Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties. In low dosage, it diminishes anxiety, tension and nervousness. In high dosage, the sedative and muscle-relaxant properties appear.
Pharmacology: Bromazepam is a benzodiazepine with anxiolytic and sedative properties, which are of value in the symptomatic relief of pathological anxiety in psychoneurotic patients. The absolute bioavailability of unchanged, orally administered bromazepam is 60%, and peak blood levels are achieved within 2 hours after administration. On average, 70% of bromazepam is bound to plasma proteins. Bromazepam is metabolized in the liver, and has an elimination half-life of 20 hours (the half-life may be longer in elderly patients). The metabolites are excreted in the urine as conjugated form. Bromazepam binds to specific site on the GABA, an important inhibitory neurotransmitters in the CNS, which acts by opening chloride ion channel into the cells.
[Educational purpose only, do not take medicine without prescription from registered physician]
Indications: Bromazepam is indicated in the following diseases:
* Emotional disturbances: Anxiety and tension states, as adjuvant therapy for anxiety in depressed patients, nervous tension, restlessness, and anxiety- and tension- related insomnia. As an adjuvant to treatment of underlying disease responsible for functional or psychosomatic impairments of various organs caused by anxiety and tension.
* Cardiovascular and respiratory systems: Pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea, and hyperventilation.
* Gastrointestinal tract: Irritable bowel syndrome, ulcerative colitis, epigastric pain, spasm, meteorism, and diarrhoea.
* Urogenital tract: Irritable bladder, urinary frequency and dysmenorrhea.
* Other psychosomatic disturbances: Psychogenic headache, psychogenic dermatoses.
Dosage & Administration:
Adults: The optimum dosage and frequency of administration of Bromazepam is based on the individual patient, the severity of symptoms and previous psychotropic drug history.
Average dose for outpatient therapy: 1.5 – 3 mg 3 times daily.
Severe cases, especially in hospitals: 6 – 12 mg 2 – 3 times daily.
Treatment of outpatients should begin with low doses, gradually increasing to the optimum level. In general, the total duration of treatment should not exceed 8-12 weeks including a tapering-off period. In certain cases, treatment may need to be continued beyond the maximum recommended duration but only after a careful reassessment of the patient’s condition and indications.
Elderly patients: Doses should not exceed half those normally recommended.
Children: Bromazepam is not for paediatric use.
Contraindications: In patients with known hypersensitivity to benzodiazepines, myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, or sleep apnoea syndrome.
Warning & Precautions: In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced.
Bromazepam should not be used alone to treat depression or anxiety associated with depression.
Bromazepam should be used with extreme caution in patients with a history of alcohol or drug abuse.
Side Effects: Common side effects include drowsiness, sedation, unsteadiness and ataxia. These are dose-related and may persist into the following day, even after a single dose. Other side effects are rare and include headache, vertigo, hypotension, gastrointestinal upsets, skin rashes, visual disturbances and urinary retention.
Drug Interaction: Bromazepam may potentiate or interact with the effects of other CNS acting drugs such as alcohol, narcotics, hypnotics, sedative antihistamines, antipsychotics, anxiolytics/sedatives, anesthetics, antidepressants and anticonvulsants. Therefore, if bromazepam is to be combined with other drugs acting on the CNS, careful consideration should be given to the pharmacology of the agent involved because of possible additive or potentiation of drug effects.
Use in Pregnancy & Lactation:
Pregnancy: The safety of Bromazepam in pregnant women has not been established. Bromazepam should not be used during pregnancy, especially during the first and last trimesters, unless there are compelling reasons.
Lactation: Benzodiazepines have been detected in breast milk. If possible, the use of Bromazepam should be avoided during lactation.
Overdose: Manifestations of overdosage include somnolence, confusion, and respiratory and cardiovascular depression with coma in severe cases.
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