Indications

Broze is indicated for:

• Emotional disturbances: Acute tension and anxiety, difficulties in interpersonal contact, agitation, insomnia, and anxious depressive reactions.
• Functional disturbances:
  • Cardiovascular and respiratory: Pseudoangina pectoris, tachycardia, emotiogenic hypertension, and hyperventilation.
  • Gastrointestinal: Irritable bowel syndrome, epigastric pain, spasm, bloating, and diarrhea.
  • Urinary tract: Frequency, irritable bladder, and dysmenorrhea.
• Psychosomatic disorders: Psychogenic headache, asthma, and gastric or duodenal ulcers. It is also indicated for emotional reactions to chronic organic diseases.

Pharmacology

Bromazepam is a potent psychotropic agent. It works by binding to the GABAA​ receptor, which produces a conformational change and potentiates the receptor's inhibitory effects. At lower doses, it reduces tension and anxiety, while at higher doses, it has sedative and muscle-relaxant properties. It does not influence other neurotransmitters.

Dosage

• Standard dosage (outpatients): 1.5-3 mg up to three times daily. Treatment should start with low doses and be gradually increased.
• Severe cases (in hospital): 6-12 mg 2 or 3 times daily.
• Duration: The overall treatment should generally not exceed 8-12 weeks.
• Elderly and debilitated patients: Lower doses are required.
• Children: Bromazepam is not usually indicated. If a physician deems it appropriate, the dose should be adjusted to their low body weight (about 0.1-0.3 mg/kg).

Administration

Broze tablets are for oral administration.

Interaction

• Other centrally active drugs: Combining Broze with other CNS depressants (e.g., antidepressants, hypnotics, narcotics, antipsychotics, antiepileptics) may enhance its sedative effects.
• Cimetidine: Co-administration may prolong the elimination half-life of Broze.
• Alcohol: Concurrent intake of alcohol should be avoided as it can intensify the sedative effect of Broze.

Contraindications

Broze is contraindicated in patients with:

• Known hypersensitivity to bromazepam.
• Severe respiratory insufficiency.
• Severe hepatic insufficiency.
• Sleep apnea syndrome.

Side Effects

Common side effects include fatigue, drowsiness, muscle weakness, confusion, headache, and ataxia. These are most common at the start of therapy and usually disappear with continued use. Anterograde amnesia may occur, even at therapeutic doses.

Pregnancy & Lactation

The safety of bromazepam during pregnancy has not been established. As it is excreted in breast milk, its use should be avoided during lactation.

Precautions & Warnings

• Dependence: The use of benzodiazepines can lead to physical and psychological dependence, especially with higher doses or longer treatment durations, and in patients with a history of alcohol abuse.
• Withdrawal: Abrupt discontinuation can lead to withdrawal symptoms such as headache, muscle pain, extreme anxiety, and irritability. The dosage should be decreased gradually.
• Psychosis: Broze is not recommended as a primary treatment for sleeplessness caused by psychotic illness.
• Driving and machinery: Caution should be exercised while driving cars or using machinery.

Therapeutic Class

Broze is a benzodiazepine sedative.

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.