Bromazep Tablet: Each tablet contains Bromazepam BP 3 mg.
Anxiolytic & Antidepressant.
It is indicated for the short term use in anxiety & anxiety associated physiological problems.
It is contraindicated in respiratory depression, acute pulmonary insufficiency, sleep apnoea syndrome, severe hepatic impairment, myesthenia gravis. It is not for chronic psychosis. It should not be used alone in depression or in anxiety with depression. It should be used cautiously in patients with history of drug or alcohol abuse.
Dosage & Administration
The usual adult dose is 1.5-3 mg up to three times daily. In elderly or debiliated patients the dose is half the adult dose. The maximum dose is 60 mg daily in divided doses (in exceptional circumstances in hospitalized patients).
Drowsiness, lightheadedness the next day , confusion and ataxia (especially in the elderly), amnesia, dependence and paradoxical increase in aggression, muscle weakness may occur. Occasionally headache, vertigo, hypotension, salivation changes, gastrointestinal disturbances, visual disturbances, tremor, changes in libido, incontinence, urinary retention, blood disorders, jaundice, skin reactions are reported.
Benzodiazepines may induce anterograde amnesia. Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behavior and other adverse behavioral effects are known to occur when using benzodiazepines. The concomitant use of bromazepam with alcohol or/and CNS depressants should be avoided. Some loss of efficacy to the effects of benzodiazepines may develop after repeated use for a few weeks. Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Elderly should be given a reduced dose A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy. Benzodiazepines are not recommended for the primary treatment of psychotic illness. Benzodiazepines should not be used alone to treat depression or anxiety associated with depression. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
The safety of Bromazepam in pregnant woman has not been established. Since Benzodiazepines are excreted in breast milk , nursing mothers should not take Bromazepam.
Phenothiazines, barbiturates, MAO inhibitors, and psychoactive drugs may potentiate the action of Bromazepam and should not be given concurrently. Simultaneous intake of alcohol should be avoided.