Indications

Epilepsy - generalised tonic-clonic and partial seizures.

Note: Carbamazepine Tablet is not usually effective in absences (petit mal) and myoclonic seizures. can be used both as monotherapy and in combination with other anti-epileptic treatment. The paroxysmal pain of trigeminal neuralgia. For the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy.

Dosage and Administration

Usage: Oral

Epilepsy: The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate   control of seizures. Carbamazepine Tablet should be taken in a number of divided doses although initially 100 – 200 mg once or twice daily is recommended. This may be followed by a slow increase until the best response is obtained, often 800 - 1200mg daily.

Precautions & Warning:

1. Agranulocytosis and aplastic anaemia have been associated with carbamazepine

2. Decreased platelet or white blood cell counts occur occasionally to frequently in association with the use of carbamazepine

3. If the white blood cell or platelet count is definitely low or decreased during treatment, the patient and the complete blood count should be closely monitored .

4. Liver function tests should also be performed before commencing treatment and periodically thereafter, particularly in patients with a history of liver disease and in elderly patients.

5. Some liver function tests in patients receiving carbamazepine may be found to be abnormal, particularly gamma glutamyl transferase.

6. Severe hepatic reactions to carbamazepine occur very rarely.

7. Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.

8. Cutaneous reactions

Contraindications:

1.Hypersensitivity to the active substance or to any of the excipients or to structurally related substances (e.g. tricyclic antidepressants)

2. Patients with atrioventricular block

3. Patients with a history of bone marrow depression Patients with a history of hepatic porphyrias .The use of carbamazepine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs).

Adverse Reactions:

1. Blood and lymphatic system disorders:leucopenia; thrombocytopenia, eosinophilia.

2. Endocrine disorders: Oedema, fluid retention, weight increase, hyponatraemia and blood osmolarity decreased due to an antidiuretic hormone (ADH)-like effect, leading in rare cases to water intoxication accompanied by lethargy, vomiting, headache, confusional state, neurological disorders.

3. Nervous system disorders: ataxia, dizziness, somnolence. diplopia, headache.

4. Eye disorders: accommodation disorders (e.g. blurred vision)

5. Gastro-intestinal disorders: vomiting, nausea. dry mouth, with suppositories rectal irritation may occur.

6. Skin and subcutaneous tissue disorders: urticaria, which may be severe dermatitus allergic, dermatitis exfoliative.

7. General disorders and administration site conditions: fatigue.

8. Investigations: gamma-glutamyltransferase increased (due to hepatic enzyme induction), usually not clinically relevant. blood alkaline phosphatase increased.

Storage instructions:

Do not store above 25° C.

Store in the original package in order to protect from moisture.