Carbamazepine is indicated for:

• Partial seizures and secondary generalized tonic-clonic seizures
• Primary generalized tonic-clonic seizures
• Trigeminal neuralgia
• Prevention of bipolar disorder

Carbamazepine reduces neuronal excitability by acting on the ventral nucleus of the thalamus. It inhibits the spread of excitatory impulses and limits repetitive neuronal firing, possibly by restricting sodium ion movement across cell membranes. Additionally, it enhances the release of antidiuretic hormone (ADH) and increases its effect, thereby promoting water reabsorption.

Epilepsy:

• Adults and children over 12 years of age- Initial: Either 200 mg b.i.d. for tablets and controlled release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d or a t.i.d. or q.i.d. regimen of the either formulations until the optimal response is obtained.
• Children 12-15 years of age- Dosage generally should not exceed 1000 mg daily, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: usually 800-1200 mg daily.
• Children 6-12 years of age- Initial: Either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d or a t.i.d or q.i.d. regimen of the either formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: usually 400-800 mg daily.
• Children under 6 years of age- Initial: 10-20 mg/kg/day b.i.d or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

Combination therapy: Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased.

Trigeminal Neuralgia: Initial: On the first day, either 100 mg b.i.d. for tablets or controlled release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or controlled release tablets, or 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. A total dose of 1200 mg daily shouldn’t be exceeded. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. The tablets or syrup can be taken without regards to meal.

This medication should not be used in individuals with hypersensitivity to carbamazepine or any of its components. It is also contraindicated in the following conditions:

• Atrioventricular (AV) conduction disorders
• History of bone marrow depression
• Porphyrias (hereditary blood disorders)
• Known hypersensitivity to tricyclic antidepressants
• Use of monoamine oxidase inhibitors (MAOIs) within the past 14 days

Common side effects include dizziness, drowsiness, unsteadiness (ataxia), dry mouth, abdominal pain, nausea, vomiting, loss of appetite, reduced white blood cells (leucopenia), protein in urine, slow heart rate (bradycardia), heart failure, and low blood pressure. Skin rash and aplastic anemia may also occur.

Serious adverse reactions may involve the blood-forming system, skin, and cardiovascular system. The most frequently observed reactions, especially during the early phase of treatment, include dizziness, drowsiness, lack of coordination, nausea, and vomiting. Carbamazepine may increase sensitivity to sunlight. Patients should avoid excessive exposure to sunlight, sunlamps, or tanning devices. Use of sunscreen or protective clothing is recommended during prolonged outdoor exposure.

Pregnancy Category D. Carbamazepine and its active metabolite are excreted into breast milk. Due to the risk of serious adverse effects, a decision should be made whether to discontinue breastfeeding or stop the medication.

This medication may cause dizziness and drowsiness. Patients should exercise caution while performing tasks that require alertness, such as driving or operating machinery.

Skin reactions may occur during treatment. If rash, peeling, itching, or any unusual skin changes develop, medical advice should be sought immediately.

Rarely, this drug may affect liver function. Patients should consult a physician if symptoms such as itching, yellowing of skin or eyes, dark urine, nausea, vomiting, abdominal pain, loss of appetite, or flu-like symptoms occur.

Carbamazepine may reduce the effectiveness of hormonal contraceptives containing estrogen and/or progesterone, potentially leading to contraceptive failure or breakthrough bleeding.

Women who require contraception while taking this medication should use preparations containing at least 50 micrograms of estrogen or consider non-hormonal methods such as barrier protection.

Treatment should not be stopped abruptly unless advised by a physician, as sudden discontinuation may worsen symptoms. If discontinuation is necessary, it should be done gradually under medical supervision.

Caution is advised in:

• Mixed seizure disorders including absence seizures
• Elderly patients
• History of heart disease
• History of kidney disease
• History of liver disease
• History of psychiatric illness
• Increased intraocular pressure (e.g., glaucoma)
• History of drug-induced blood disorders
• Previous discontinuation of carbamazepine due to adverse reactions or allergy

Primary anti-epileptic drugs

Store below 30°C, away from light and moisture. Keep out of the reach of children.