Temporary, short-term symptomatic treatment: neurotic syndromes, also with somatic background; anxiety disorders including those associated with somatic diseases (cancer, ischemic heart disease, hypertension, gastric and duodenal ulcer); sleep disorders; symptoms of excitation in the alcohol abstinence syndrome; diseases with increased muscle tone (e.g. spastic states after stroke, injuries, multiple sclerosis, discopathy, torticollis). In traumatology and motor rehabilitation to reduce skeletal muscle tone. Premedication (preparation for some surgical and diagnostic procedures). Conditions of tension and anxiety associated with everyday problems are not an indication for the use of the drug.
Composition:
1 tabl powl. contains 5 mg diazepam.
Action:
The drug belongs to the group of 1,4-benzodiazepine derivatives. It inhibits many o.u.n. structures (brain, cerebellum, limbic system, hypothalamus, spinal cord). The drug increases the affinity of the GABAergic receptor to gamma-aminobutyric acid (GABA), which is an endogenous inhibitory neurotransmitter. The product has a strong anxiolytic, calming and anticonvulsant effect. It also works hypnotically and reduces skeletal muscle tone. After oral administration, it is well absorbed from the gastrointestinal tract. Bioavailability is about 98%, the maximum concentration in the blood occurs after 0.9-1.3 hours. The blood proteins bind in 94-99%. The drug penetrates the blood barrier - the cerebrospinal fluid and through the placenta. T0,5 is about 24-48 h. The biotransformation process takes place in the liver, active metabolites (nordiazepam, temazepam, oxazepam) are formed, which are then coupled with glucuronic acid. The drug and its metabolites are mainly excreted in the urine.
Contraindications:
Hypersensitivity to 1,4-benzodiazepine derivatives or other components of the preparation. Severe respiratory failure, regardless of the cause. Sleep apnea syndrome. Severe hepatic and renal failure.Myasthenia gravis.
Precautions:
Psychological and physical addiction may develop during treatment - particularly cautiously use in patients with an addiction to alcohol, drugs or other medicines in the past. Regular use can lead to the development of tolerance. A few hours after taking the medicine (especially a large dose), you may experience amnesia. If paradoxical reactions occur (more often in elderly patients or addicted to alcohol), the use of the drug should be discontinued. Use in patients with severe hepatic impairment and in patients with psychosis is not recommended. Particularly cautiously use in elderly patients (over 65 years), in patients with symptoms of depression (suicidal risk). Caution should be exercised in patients with chronic respiratory failure, with renal insufficiency and / or liver, with porphyria, with glaucoma (especially with a narrow angle of perception). The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
The use of a drug in pregnancy is only acceptable if absolutely necessary, and the use of safer counterparts is impossible or contraindicated. If it is necessary to administer in the third trimester of pregnancy or in the perinatal period, the fetus and newborn may experience cardiac arrhythmia, impaired breathing and weakness of the sucking reflex. In children of mothers receiving benzodiazepines, symptoms of withdrawal syndrome were observed in late pregnancy. If it is necessary to administer the medicine during lactation, breast-feeding should be discontinued.
Side effects:
Most often at the beginning of treatment: drowsiness, slowing of the reaction, pain and dizziness, confusion, confusion, ataxia; less often (especially at high doses): dysarthria with speech blurred and abnormal pronunciation, memory disorders, libido disorders. Rare: nausea, stomach complaints, dry mouth.In addition, visual disturbances (blurred vision, double vision), bradycardia, chest pain, slight decrease in blood pressure, urinary retention, urinary incontinence, muscle twitching, muscle weakness, loss of appetite, menstrual disorders, general weakness, fainting, may occur. allergic skin reactions (rash, pruritus, urticaria), slight increase in aminotransferase, liver dysfunction with jaundice, disturbances in blood morphology, paradoxical reactions (psychomotor anxiety, insomnia, agitation, aggression, muscle tremor, convulsions). Psychological and physical addiction may develop during treatment. Abrupt discontinuation of treatment may cause symptoms of withdrawal syndrome: headache, muscle pain, agitation, emotional tension, restlessness, confusion, confusion, irritability, insomnia; in severe cases: loss of sense of reality, personality disorders, hypersensitivity to touch, acoustic stimuli, light, tingling and limb numbness, hallucinations, convulsions. During therapy, pre-existing undiagnosed depression may appear.
Dosage:
Orally. Dosage and duration of treatment should be determined individually. Adults. In anxiety and anxiety: 5-10 mg daily in 1-2 divided doses. Symptoms of alcohol withdrawal: up to 30 mg daily in divided doses, usually 10 mg 3 times a day; in justified cases, especially in alcohol psychoses, the dose can be increased to 60 mg daily (the need to check for possible respiratory disorders). In insomnia: 5-10 mg 30 minutes before bedtime. In spastic muscles: 5-15 mg daily in divided doses, in severe cases, the dose can be increased to 60 mg per day. Elderly patients should not exceed half of the recommended dose in adult patients. A dose reduction may be necessary in patients with renal and / or renal failure. The duration of treatment should be kept to a minimum. The duration of treatment, including the period of gradual dose reduction, should not exceed 4 weeks. In individual cases, this period may be prolonged, but the decision should be taken after a thorough assessment of the patient's condition. The drug should be taken with a small amount of water.
(C)
