CARZEPIN Tablet

For treatment of:

- Partial seizures with complex symptomatology (psychomotor, temporal lobe).

- Generalized tonic-clonic seizures (grand mal).

- Mixed seizure patterns.

- Pain due to trigeminal neuralgia and glossopharyngeal neuralgia.

Dosage and Administration

Adults

Anticonvulsant

- Initial: Oral, 200mg 2 times a day on the first day, the dosage then being increased as needed.

- Maintenance: Oral, 800-1200mg a day, in 3-4 divided doses.

Analgesic

- Initial: Oral, 100mg 2 times a day on the first day, the dosage then being increased as needed.

- Maintenance: Oral, 200-1200mg a day, in 3-4 divided doses.

Children

Anticonvulsant

Below 6 years

- Initial: Oral, 5mg/kg/day, the dosage being increased as needed.

- Maintenance: Oral, 10-20mg/kg/day, in 3-4 divided doses.

6-12 years

- Initial: 100mg 2 times a day on the first day, the dosage being increased as needed.

- Maintenance: Oral, 400-800mg a day in 3-4 divided doses, not exceeding 1g daily.

- Not recommended in patients with atrioventricular (AV) hear block, blood disorders, and history of bone marrow depression.

- Use in nursing mothers should generally be avoided.

Dizziness, drowsiness, ataxia, nausea or vomiting.

- Monoamine oxidase (MAO)

- Anticoagulants, coumarin or indandione derivative, doxycycline, or tricyclic antidepressants

- Oral contraceptives, barbiturates, benzodiazepines, hydantoins, primidone, succinimides, valproic acid

- Erythromycin, propoxyphene, troleandomycin

Safety for use in pregnancy has not been established.

- Caution in geriatric patients and in patients with coronary artery disease, diabetes mellitus, glaucoma, history of hematologic adverse reactions to other medications, urinary retention, cardiac, hepatic or renal disease.

- Abrupt discontinuation in a responsive epileptic patient may precipitate convulsions or status epilepticus; gradual withdrawal is recommended.

- Plasma carbamazepine concentration determinations is recommended periodically as a guide to efficacy and safely.

- Carbamazepine should be given with caution to patients who are hypersensitive to tricyclic antidepressants.

- This medication may cause drowsiness. Caution when driving or operating machinery. Avoid alcoholic beverages.

- Caution: Serious and sometimes fatal skin reactions, including toxic epidermal necrolysis (Lyell’s Syndrome) and Stevens-Johnson Syndrome have been known to occur during treatment with carbamazepine. They are significantly more common in patients with carbamazepine. They are significantly more common in patients with a particular human leucocyte antigen (HLA) allele, HLA-B1502, which occurs almost exclusively in patients with ancestry across broad areas of Asia. Patients should be screened for HLA-B1502 allele prior to initiating treatment with carbamazepine. If a patient tests positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine.

Patients treated with carbamazepine should closely be monitored for sign of hypersensitivity reactions, particularly during the first month of therapy. Immediate discontinuation of therapy should be mode when cutaneous reactions occur.

- Potential for an increase in risk of suicidal thoughts or behaviors.

Exact mechanism of action of carbamazepine as an anticonvulsant is unknown but it is believed to stabilize rather than elevate the seizure threshold and to limit the spread of seizure activity.

Oral absorption is slow but fairly complete and plasma protein binding is extensive. It undergoes hepatic metabolism and renal excretion.