Tegretol Tablets 100mg, 200mg, 400mg Ref.[2613] Active ingredients: Carbamazepine

Tegretol is given orally, usually in two or three divided doses. Tegretol may be taken during, after or between meals, with a little liquid e.g. a glass of water.

Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome (See information on genetic testings and cutaneous reactions in section 4.4).

Epilepsy

Adults: It is advised that with all formulations of Tegretol, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. It may be helpful to monitor the plasma concentration of carbamazepine to establish the optimum dose (see Pharmacokinetics, Precautions and Interactions).

Tegretol should be taken in a number of divided doses although initially 100-200mg once or twice daily is recommended. This may be followed by a slow increase until the best response is obtained, often 800-1200mg daily. In some instances, 1600mg or even 2000mg daily may be necessary.

Elderly: Due to the potential for drug interactions, the dosage of Tegretol should be selected with caution in elderly patients.

Children: It is advised that with all formulations of Tegretol, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. It may be helpful to monitor the plasma concentration of carbamazepine to establish the optimum dose, (see Pharmacokinetics, Precautions and Interactions).

Usual dosage 10-20mg/kg bodyweight daily taken in several divided doses.

Tegretol tablets are not recommended for very young children.

5-10 years: 2-3 × 200mg tablets per day, to be taken in divided doses.

10-15 years: 3-5 × 200mg tablets per day, to be taken in several divided doses.

Wherever possible, anti-epileptic agents should be prescribed as the sole anti-epileptic agent but if used in polytherapy the same incremental dosage pattern is advised.

When Tegretol is added to existing antiepileptic therapy, this should be done gradually while maintaining or, if necessary, adapting the dosage of the other antiepileptic(s) (see 4.5 Interaction with other Medicaments and other forms of Interaction).

Trigeminal neuralgia

Slowly raise the initial dosage of 200-400mg daily (100mg twice daily in elderly patients) until freedom from pain is achieved (normally at 200mg 3-4 times daily). In the majority of patients a dosage of 200mg 3 or 4 times a day is sufficient to maintain a pain free state. In some instances, doses of 1600mg Tegretol daily may be needed. However, once the pain is in remission, the dosage should be gradually reduced to the lowest possible maintenance level.

For the prophylaxis of manic depressive psychosis in patients unresponsive to lithium therapy

Initial starting dose of 400mg daily, in divided doses, increasing gradually until symptoms are controlled or a total of 1600mg given in divided doses is reached. The usual dosage range is 400-600mg daily, given in divided doses.

Signs and symptoms

The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular or respiratory systems.

Central nervous system: CNS depression; disorientation, somnolence, agitation, hallucination, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, initially hyperreflexia, later hyporeflexia; convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis.

Respiratory system: Respiratory depression, pulmonary oedema.

Cardiovascular system: Tachycardia, hypotension and at times hypertension, conduction disturbance with widening of QRS complex; syncope in association with cardiac arrest.

Gastro-intestinal system: Vomiting, delayed gastric emptying, reduced bowel motility.

Renal function: Retention of urine, oliguria or anuria; fluid retention, water intoxication due to ADH-like effect of carbamazepine.

Laboratory findings: Hyponatraemia, possibly metabolic acidosis, possibly hyperglycaemia, increased muscle creatine phosphokinase.

Treatment

There is no specific antidote.

Management should initially be guided by the patient’s clinical condition; admission to hospital. Measurement of the plasma level to confirm carbamazepine poisoning and to ascertain the size of the overdose.

Evacuation of the stomach, gastric lavage, and administration of activated charcoal. Delay in evacuating the stomach may result in delayed absorption, leading to relapse during recovery from intoxication.Supportive medical care in an intensive care unit with cardiac monitoring and careful correction of electrolyte imbalance.

Special recommendations

Hypotension: Administer dopamine or dobutamine i.v.

Disturbances of cardiac rhythm: To be handled on an individual basis.

Convulsions: Administer a benzodiazepine (e.g. diazepam) or another antiepileptic, e.g. phenobarbitone (with caution because of increased respiratory depression) or paraldehyde.

Hyponatraemia (water intoxication): Fluid restriction and slow and careful NaCl 0.9% infusion i.v. These measures may be useful in preventing brain damage.

Charcoal haemoperfusion has been recommended. Forced diuresis, haemodialysis, and peritoneal dialysis have been reported to be not effective.

Relapse and aggravation of symptomatology on the 2nd and 3rd day after overdose, due to delayed absorption, should be anticipated.

36 months.

Do not store above 25°C.

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

Tegretol 100mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets.

Tegretol 200mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets.

Tegretol 400mg come in PVC/PE/PVDC blister packs of 56.

Not all pack sizes may be marketed.

None.