Zeptol CR
Generic Name
Carbamazepine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zeptol cr 400 mg tablet | ৳ 8.52 | ৳ 85.20 |
Description
Overview of the medicine
Zeptol CR 400 mg Tablet contains Carbamazepine, an anticonvulsant medication. It is primarily used to treat epilepsy (seizures), trigeminal neuralgia (a type of facial nerve pain), and bipolar disorder (a mental health condition characterized by extreme mood swings). The 'CR' in its name indicates a controlled-release formulation, which allows for a slower and more sustained release of the active ingredient, reducing the frequency of dosing.
Uses & Indications
Dosage
Adults
Epilepsy: Initial 200 mg twice daily (CR), gradually increase at weekly intervals by 200 mg/day until optimal response, typically 800-1200 mg/day. Trigeminal Neuralgia: Initial 100 mg twice daily (CR), gradually increase at weekly intervals by 100 mg/day until pain relief, typically 400-800 mg/day. Bipolar Disorder: Initial 200 mg twice daily (CR), gradually increase to target 400-1600 mg/day.
Elderly
Lower initial doses and slower titration are recommended due to increased sensitivity and potential for comorbidities. Monitor closely for adverse effects.
Renal_impairment
No specific dose adjustment is generally required, but close monitoring of renal function and carbamazepine plasma levels is advisable due to potential accumulation of metabolites.
How to Take
Take Zeptol CR tablets orally with food to reduce gastrointestinal upset. Do not crush, chew, or divide extended-release tablets; they should be swallowed whole.
Mechanism of Action
Carbamazepine stabilizes hyperexcited nerve membranes, inhibits repetitive neuronal discharges, and reduces the synaptic propagation of excitatory impulses. Its primary mechanism of action involves blocking voltage-gated sodium channels, thereby limiting the sustained repetitive firing of action potentials.
Pharmacokinetics
Onset
Therapeutic effects for epilepsy and bipolar disorder may take several days to weeks to manifest fully. For trigeminal neuralgia, pain relief can begin within hours.
Excretion
Approximately 72% excreted in urine (mostly as metabolites) and 28% in feces.
Half life
Initial half-life is 25-65 hours; with chronic use, autoinduction of metabolism reduces it to 12-17 hours.
Absorption
Slowly and completely absorbed from the gastrointestinal tract. Peak plasma concentrations are typically reached within 12-24 hours for extended-release formulations.
Metabolism
Primarily hepatic, via the CYP3A4 enzyme system, to an active metabolite, carbamazepine-10,11-epoxide. Carbamazepine is also a potent autoinducer of its own metabolism.
Side Effects
Contraindications
- Known hypersensitivity to Carbamazepine or any component of the formulation, or to tricyclic antidepressants.
- History of bone marrow depression.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOIs.
- Porphyria.
Drug Interactions
Lithium
Increased risk of neurotoxicity when used concomitantly with lithium.
Warfarin
Reduced anticoagulant effect of warfarin due to increased metabolism.
CYP3A4 Inducers
Decrease carbamazepine plasma levels (e.g., rifampin, phenytoin, phenobarbital).
CYP3A4 Inhibitors
Increase carbamazepine plasma levels (e.g., erythromycin, diltiazem, grapefruit juice).
Oral Contraceptives
Decreased efficacy of hormonal contraceptives, leading to breakthrough bleeding or unintended pregnancy.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include dizziness, ataxia, drowsiness, nausea, vomiting, nystagmus, convulsions, respiratory depression, and coma. Management involves gastric lavage, activated charcoal, and supportive care for vital functions. Close monitoring of cardiac and respiratory status is essential.
Pregnancy & Lactation
Pregnancy Category D. Carbamazepine is associated with an increased risk of congenital malformations (e.g., spina bifida). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Folic acid supplementation is recommended. Carbamazepine is excreted in breast milk; monitor breastfed infants for potential side effects such as drowsiness or poor feeding.
Side Effects
Contraindications
- Known hypersensitivity to Carbamazepine or any component of the formulation, or to tricyclic antidepressants.
- History of bone marrow depression.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOIs.
- Porphyria.
Drug Interactions
Lithium
Increased risk of neurotoxicity when used concomitantly with lithium.
Warfarin
Reduced anticoagulant effect of warfarin due to increased metabolism.
CYP3A4 Inducers
Decrease carbamazepine plasma levels (e.g., rifampin, phenytoin, phenobarbital).
CYP3A4 Inhibitors
Increase carbamazepine plasma levels (e.g., erythromycin, diltiazem, grapefruit juice).
Oral Contraceptives
Decreased efficacy of hormonal contraceptives, leading to breakthrough bleeding or unintended pregnancy.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include dizziness, ataxia, drowsiness, nausea, vomiting, nystagmus, convulsions, respiratory depression, and coma. Management involves gastric lavage, activated charcoal, and supportive care for vital functions. Close monitoring of cardiac and respiratory status is essential.
Pregnancy & Lactation
Pregnancy Category D. Carbamazepine is associated with an increased risk of congenital malformations (e.g., spina bifida). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Folic acid supplementation is recommended. Carbamazepine is excreted in breast milk; monitor breastfed infants for potential side effects such as drowsiness or poor feeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Carbamazepine has been extensively studied in numerous clinical trials since its introduction for epilepsy, trigeminal neuralgia, and bipolar disorder. Ongoing research includes studies on its use in specific patient populations, long-term safety, and comparisons with newer antiepileptic drugs.
Lab Monitoring
- Complete Blood Count (CBC) with differential (prior to and periodically during treatment due to risk of blood dyscrasias).
- Liver Function Tests (LFTs) (prior to and periodically during treatment).
- Renal Function Tests (RFTs) (periodically).
- Serum sodium levels (periodically due to risk of hyponatremia).
- Carbamazepine plasma levels (to optimize dosing and avoid toxicity, therapeutic range typically 4-12 mcg/mL).
- HLA-B*1502 genetic testing (recommended for patients of Asian descent before initiation of therapy).
Doctor Notes
- Emphasize the importance of patient adherence and regular follow-up for blood counts, LFTs, and plasma levels.
- Counsel patients on the early signs and symptoms of serious dermatologic reactions and blood dyscrasias, instructing them to seek immediate medical attention if they occur.
- Advise female patients of childbearing potential about the risks during pregnancy and the need for effective contraception.
- Warn about significant drug interactions, particularly with CYP3A4 inhibitors/inducers and hormonal contraceptives.
Patient Guidelines
- Do not stop taking Zeptol CR abruptly, as this can lead to withdrawal seizures or worsening of underlying conditions. Consult your doctor for gradual dose reduction.
- Report any unusual skin rash, fever, sore throat, mouth ulcers, easy bruising, or bleeding to your doctor immediately, as these could be signs of serious adverse reactions.
- Avoid alcohol consumption while taking this medication, as it can increase drowsiness and dizziness.
- Take your medication consistently with food at the same time each day to maintain stable drug levels.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Zeptol CR may cause dizziness, drowsiness, blurred vision, or impaired coordination, especially at the start of treatment or after dose adjustments. Avoid driving, operating machinery, or performing other hazardous tasks until you are certain you can do so safely.
Lifestyle Advice
- Maintain a regular sleep schedule to help manage mood and seizure control.
- Avoid activities that require high alertness, such as driving or operating heavy machinery, until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Inform all your healthcare providers, including dentists, about your carbamazepine use.
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