Brand Name: Bromalex

Generic Name: Bromazepam

Active Ingredient(s): Bromazepam (3 mg)

For the General Public:

Uses:

Bromalex 3 mg is used for:

• Management of anxiety disorders.
• Short-term relief of symptoms of anxiety.
• Treatment of anxiety-related insomnia.

How It Works:

Bromalex contains bromazepam, a benzodiazepine that enhances the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that calms brain activity, reducing anxiety and inducing relaxation.

Dosage:

• Typically 1.5–3 mg taken up to three times daily or as directed by a healthcare provider.

Possible Side Effects:

• Common Side Effects: Drowsiness, dizziness, lightheadedness, dry mouth, and fatigue.
• Serious Side Effects: Severe confusion, difficulty breathing, unusual behavior changes, or extreme drowsiness. Contact a doctor immediately if you experience these.

Important Information:

• Dosage Instruction: Follow your doctor’s recommendations. Avoid exceeding the prescribed dose.
• Usage Instruction:
  • Can be taken with or without food.
  • Avoid alcohol during treatment.
• General Information:
  • Not suitable for prolonged use due to dependency risks.
  • Consult your doctor before use if pregnant, breastfeeding, or planning pregnancy.
  • Keep out of reach of children.

Drug Interactions:

• With Other Medications:
  • May interact with other central nervous system depressants like alcohol, opioids, and sedatives.
  • Avoid combining with certain antidepressants, antipsychotics, or anticonvulsants.
• With Food:
  • Avoid grapefruit juice, which can increase bromazepam levels in the bloodstream.

Regulatory Approval & Manufacturer:

• Approved by [Regulatory Authority] and manufactured by [Manufacturer].

Antidotes (If Overdose or Misuse):

• Flumazenil can be used as an antidote under medical supervision.
• Supportive care, including airway management, is essential in cases of overdose.

For Pharmacists:

Medicine Name: Bromalex

Brand: Bromalex
Active Ingredient(s): Bromazepam

Indications:

• Management of anxiety and related disorders.
• Short-term treatment of insomnia associated with anxiety.

Pharmacodynamics:

• Mechanism of Action:
  Bromazepam binds to benzodiazepine receptors in the central nervous system, enhancing the effect of GABA, leading to a calming and anxiolytic effect.
• Pharmacological Effects:
  • Reduces anxiety symptoms.
  • Promotes relaxation and induces sleep.
• Receptor Binding:
  Binds with high affinity to GABA-A receptor benzodiazepine sites, potentiating inhibitory neurotransmission.

Pharmacokinetics:

• Absorption: Rapidly absorbed, with peak plasma levels achieved within 1–2 hours.
• Distribution: Extensively distributed; ~70% bound to plasma proteins.
• Metabolism: Metabolized in the liver to active and inactive metabolites.
• Elimination: Excreted via urine, primarily as metabolites.
• Half-Life: Approximately 20 hours.

Dosage and Administration:

• Adults: 1.5–3 mg two to three times daily.
• Special Populations:
  • Renal Impairment: Monitor for side effects; dose adjustment may be necessary.
  • Hepatic Impairment: Use cautiously; monitor liver function and adjust dose as required.

Contraindications:

• Hypersensitivity to bromazepam or benzodiazepines.
• Severe respiratory or hepatic impairment.
• Myasthenia gravis.
• Sleep apnea syndrome.

Warnings and Precautions:

• Prolonged use increases the risk of dependence and withdrawal symptoms.
• Use cautiously in elderly patients and those with a history of substance abuse.
• Taper off gradually; avoid abrupt discontinuation to prevent withdrawal effects.

Drug-Drug Interactions:

• CNS Depressants: Enhanced sedation with alcohol, opioids, or other sedatives.
• Enzyme Inhibitors/Inducers:
  • CYP3A4 inhibitors (e.g., ketoconazole) increase bromazepam levels.
  • CYP3A4 inducers (e.g., rifampin) may reduce efficacy.

Drug-Food Interactions:

• Grapefruit juice can inhibit bromazepam metabolism, increasing plasma concentrations and risk of side effects.

Adverse Reactions:

• Common: Sedation, dizziness, dry mouth, and lightheadedness.
• Serious: Respiratory depression, severe confusion, and allergic reactions.

Therapeutic Effects:

• Effective management of anxiety symptoms.
• Improvement in sleep quality in anxiety-related insomnia.

Storage:

• Store at 20–25°C, away from light and moisture.

Packaging:

• Available in blister packs containing 3×10 tablets (30 tablets).

Clinical Considerations:

• Pregnancy Category: D (Avoid unless absolutely necessary).
• Lactation: Avoid use during breastfeeding; may be excreted in breast milk.
• Pediatric Use: Not recommended for children under 18 years without specialist advice.
• Geriatric Use: Start with lower doses to reduce sedation and fall risk.

Conclusion:

Bromalex 3 mg is a benzodiazepine indicated for managing anxiety and related conditions. Its proper use ensures effective symptom relief while minimizing risks. Consult a healthcare provider for personalized advice and adhere to prescribed dosages for safe use