Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 2022-03-13
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Symptomatic treatment of functional disorders or somatic manifestations associated with a pathological state of fear or mental stress, insomnia.
Neuroses and psychopathies (accompanied by phobias, anxiety, tension), insomnia (with fear neuroses), functional psychosomatic disorders of the cardiovascular (pseudostenocardia, arterial hypertension of emotional origin), respiratory (hyperventilation, difficulty breathing, shortness of breath), gastrointestinal (irritable bowel syndrome), urogenital (frequent urination, dysmenorrhea) systems, psychogenic headache and dermatoses, relieving anxiety and fear of surgical and endoscopic manipulations.
The dosage depends on the severity and nature of the symptoms, as well as on the patient's susceptibility. At the beginning of the course of therapy, the adult dose is 6 mg per day (1.5 mg in the morning, 1.5 mg at noon and 3 mg in the evening). Gradually, the dose is adjusted depending on the therapeutic effect. The usual dose ranges from 6 to 18 mg per day (in 3 doses). In severe cases, it may be necessary to increase the dosage to 24-36 mg per day. Discontinuation of treatment should be carried out with a gradual reduction in dosage. For debilitated or elderly patients, the dosage should be reduced by half. A reduction in the dosage should also be provided in the case of hepatic, renal or respiratory failure
Inside, at night 1.5-3 mg, if necessary, increase the evening dose to 6 mg, it is possible to prescribe an additional dose-1.5-3 mg 1-2 times during the day. In the hospital — up to 12-18 mg/day for 3-4 doses (reducing the daily dose is carried out, reducing the daily intake). A long course of treatment is stopped gradually.
Hypersensitivity, severe myasthenia gravis, severe respiratory failure, childhood.
Hypersensitivity (including to benzodiazepines), drug or alcohol dependence, myasthenia gravis.
Drowsiness (especially in elderly patients), muscle hypotension, dizziness, ataxia, paradoxical reactions (irritability, aggressiveness, confusion, agitation), headaches, amnesia, gastrointestinal disorders, agranulocytosis, skin rash. In case of abrupt discontinuation of treatment: exacerbation of anxiety, insomnia, irritability, tremor, muscle pain, nausea, vomiting, headache, convulsions, epileptic crises, inability to concentrate, feeling of depersonalization.
Headache, dizziness, fatigue, drowsiness, impaired concentration, slow mental and motor reactions, memory loss, ataxia, muscle weakness, increased appetite, decreased libido, rarely-agitation, aggression, fear, sleep disorders, hallucinations, suicidal tendencies, dry mouth, nausea, diarrhea, impaired liver and kidney function, arterial hypotension, changes in the peripheral blood picture.
Signs of intoxication: very deep sleep, comatose state. Treatment: symptomatic.
The maximum concentration in the plasma is reached 2 hours after administration. 70% of bromazepam binds to plasma proteins. Excretion occurs in the urine, mainly in the form of glucuronides of hydroxyl metabolites: 3-hydroxybromazepam and a derivative of 3-hydroxybenzenpyridine. Both metabolites are active, but their pharmacological activity is of no clinical significance, since they are rapidly eliminated. Approximately 2% of bromazepam enters the urine unchanged. The half-elimination period of bromazepam from plasma is about 12 hours. Like all benzodiazepines, bromazepam penetrates the placental barrier and is excreted in the mother's milk.
The sedative effect is enhanced by alcohol, sleeping pills, psychotropic drugs, analgesics and muscle relaxants. Catabolism is accelerated by rifampicin, slowed by cimetidine, disulfiram, isoniazid, and oral contraceptives.