the product in the database has an inactive status
indications:
Supportive treatment of muscle contractures in rheumatology.
Composition:
1 tabl powl. contains 50 mg of tetrazepam. The drug contains lactose.
Action:
Benzodiazepine derivative with a strong skeletal muscle relaxant effect. It also works calming, anxiolytic, hypnotic and anticonvulsant; reduces tension, relieves pain. After oral administration, tetrazepam is absorbed quickly and almost completely from the gastrointestinal tract. The food does not affect the kinetics of the preparation. The beginning of action occurs after about 14 minutes. It is strongly bound to plasma proteins. Tetrazepam is metabolised in the liver. It is excreted in urine (70%) and faeces (30%) mainly in the form of a combination of hydroxyl-3'-tetrazepam with glucuronic acid. T0,5 is 22 ± 4 h and is prolonged in the elderly and in people with renal and hepatic impairment. Tetrazepam passes through the placenta barrier and into breast milk.
Contraindications:
Hypersensitivity to tetrazepam or other benzodiazepine derivatives or other components of the preparation. Severe respiratory failure. Sleep apnea syndrome. Severe hepatic failure (risk of encephalopathy). Myasthenia gravis. Children under 6 years old. Alcohol consumption. Breast-feeding.
Precautions:
In children> 6 years of age, the drug should only be used in cases where treatment is absolutely necessary (the risk of a severe spastic syndrome). During long-term treatment with tetrazepam, the development of tolerance to the drug and physical and psychological dependence may occur. Tetrazepam should be used over the shortest possible period to reduce the risk of addiction. Exercise caution in the treatment of patients with a history of addiction to other drugs, agents or alcohol due to their greater susceptibility to drug addiction. Benzodiazepine derivatives may cause secondary amnesia within a few hours of using the drug. In patients with respiratory failure, tetrazepam should be used only in special cases and under strict control; use of the drug in patients with severe respiratory failure is contraindicated. Caution should be exercised in elderly patients and patients with renal or hepatic impairment; lower doses should be used in these patient groups. The drug contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
Tetrazepam is not recommended during the first trimester of pregnancy. In the second trimester of pregnancy, the drug can only be used in cases of necessity in the third trimester - high doses should be avoided. The use of high doses of benzodiazepines in the third trimester of pregnancy may cause hypotension, respiratory distress, low body temperature, reduced muscle tone in the newborn, weakness of the sucking reflex. In the newborn, withdrawal symptoms may occur. Do not use the drug while breastfeeding. The use of benzodiazepine derivatives by breastfeeding women may result in the reduction of muscle tone and excessive sedation, including lethargy.
Side effects:
During treatment, you may experience: tiredness, weakness, decreased muscle tone, decreased concentration, speech disorders - most often in the elderly, usually at the beginning of treatment and when using high doses of the drug; post-amnesia and paradoxical reactions (irritability, aggressiveness, agitation, behavioral disorders, disturbances of consciousness) especially in the elderly and children; psychophysical addiction with withdrawal syndrome or "rebound" response after discontinuation of treatment; reduction of libido; allergic reactions (erythema, skin rash, pruritus, urticaria, angioneurotic edema); nausea, vomiting, diarrhea, constipation. Reductions in the number of leukocytes and lymphocytes have been rarely observed. Very rare: Stevens-Johnson syndrome and toxic epidermal necrolysis.Sudden discontinuation of the benzodiazepine derivative causes withdrawal symptoms (most often insomnia, headache, increased anxiety, increased tension and muscle aches, excessive excitability).
Dosage:
Orally. Adults.Patients treated out-patient: initially 50 mg in the evening before bed; if necessary, the dose may be gradually increased, by 25 mg daily, to the optimal dose, not higher than 100 mg daily (this dose may be used once at bedtime or divided into 2-3 doses, the highest dose should be taken in the evening).Patients hospitalized or bedridden patients: initially 50 mg in the evening before bed; if necessary, the dose can be gradually increased, by 25 mg daily, to the optimal dose, however not higher than 150 mg daily (this dose can be used once at bedtime or divided into 2-3 doses, the highest dose should be taken in the evening). Children> 6 years: use the medicine only when treatment is absolutely necessary, the maximum dose of 4 mg / kg / day in divided doses. Elderly patients and patients with renal or hepatic impairment are advised to use lower doses of the preparation.
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