Zeptol CR
Generic Name
Carbamazepine (Controlled Release)
Manufacturer
Popular Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zeptol cr 200 mg tablet | ৳ 7.00 | ৳ 70.00 |
| zeptol cr 400 mg tablet | ৳ 8.52 | ৳ 85.20 |
Description
Overview of the medicine
Zeptol CR is an extended-release formulation of Carbamazepine, an anticonvulsant medication used to treat various types of seizures, trigeminal neuralgia, and bipolar disorder. Its controlled-release nature helps maintain stable drug levels in the body.
Uses & Indications
Dosage
Adults
Epilepsy: Initially 200 mg orally twice daily, increasing weekly by 200 mg/day as needed. Usual maintenance: 800-1200 mg/day in 2-3 divided doses. Trigeminal Neuralgia: Initially 100 mg orally twice daily, increasing by 100 mg every 12 hours as needed. Usual maintenance: 200-400 mg twice daily. Bipolar Disorder: Initially 200 mg orally twice daily, increasing slowly to 400-800 mg/day.
Elderly
Lower initial doses and slower titration may be needed due to increased sensitivity and potential for adverse effects. Monitor carefully for side effects.
Renal_impairment
No specific dose adjustment for mild to moderate impairment, but monitor serum levels. Use with caution in severe impairment.
How to Take
Take orally, with or without food. Tablets should be swallowed whole; do not crush, chew, or divide, as this can affect the controlled-release properties.
Mechanism of Action
Carbamazepine primarily acts by stabilizing the inactivated state of voltage-gated sodium channels, thereby inhibiting repetitive neuronal firing and reducing the spread of seizure activity. It also has effects on calcium channels and neurotransmitter systems.
Pharmacokinetics
Onset
Slow, typically within hours to days for therapeutic effect.
Excretion
Primarily renal (72%), some fecal (28%).
Half life
Initially 25-65 hours, decreasing to 12-17 hours with chronic use due to autoinduction.
Absorption
Slow and variable absorption, prolonged with CR formulation. Bioavailability is 75-89%.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, to an active metabolite (10,11-epoxide). Exhibits autoinduction of its own metabolism.
Side Effects
Contraindications
- Hypersensitivity to carbamazepine or tricyclic antidepressants
- History of bone marrow depression
- Concomitant use with MAO inhibitors or within 14 days of discontinuing them
- Porphyria
Drug Interactions
Lithium
Increased risk of neurotoxicity when used concurrently.
Warfarin
May decrease warfarin levels, requiring closer INR monitoring.
Grapefruit Juice
Can increase carbamazepine levels.
Oral Contraceptives
Carbamazepine can reduce the effectiveness of oral contraceptives due to enzyme induction.
CYP3A4 Inducers/Inhibitors
Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, diltiazem) can increase carbamazepine levels. Strong CYP3A4 inducers (e.g., rifampin, phenytoin) can decrease carbamazepine levels.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include dizziness, drowsiness, nausea, vomiting, nystagmus, ataxia, blurred vision, tremor, disturbed consciousness, coma, seizures, respiratory depression, and cardiac conduction abnormalities. Management involves gastric lavage, activated charcoal, and supportive care. Hemodialysis may be considered.
Pregnancy & Lactation
Pregnancy Category D. Carbamazepine is associated with an increased risk of birth defects (e.g., spina bifida). Use only if benefits outweigh risks. It passes into breast milk; monitor infants for adverse effects. Discuss with a doctor.
Side Effects
Contraindications
- Hypersensitivity to carbamazepine or tricyclic antidepressants
- History of bone marrow depression
- Concomitant use with MAO inhibitors or within 14 days of discontinuing them
- Porphyria
Drug Interactions
Lithium
Increased risk of neurotoxicity when used concurrently.
Warfarin
May decrease warfarin levels, requiring closer INR monitoring.
Grapefruit Juice
Can increase carbamazepine levels.
Oral Contraceptives
Carbamazepine can reduce the effectiveness of oral contraceptives due to enzyme induction.
CYP3A4 Inducers/Inhibitors
Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, diltiazem) can increase carbamazepine levels. Strong CYP3A4 inducers (e.g., rifampin, phenytoin) can decrease carbamazepine levels.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include dizziness, drowsiness, nausea, vomiting, nystagmus, ataxia, blurred vision, tremor, disturbed consciousness, coma, seizures, respiratory depression, and cardiac conduction abnormalities. Management involves gastric lavage, activated charcoal, and supportive care. Hemodialysis may be considered.
Pregnancy & Lactation
Pregnancy Category D. Carbamazepine is associated with an increased risk of birth defects (e.g., spina bifida). Use only if benefits outweigh risks. It passes into breast milk; monitor infants for adverse effects. Discuss with a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 2-3 years from manufacturing date
Availability
Pharmacies in Bangladesh
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Carbamazepine has been extensively studied since its introduction, with numerous clinical trials establishing its efficacy and safety for its approved indications. Studies continue to explore its long-term effects and optimal use.
Lab Monitoring
- Complete blood count (CBC) with differential before and periodically during treatment
- Liver function tests (LFTs) before and periodically during treatment
- Serum carbamazepine levels, especially during initiation and dose adjustments
- Serum sodium levels periodically
Doctor Notes
- Emphasize the importance of patient counseling regarding potential severe skin reactions and hematologic adverse events.
- Monitor serum drug levels, CBC, LFTs, and sodium levels regularly.
- Counsel female patients of childbearing potential about reduced efficacy of hormonal contraceptives and the need for alternative birth control methods.
Patient Guidelines
- Take this medicine regularly as prescribed by your doctor.
- Do not suddenly stop taking this medicine without consulting your doctor, as it can worsen your condition.
- Report any unusual bleeding, bruising, fever, rash, or mouth sores to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once.
Driving Precautions
This medicine can cause dizziness, drowsiness, and blurred vision, especially at the beginning of treatment. Avoid driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Avoid alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Be cautious when performing activities requiring mental alertness, especially at the start of treatment.
- Maintain regular follow-up appointments for blood tests and monitoring.
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