CARBATOL 200 MG 30 TAB

Indications

Approved Uses

Epilepsy (partial seizures and generalized tonic‑clonic seizures) and trigeminal neuralgia; glossopharyngeal neuralgia is also an approved use in many references; bipolar disorder/mania is not an approved indication for many carbamazepine tablet labels and is commonly treated off‑label depending on jurisdiction.

Dosage & Administration

Dosing by Condition

Epilepsy (adults, immediate‑release): start 200 mg twice daily (or 100-200 mg 1-2 times daily) and increase gradually; usual maintenance 800-1200 mg/day in divided doses; max commonly 1600 mg/day. Trigeminal neuralgia: start 100 mg twice daily (or 200 mg/day) and increase gradually; usual 400-800 mg/day; max 1200 mg/day. Bipolar disorder/acute mania (off‑label in many settings): commonly start 200 mg twice daily (or 400 mg/day) and titrate; typical range 400-1600 mg/day (max often 1600 mg/day).

Initial Dose

100-200mg once or twice daily, titrated gradually

Maintenance Dose

Epilepsy: 800-1200 mg/day. Trigeminal Neuralgia: 400-800 mg/day.

Maximum Dose

Typically 1200 mg/day for adjunctive therapy; up to 2400 mg/day for monotherapy conversion in adults

Dose Adjustment Notes

Titrate gradually; avoid abrupt discontinuation; carbamazepine induces its own metabolism (auto‑induction) over ~3-5 weeks so dose/levels may need reassessment; use caution in hepatic impairment (often requires dose reduction/close monitoring) and in renal impairment (generally caution/monitoring rather than routine adjustment).

How to Take

Oral: swallow the film‑coated tablet whole with water; may be taken with food to reduce GI upset; for immediate‑release carbamazepine, administer in divided doses (typically 2-4 times daily) as prescribed.

Side Effects

Common Side Effects

Dizziness, drowsiness/somnolence, ataxia/unsteadiness, nausea/vomiting, diplopia/blurred vision, headache, and rash; constipation and dry mouth can occur.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to carbamazepine or tricyclic antidepressants; bone marrow depression; concomitant MAOIs or within 14 days; atrioventricular (AV) block; acute hepatic porphyria (e.g., acute intermittent porphyria).

Age Restriction

Approved for pediatric use; no absolute minimum age, but dosing is age/weight-based and should be specialist-guided in young children.

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

May take with food to reduce GI upset; avoid grapefruit/grapefruit juice because it can increase carbamazepine concentrations via CYP3A4 inhibition.

Alcohol Interaction

Avoid

Special Populations

Kidney Impairment

No routine renal dose adjustment; use caution in severe renal impairment and monitor levels/clinical response and sodium.

Liver Impairment

Use with caution in hepatic impairment with close monitoring; avoid/contraindicated in severe hepatic disease; no fixed dose adjustment-individualize based on clinical response and labs.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly; taper gradually over several weeks (individualize; often weeks to months in epilepsy) to reduce risk of rebound seizures.

Overdose

Symptoms: CNS depression (drowsiness, ataxia, nystagmus, seizures, coma), anticholinergic effects, and cardiac conduction/arrhythmias/respiratory depression; Management: emergency care with airway/ventilation, ECG monitoring, activated charcoal (often multiple-dose), supportive care-no specific antidote; consider extracorporeal removal in severe/life-threatening cases per toxicology advice.

Patient Counseling

Take CARBATOL (carbamazepine) exactly as prescribed; do not stop suddenly (risk of seizure recurrence). Take with food if stomach upset occurs. Avoid grapefruit/grapefruit juice and limit/avoid alcohol (increased CNS effects and interaction). May cause dizziness, drowsiness, blurred/double vision and ataxia-use caution with driving/operating machinery until effects are known. Seek urgent care for rash/blistering/peeling, mouth sores, fever/sore throat, unusual bruising/bleeding, facial swelling, or yellowing of skin/eyes (SJS/TEN, blood dyscrasias, hypersensitivity, hepatic injury). Keep scheduled monitoring (CBC, LFTs, sodium as clinically indicated). Use effective contraception; carbamazepine reduces hormonal contraceptive effectiveness-use a non-hormonal or additional barrier method and discuss pregnancy planning/teratogenic risk with the prescriber.

Monitoring Requirements

Baseline and periodic: CBC (including platelets), liver function tests, serum sodium (hyponatremia/SIADH risk); consider serum carbamazepine concentrations (typical therapeutic range ~4-12 mcg/mL) when assessing efficacy/toxicity or interactions; monitor for rash and clinical signs of blood dyscrasias/hepatotoxicity; renal function as clinically indicated.

Pharmacology

Mechanism of Action

Use‑dependent blockade of voltage‑gated sodium channels (preferentially binding the inactivated state), stabilizing neuronal membranes and reducing repetitive firing; additional effects are secondary and less clinically defining.

Duration of Effect

Immediate‑release carbamazepine typically requires dosing every 6-12 hours (2-4 times daily) to maintain effect; extended‑release products allow longer intervals.

Half-Life

Initial (single dose): ~25-65 hours; after repeated dosing/auto-induction: ~12-17 hours.

Bioavailability

Approximately 70-85% (oral bioavailability; variable).

Metabolism

Hepatic, primarily via CYP3A4, to an active metabolite (carbamazepine-10,11-epoxide). It is a potent autoinducer of its own metabolism.

Protein Binding

76%

Product Information

Available Dosage Forms

Carbamazepine is available (by product) as immediate‑release tablets (including film‑coated), chewable tablets, extended‑release tablets/capsules, and oral suspension; this specific product is a 200 mg film‑coated tablet for oral use.

Composition per Dose

Each film-coated tablet: 200mg carbamazepine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Neuropathic Pain, Mood Stabilization, Trigeminal Neuralgia, Alcohol Withdrawal, Restless Legs Syndrome

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