Bromalex 6 mg

Indication

Bromalex is a benzodiazepine anxiolytic indicated for the short-term symptomatic relief of severe anxiety, tension, agitation and emotional disturbance that is disabling or subjecting the individual to unacceptable distress. Also used as an adjunct in the management of anxiety associated with psychosomatic, functional or organic illness. Treatment of anxiety should only be initiated after non-pharmacological approaches have been considered.

Ingredients

• Bromazepam 6 mg

Direction

Oral route. Adults: usual outpatient dose is 1.5 to 3 mg two or three times daily, adjusted according to response; severe cases may require 6 to 12 mg two or three times daily under medical supervision. Elderly or debilitated patients: start with half the usual adult dose. Treatment should be as short as possible (generally not more than 8 to 12 weeks including gradual tapering) and reviewed regularly. Do not discontinue abruptly after prolonged use; taper the dose gradually.

Side effects

• Drowsiness
• sedation
• fatigue
• muscle weakness
• Ataxia
• dizziness
• headache
• Confusion and memory impairment (anterograde amnesia)
• Paradoxical reactions: agitation
• irritability
• aggressiveness
• hallucinations (especially in children and elderly)
• Dependence and withdrawal symptoms on prolonged use or abrupt discontinuation
• Respiratory depression
• particularly at high doses or when combined with other CNS depressants
• Rarely
• hypotension
• rash
• gastrointestinal disturbances

Precautions

• Contraindicated in myasthenia gravis
• severe respiratory insufficiency
• sleep apnoea syndrome
• severe hepatic insufficiency and in patients with hypersensitivity to benzodiazepines
• Avoid use in pregnancy (especially first trimester and near delivery) and breastfeeding
• Risk of dependence increases with dose and duration
• keep treatment as short as possible
• Do not consume alcohol or other CNS depressants during treatment
• Impairs driving and use of machinery
• do not drive or operate machinery while affected
• Use with caution in elderly
• in hepatic or renal impairment
• and in patients with history of drug or alcohol abuse
• Taper the dose gradually to avoid withdrawal (anxiety rebound
• insomnia
• tremor
• seizures)
• Store in a secure place out of reach of children
• schedule controlled substance
• Keep out of reach of children