Levana tablets 0.0005 №20

Description

Levana Composition
Active substance

1 tablet contains 0.5 mg, 1 mg or 2 mg of levan [mono- [7-bromo-2-oxo-5- (2-chlorophenyl) -2,3-dihydro-1H-benzo [1,4 ] diazepin-3-yl] succinate monohydrate);

Excipients

lactose monohydrate, potato starch, calcium stearate, gelatin, dyes “Yellow West” FCF (E 110) – for a dosage of 0.5 mg, “Purple” (ponso 4R (E 124) + indigo carmine (E 132) – for a dosage of 1 mg).
Levana Release form

10 tablets in a blister; 2 blisters (for a dosage of 0.5 mg) and 1 blister (for a dosage of 1 mg and 2 mg) in a pack.
Levana Dosage form

Tablets.

Main physical and chemical properties: tablets of pale orange (dosage 0.5 mg), pale purple (dosage 1 mg) and white (dosage 2 mg), flat-cylindrical shape, beveled and risky; on one side of the tablet is the trademark of the enterprise.

Levana Pharmacodynamics

The drug is a partial (incomplete) selective agonist of GABA A-receptor complex. It belongs to the group of benzodiazepine derivatives. Has a pronounced hypnotic, anxiolytic, moderate muscle relaxant and anticonvulsant effect; enhances the effect of sleeping pills, narcotic and neuroleptic drugs, ethyl alcohol. The peculiarity of the hypnotic effect of the drug is the ability to increase the duration of not only slow-wave, but also paradoxical sleep with a constant number of episodes, which makes the hypnotic effect of the drug more physiological.
Pharmacokinetics
The drug is rapidly absorbed in the gastrointestinal tract, bioavailability is about 80%, the half-life is 10 – 14 hours (the drug can be attributed to the means of medium duration of action). Excreted by the renal and biliary tract in the form of an active metabolite – 3-oxy derivative.

Indications
Sleep disorders of various etiologies in adults.

Contraindications
Hypersensitivity to any of the components of the drug.

– severe chronic respiratory failure;

– sleep apnea syndrome (apnea);

– severe hepatic failure;

– spinal and cerebellar ataxia; acute alcohol poisoning, sleeping pills, painkillers or psychotropic drugs (antidepressants, neuroleptics, lithium);

– severe myasthenia gravis; acute attacks of glaucoma (narrow-angle glaucoma).

Pregnancy and breastfeeding. Childhood.

Interaction with other drugs
Alcohol should not be consumed during the use of the drug due to the possibility of psychomotor inhibition and respiratory depression. The drug should not be combined with phenothiazine neuroleptics due to potentiation of the depressant effect on respiration. It should be noted that cimetidine can increase the concentration of benzodiazepines (except oxazepam and lorazepam) in the blood by 50%, slowing down their metabolism and clearance. High doses of caffeine, including in beverages, can reduce the therapeutic effect of the drug.

Methods of application

Apply internally. Take without chewing. The drug should be taken once 30 – 60 minutes before bedtime.

A single dose is 0.5 – 2 mg (set individually, starting with a minimum dose of 0.5 mg, until a therapeutic effect). The maximum single and daily dose is 2 mg.

For elderly patients, debilitated patients and patients with organic brain lesions, liver and kidney dysfunction, pulmonary insufficiency, chronic obstructive pulmonary disease, the single dose is 0.5 – 1 mg.

The duration of treatment is set individually depending on the patient’s condition and the course of the disease. The course of treatment for abnormal insomnia – 3 – 5 days, for transient insomnia – 14 – 30 days. The maximum duration of treatment is 30 days.
Overdose
With an overdose of the drug may experience a feeling of daytime drowsiness, lethargy, dizziness, nausea, mild ataxia, allergic reactions.

Treatment: stop taking the drug, rinse the stomach. If necessary, use cardiovascular drugs and CNS stimulants, flumazenil (in the hospital). Hemodialysis is ineffective. Symptomatic therapy.
Side effects
The expressed side effects at use of drug in the recommended therapeutic doses are not revealed. However, the following side effects that may occur with the use of hypnotics and sedatives should be considered: hypersedation, muscle relaxation, mild cognitive impairment and psychomotor skills, allergic reactions, increased intraocular pressure. In the morning, in the first days of taking the drug, you may experience a feeling of drowsiness, which usually passes after 2-3 days of treatment. The frequency and severity of side effects are dose-dependent. In the event of severe adverse reactions, the dose should be reduced or the drug should be discontinued.
Special conditions
During treatment it is necessary to refuse the use of alcohol, reception of antihistamines of the first generation, tranquilizers. With caution the dosage regimen of the drug should be established for elderly patients.

The ability to influence the reaction rate when driving or operating other mechanisms.

The drug should not be taken by persons whose activities require a quick mental and motor reaction.

Application during pregnancy or lactation. Do not use.

Children

Do not use.
Special storage conditions
Shelf life. 3 years.