Notens

Bromazepam BP

Description:

Bromazepam is a benzodiazepine with anxiolytic and sedative properties, which are of value in the symptomatic relief of pathological anxiety in psychoneurotic patients.

Composition:

Each tablet contains bromazepam BP 3 mg.

Pharmacology:

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 receptor /chloride channel complex and potentiates the effect of GABA, an important inhibitory neurotransmitters in the CNS, which acts by opening chloride ion channel into the cells.

Indication:

Emotional disturbances: Acute tension and anxiety states, difficulties in interpersonal contacts, agitation, insomnia, anxious and agitated depressive reaction.

Functional disturbances in the cardiovascular and respiratory system: Pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnoea, and hyperventilation.

In the gastrointestinal system: Irritable bowel syndrome, epigastric pain, spasm, bloating, diarrhoea. In the genitourinary system: Frequency, irritable bladder and dysmenorrhoea.

Other psychosomatic disorders: Psychogenic headache, psychogenic dermatoses, asthma, gastric and duodenal ulcer, and ulcerative colitis.

Emotional reactions to chronic organic disease. Adjuvant to psychotherapy in psychoneurosis.

Dosage and administration:

Usual dose for anxiety is 3 to 18 mg daily in divided dose. Higher doses up to 60 mg have occasionally been given to hospitalized patients. Dose should be reduced at least half in elderly patients and those with hepatic and renal impairment.

Contraindication:

In patients with known hypersensitivity to benzodiazepines, myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, or sleep apnoea syndrome.

Side effects:

Drowsiness and lightheadedness the next day; confusion and ataxia (specially in the elderly); amnesia may occur; dependence; paradoxical increase in aggression; occasionally headache, vertigo, hypotension, salivation changes, gastrointestinal disturbances, visual disturbances, dysarthria, tremor, changes in libido, incontinence, urinary retention, blood disorders and jaundice reported.

Precautions:

Bromazepam is not recommended for use in patients with depressive disorders or psychosis. Patients should be advised against the concurrent use of alcohol and other CNS depressant drugs. Patients with known or presumed dependence from alcohol or drugs should not take benzodiazepines.

Since bromazepam has a CNS depressant effect, patients should be warned against driving, operating dangerous machinery, or engaging in other hazardous activities requiring mental alertness and physical coordination.

High Risk Group:

Pregnancy: The safety of using bromazepam in pregnancy has not been established. Therefore, bromazepam should not be used during pregnancy.

Lactation: Bromazepam and its metabolites are probably excreted in human milk. Therefore, this drug should not be given to nursing mothers.

Children: Because of the lack of sufficient clinical experience, bromazepam is not recommended for use in patients less than 18 years of age.

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.

Overdose

Symptoms: Overdosage manifestations include drowsiness, somnolence, ataxia, impaired vision, depressed reflexes and finally coma. Hypotension, hypotonia and respiratory depression and very rarely death may occur with large overdoses.

Treatment: Vital signs should be monitored and general supportive measures should be employed as indicated. Special attention should be paid to respiratory and cardiac function in intensive care. Flumazenil may be useful as an antagonist.

Storage:

Protect from light. Store at 15º to 30º C. Keep out of the reach of children.

Packing:

Each box contains 5x10's tablets in blister pack.