Epam
Generic Name
Clobazam 5 mg Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| epam 5 mg tablet | ৳ 0.75 | ৳ 30.00 |
Description
Overview of the medicine
Epam 5 mg Tablet contains Clobazam, a benzodiazepine primarily used for the short-term treatment of anxiety and as an adjunctive therapy for certain types of epilepsy, particularly Lennox-Gastaut syndrome. It acts by enhancing the effect of a natural chemical in the body (GABA) which reduces abnormal electrical activity in the brain.
Uses & Indications
Dosage
Adults
Anxiety: Initially 5-10 mg daily, usually divided doses, adjusted according to response, max 30 mg/day. Epilepsy: Initially 5-10 mg daily, gradually increased to 20-30 mg daily.
Elderly
Lower initial dose, e.g., 5 mg daily, gradually increased with caution due to increased sensitivity and potential for side effects.
Renal_impairment
Dose adjustment may be necessary. Initiate with a low dose and monitor carefully. Not recommended for severe impairment.
How to Take
Epam 5 mg Tablet should be taken orally with water, with or without food. It can be taken as a single dose at bedtime or in divided doses during the day.
Mechanism of Action
Clobazam binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA) type A receptor complex, enhancing the inhibitory effects of GABA. This leads to increased chloride ion influx, hyperpolarization of neurons, and consequently, reduced neuronal excitability.
Pharmacokinetics
Onset
Anxiolytic effects typically within 30-60 minutes; anticonvulsant effects may take longer, especially when titrating.
Excretion
Mainly renal, with about 80% of metabolites excreted in urine and 11% in feces.
Half life
Parent drug: approximately 18 hours. Active metabolite (N-desmethylclobazam): approximately 42-80 hours.
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached within 1-4 hours.
Metabolism
Primarily hepatic, mainly by CYP3A4 and CYP2C19 to its active metabolite N-desmethylclobazam. Also undergoes glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to Clobazam or other benzodiazepines.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
- Myasthenia gravis.
- Sleep apnea syndrome.
Drug Interactions
CYP3A4 inducers (e.g., rifampicin, carbamazepine)
May decrease Clobazam plasma concentrations.
CYP2C19 inhibitors (e.g., fluvoxamine, omeprazole)
May increase Clobazam plasma concentrations, requiring dose adjustment.
Opioids, other CNS depressants (alcohol, barbiturates, antidepressants, antihistamines)
Increased risk of sedation, respiratory depression, and hypotension.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, diminished reflexes, and coma. Severe cases may lead to respiratory depression and hypotension. Management involves supportive care, gastric lavage/activated charcoal if recent ingestion, and potentially flumazenil (benzodiazepine receptor antagonist) with caution.
Pregnancy & Lactation
Pregnancy Category D: May cause fetal harm. Avoid during pregnancy, especially during the first trimester and near term. Use during lactation is generally not recommended as it is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to Clobazam or other benzodiazepines.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
- Myasthenia gravis.
- Sleep apnea syndrome.
Drug Interactions
CYP3A4 inducers (e.g., rifampicin, carbamazepine)
May decrease Clobazam plasma concentrations.
CYP2C19 inhibitors (e.g., fluvoxamine, omeprazole)
May increase Clobazam plasma concentrations, requiring dose adjustment.
Opioids, other CNS depressants (alcohol, barbiturates, antidepressants, antihistamines)
Increased risk of sedation, respiratory depression, and hypotension.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, diminished reflexes, and coma. Severe cases may lead to respiratory depression and hypotension. Management involves supportive care, gastric lavage/activated charcoal if recent ingestion, and potentially flumazenil (benzodiazepine receptor antagonist) with caution.
Pregnancy & Lactation
Pregnancy Category D: May cause fetal harm. Avoid during pregnancy, especially during the first trimester and near term. Use during lactation is generally not recommended as it is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Clobazam has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of anxiety and as an adjunctive therapy for epilepsy. Ongoing research explores its role in other neurological conditions.
Lab Monitoring
- Liver function tests (especially with long-term use)
- Complete blood count (rarely for prolonged use)
Doctor Notes
- Emphasize the importance of gradual dose reduction when discontinuing to minimize withdrawal symptoms.
- Assess for history of substance abuse prior to initiating therapy due to abuse potential.
- Monitor for signs of respiratory depression, especially when used concomitantly with opioids or in patients with pre-existing respiratory issues.
Patient Guidelines
- Do not stop taking this medicine abruptly without consulting your doctor, as it can lead to withdrawal symptoms.
- Avoid alcohol and other CNS depressants while on this medication.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- This medicine may cause drowsiness; avoid driving or operating heavy machinery until you know how it affects you.
Missed Dose Advice
If a dose is missed, 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 regular dosing schedule. Do not double the dose to compensate for a missed one.
Driving Precautions
Epam may cause drowsiness, dizziness, and impaired coordination. Patients should be warned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.
Lifestyle Advice
- Avoid consuming alcohol as it enhances the sedative effects.
- Practice good sleep hygiene to manage anxiety.
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Global Brand Names
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