Bromazepam

Bromazepam is a potent psychotropic agent belonging to the benzodiazepine class. At lower doses, it selectively reduces tension and anxiety; at higher doses, it exhibits sedative and muscle-relaxant properties.

Bromazepam binds to the GABA-A receptor, producing a conformational change and potentiating its inhibitory effects. It is indicated for emotional disturbances (acute tension and anxiety states), difficulties in interpersonal contact, agitation, insomnia, anxious and depressive reactions, functional disturbances in the cardiovascular and respiratory systems (pseudoangina, tachycardia, dyspnea), gastrointestinal disturbances (irritable bowel syndrome, epigastric pain), urinary tract disturbances (frequency, irritable bladder, dysmenorrhea), and psychosomatic disorders (psychogenic headache, asthma, gastric and duodenal ulcer).

• Emotional disturbances (acute tension and anxiety states)
• Difficulties in interpersonal contact
• Agitation, insomnia, anxious and depressive reactions
• Functional disturbances in cardiovascular and respiratory systems (pseudoangina, tachycardia, dyspnea)
• Gastrointestinal disturbances (irritable bowel syndrome, epigastric pain, spasm)
• Urinary tract disturbances (frequency, irritable bladder, dysmenorrhea)
• Psychosomatic disorders (psychogenic headache, asthma, gastric and duodenal ulcer)
• Emotional reactions to chronic organic disease

Adults (Outpatients): 1.5-3 mg up to three times daily (start with low doses and gradually increase).

Severe cases (especially in hospital): 6-12 mg 2-3 times daily.

Maximum treatment duration: Generally not more than 8-12 weeks; may be extended with re-evaluation by a specialist.

Elderly and debilitated patients: Lower doses required.

Hepatic impairment: Reduce dose by at least half.

Children: Generally not indicated; if necessary, dose should be based on body weight (0.1-0.3 mg/kg).

Renal impairment: No dosage adjustment needed.

Common side effects: Drowsiness, sedation, muscle weakness, ataxia, fatigue, headache, confusion, depression, slurred speech, changes in libido, tremor, visual disturbances, urinary retention, GI disturbances, changes in salivation, amnesia (anterograde amnesia).

Rare: Jaundice, blood disorders, hypersensitivity reactions, pain and thrombophlebitis (with injection), raised liver enzyme values, paradoxical excitation.

Side effects predominantly occur at the start of therapy and usually disappear with prolonged administration.

• Physical and psychological dependence may develop (dose and duration dependent; higher risk in patients with alcohol history).
• Do not stop abruptly (withdrawal symptoms: headache, muscle pain, extreme anxiety, tension, confusion, irritability; taper dose gradually).
• Drowsiness may affect alertness; exercise caution when driving or operating machinery.
• Caution in chronic pulmonary insufficiency, muscle weakness, impaired liver or kidney function, personality disorders, organic brain changes, history of alcohol or drug addiction.
• Parenteral administration may cause respiratory depression and hypotension; use only when facilities for reversing respiratory depression are available.
• Do not use during pregnancy and lactation.

• Pre-existing CNS depression or coma
• Respiratory depression
• Acute pulmonary insufficiency or sleep apnea
• Severe hepatic impairment
• Chronic psychosis, phobic or obsessional states
• Not used alone to treat depression or anxiety associated with depression (may precipitate suicide or aggressive behavior)
• Glaucoma
• Hypersensitivity to bromazepam

• CYP450 inhibitors (azole antifungals, macrolides, HIV protease inhibitors, calcium channel blockers): May enhance bromazepam activity.
• Disulfiram or cimetidine: Elevated plasma levels.
• Barbiturates, sedatives, anesthetics, anxiolytics, hypnotics, phenothiazines, other antipsychotics, skeletal muscle relaxants: Additive CNS depressant effects.
• Atropine, antihistamines, antidepressants: May potentiate anticholinergic effects.
• Narcotic analgesics: Increased psychic drug dependence.
• Alcohol: Enhanced sedative effects; avoid alcohol consumption.