Bromazep
Generic Name
Bromazepam
Manufacturer
Various manufacturers (e.g., Square Pharmaceuticals Ltd. in Bangladesh)
Country
Global, Bangladesh (for local brands)
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
bromazep 3 mg tablet | ৳ 5.50 | ৳ 55.00 |
Description
Overview of the medicine
Bromazepam is a benzodiazepine derivative primarily used for its anxiolytic properties. It is prescribed for the short-term treatment of anxiety, panic disorders, and sometimes for insomnia related to anxiety. It acts by enhancing the effect of gamma-aminobutyric acid (GABA) in the brain.
Uses & Indications
Dosage
Adults
Typical dose for outpatients: 1.5-3 mg, two to three times daily. For hospitalized patients with severe anxiety: 6-12 mg, two to three times daily. Maximum daily dose should not exceed 18-30 mg depending on severity.
Elderly
Elderly patients and those with debilitating conditions should start with a lower dose (e.g., 1.5 mg once or twice daily) and be carefully monitored due to increased sensitivity and potential for adverse effects.
Renal_impairment
Dose adjustment may be necessary in patients with severe renal impairment. Start with lower doses and monitor closely.
How to Take
Bromazepam tablets should be swallowed whole with water, with or without food. Do not chew or crush the tablet.
Mechanism of Action
Bromazepam binds to specific benzodiazepine receptors on the GABAA receptor complex in the central nervous system. This binding enhances the affinity of GABA for its receptor, leading to increased chloride ion influx into neurons, hyperpolarization, and decreased neuronal excitability. This results in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Onset
Onset of action is typically within 30-60 minutes.
Excretion
Mainly excreted in the urine as inactive metabolites (about 69% within 48 hours), with a small amount excreted in feces.
Half life
Elimination half-life ranges from 10 to 20 hours, with an average of about 12 hours.
Absorption
Rapidly and well absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1-2 hours after oral administration. Bioavailability is approximately 60%.
Metabolism
Extensively metabolized in the liver primarily by oxidative pathways (e.g., CYP3A4) to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to bromazepam or other benzodiazepines.
- Severe respiratory insufficiency (e.g., severe chronic obstructive pulmonary disease).
- Sleep apnea syndrome.
- Severe hepatic insufficiency.
- Myasthenia gravis (a neuromuscular disorder).
- Acute narrow-angle glaucoma.
Drug Interactions
Theophylline
May reduce the sedative effects of benzodiazepines.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine)
May increase bromazepam clearance, potentially reducing its therapeutic effect.
CNS Depressants (Alcohol, Opioids, Antidepressants, Antihistamines)
Increased sedative effect, respiratory depression, and risk of overdose. Avoid concomitant use or use with extreme caution.
CYP3A4 Inhibitors (e.g., Cimetidine, Fluvoxamine, Grapefruit Juice)
May decrease bromazepam clearance, leading to increased plasma concentrations and enhanced sedative effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, confusion, ataxia, diminished reflexes, and lethargy. In severe cases, hypotension, respiratory depression, coma, and rarely death can occur. Treatment is mainly supportive, involving gastric lavage (if recent ingestion) and monitoring vital signs. Flumazenil, a benzodiazepine receptor antagonist, may be used to reverse CNS depression, but it carries a risk of seizures in patients dependent on benzodiazepines.
Pregnancy & Lactation
Bromazepam should be avoided during pregnancy, especially during the first trimester, due to potential risks of congenital malformations. Use in late pregnancy or during labor may cause 'floppy infant syndrome' or withdrawal symptoms in the neonate. It is excreted in breast milk; therefore, use is generally not recommended during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date, check specific packaging for details.
Availability
Available in pharmacies worldwide
Approval Status
Approved in many countries globally
Patent Status
Off-patent, generic available
Clinical Trials
Extensive clinical trials have established the efficacy and safety of bromazepam for anxiety disorders. Ongoing research focuses on its long-term effects and potential for abuse.
Lab Monitoring
- For long-term use, periodic monitoring of liver function tests and blood counts may be considered.
Doctor Notes
- Bromazepam should be prescribed for the shortest possible duration to minimize the risk of dependence.
- Patients should be advised about the potential for sedation and impaired psychomotor skills, especially at the start of treatment.
- Gradual tapering is crucial when discontinuing to avoid withdrawal symptoms. Consider alternative non-pharmacological treatments for anxiety.
Patient Guidelines
- Do not stop taking bromazepam abruptly, as this can lead to withdrawal symptoms. Gradual dose reduction is necessary under medical supervision.
- Avoid alcohol consumption while taking this medication, as it can increase sedative effects.
- Report any unusual or severe side effects to your doctor immediately.
- Do not exceed the prescribed dose.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Bromazepam can cause drowsiness, dizziness, and impaired judgment, significantly affecting the ability to drive or operate machinery. Patients should be warned against performing such tasks.
Lifestyle Advice
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and impair coordination. Avoid activities requiring mental alertness.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine
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