Instructions for Levana IC tablets 0.001 g No. 10
Composition
active ingredient: levana;
1 tablet contains levani (mono-[7-bromo-2-oxo-5-(2-chlorophenyl)-2,3-dihydro-1H-benzo[1,4]diazepin-3-yl]succinate monohydrate) 0.5 mg, 1 mg or 2 mg;
excipients: lactose monohydrate, potato starch, calcium stearate, gelatin, dyes (sunflower yellow FCF (E 110) - for a dosage of 0.5 mg; violet [ponso 4R (E 124), indigo carmine (E 132)] - for a dosage of 1 mg).
Dosage form
Pills.
Main physicochemical properties: pale orange (dosage 0.5 mg), pale purple (dosage 1 mg) and white (dosage 2 mg) tablets, flat-cylindrical with a bevel; one surface of the tablet has the company's trademark, the other surface of the tablet has a line.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C D.
Pharmacological properties
Pharmacodynamics
The drug is a partial (incomplete) selective agonist of the GABA A-receptor complex. It belongs to the group of benzodiazepine derivatives. It has a pronounced hypnotic, anxiolytic, moderate muscle relaxant and anticonvulsant effect; enhances the effect of hypnotic, 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 its 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%, half-life is 10-14 hours (the drug can be classified as a medium-acting agent). It is excreted by the renal and biliary routes in the form of an active metabolite - a 3-hydroxy derivative.
Indication
Sleep disorders of various etiologies in adults.
Contraindication
Increased individual sensitivity to any of the components of the drug. Severe chronic respiratory failure; sleep apnea syndrome; severe liver failure; spinal and cerebellar ataxia; acute poisoning with alcohol, hypnotics, analgesics or psychotropic drugs (antidepressants, neuroleptics, lithium); severe myasthenia gravis; acute attacks of glaucoma (narrow-angle glaucoma).
Interaction with other medicinal products and other types of interactions
During the use of the drug, alcohol should not be consumed due to the possibility of psychomotor retardation and respiratory depression. The drug should not be combined with phenothiazine neuroleptics due to potentiation of respiratory depression. It should be borne in mind that cimetidine is able to 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 drinks, may reduce the therapeutic effect of the drug.
Application features
During treatment, you should refrain from drinking alcohol, taking first-generation antihistamines, and tranquilizers. The drug should be used with caution in patients with a history of alcohol, drug, or drug addiction, and in elderly patients.
The medicine contains dyes, which may cause allergic reactions.
Due to the lactose content, the medicinal product should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Treatment with the drug should be started with the lowest effective dose. The drug should be taken once a day in the evening before bedtime (see the section "Method of administration and dosage"). Violation of the dosage regimen of the drug increases the risk of developing adverse reactions.
Use during pregnancy or breastfeeding
Not used.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should not be taken by patients whose activities require rapid mental and motor reactions.
Method of administration and doses
It is used internally. Swallow without chewing. The medicine should be taken once 30-60 minutes before bedtime.
A single dose is 0.5-2 mg (set individually, starting with the lowest 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
Not used.
Overdose
In case of an overdose of the drug, daytime drowsiness, hypersedation, lethargy, general weakness, impaired cognitive functions, decreased concentration, dizziness, nausea, ataxia, weakness in the limbs, and allergic reactions are possible.
Treatment: stop taking the drug, wash the stomach. If necessary, use cardiovascular drugs and central nervous system stimulants, flumazenil (in hospital conditions). Hemodialysis is ineffective. Symptomatic therapy.
Side effects
The drug is usually well tolerated when used in recommended therapeutic doses. Isolated cases of adverse reactions have been reported.
Nervous system: headache, ataxia, weakness in the limbs, hypersedation, daytime drowsiness.
In the first days of taking the drug, you may feel drowsy in the morning, which usually disappears after 2-3 days of treatment.
Mental disorders: impaired cognitive functions, decreased concentration.
Respiratory system: difficulty breathing.
Skin and mucous membranes: angioedema, itching, rash.
General disorders: lethargy, general weakness.
When using the drug, one should take into account adverse reactions that may develop when using other hypnotics and sedatives: muscle relaxation, impaired psychomotor skills, increased intraocular pressure, allergic reactions.
The frequency and severity of adverse reactions are dose-dependent. If severe adverse reactions occur, the dose should be reduced or the drug should be discontinued.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 2 blisters (for 0.5 mg dosage) and 1 blister (for 1 mg and 2 mg dosage) in a pack.
Vacation category
According to the recipe.
Producer
Additional Liability Company "INTERCHEM".
Address
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
