Description

Levana Composition
active substance: levan;

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

excipients: lactose, potato starch, calcium stearate, gelatin, violet dyes [ponso 4R (E 124), indigo (E 132)] – for a dosage of 1 mg).

Levana Dosage form
Pills.

Basic physical and chemical properties: tablets of pale violet (dosage of 1 mg) color, flat-cylindrical shape with a bevel on one surface of the tablet, the trademark of the enterprise is applied, on the second surface of the tablet – risk.

Levana Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C D.

Levana Pharmacodynamics
The drug is a partial (incomplete) selective agonist of the GABA A receptor complex. Belongs to the benzodiazepine group. It has a pronounced hypnotic, anxiolytic, moderate muscle relaxant and anticonvulsant effect; enhances the effect of sleeping pills, narcotic and neuroleptic drugs, ethyl alcohol. A feature 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, makes the hypnotic effect of the drug more physiological.

Pharmacokinetics
The drug is rapidly absorbed in the gastrointestinal tract, the bioavailability is about 80%, the half-life is 10-14 hours (the drug can be classified as a medium-acting drug). It is excreted by the renal and biliary pathways in the form of an active metabolite – 3-hydroxypochidine.

Indications
Sleep disorders of various etiologies in adults.

Contraindications
Hypersensitivity to the components of the drug. Severe chronic respiratory failure sleep apnea syndrome; severe hepatic failure; spinal and cerebellar ataxia; acute alcohol poisoning, sleeping pills, analgesics or psychotropic drugs (antidepressants, antipsychotics, lithium); severe myasthenia gravis; acute attacks of glaucoma (narrow-angle glaucoma).

Interaction with other medicinal products and other types of interactions
When using the drug, alcohol should not be consumed due to the possibility of psychomotor inhibition and respiratory depression. Do not combine the drug intake with phenothiazine neuroleptics through potentiation of the depressing effect on respiration. It should be borne in mind that cimetidine is able to increase the concentration of benzodiazepines (with the exception of 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.

Application features
During treatment, you should stop drinking alcohol, taking antihistamines of the first generation, tranquilizers. Use the drug with caution in patients with a history of alcohol, drug or drug addiction, in elderly patients.

The medicinal product contains dyes and may cause allergic reactions.

Due to the lactose content, the drug should not be taken in patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Drug treatment should be started with the lowest effective dose. The medicinal product should be taken 1 time per day in the evening before bedtime (see section “Dosage and Administration”). Violation of the dosage regimen of the drug increases the risk of adverse reactions.

The ability to influence the reaction rate when driving or operating machinery
The drug should not be taken by patients whose activities require a quick mental and motor response.

Use during pregnancy or lactation
Do not use.

Method of administration and dosage
Used internally. Swallow 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 is achieved). The maximum single and daily dose is 2 mg.

For elderly patients, debilitated patients and patients with organic brain lesions, impaired liver and kidney function, pulmonary insufficiency, chronic obstructive pulmonary disease, a single dose is 0.5-1 mg.

The duration of treatment is determined by the doctor individually, depending on the patient’s condition and the course of the disease. The course of treatment for abnormal insomnia is 3-5 days, for transient insomnia – 14-30 days. The maximum duration of the course of treatment is 30 days.

Children
Do not use.