible.

With the simultaneous administration of Imovan ® with inducers of the isoenzyme CYP3A4 (including rifampicin, carbamazepine, phenobarbital, phenytoin), a decrease in zopiclone concentration in the plasma is possible.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry place inaccessible to children, at a temperature below 30 ° C.
Shelf life - 3 years.
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