Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
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).
The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (See section 4.4).
It is advised that with all formulations of Taver, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient.
Taver 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.
Due to the potential for drug interactions the dosage of Taver should be selected with caution in elderly patients.
Children and adolescents:
It is advised that with all formulations of Taver, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient.
Usual dosage 10-20mg/kg bodyweight daily taken in several divided doses.
Taver tablets are not recommended for very young children.
5-10 years: 400 mg to 600 mg daily (2-3 × 200mg tablets per day, to be taken in divided doses).
Children 10-15 years: 600 to 1000mg daily (3-5 × 200mg tablets per day, to be taken in several divided doses).
>15 years of age: 800 to 1200mg daily (same as adult dose).
Maximum recommended dose:
Up to 6 years of age: 35mg/kg/day
6-15 years of age: 1000mg/day
>15 years of age: 1200mg/day.
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 Taver is added to existing antiepileptic therapy, this should be done gradually while maintaining or, if necessary, adapting the dosage of the other antiepileptics (see section 4.5).
Slowly raise the initial dosage of 200-400mg daily 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 Taver daily may be needed. However, once the pain is in remission, the dosage should be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
Dosage in Trigeminal neuralgia:
Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Taver should be selected with caution in elderly patients.
In elderly patients, an initial dose of 100mg twice daily is recommended. The initial dosage of 100mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
For the prophylaxis of manicdepressive psychosis in patients unresponsive to lithium therapy:
Initial starting dose of 400 mg 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 mg- 600 mg daily, given in divided doses.
Renal impairment/Hepatic impairment:
No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function.
Taver is given orally, usually in two or three divided doses. Taver may be taken during, after or between meals, with a little liquid e.g. a glass of water.
The presenting signs and symptoms of overdosage involve the central nervous, cardiovascular, respiratory systems and the adverse drug reactions mentioned under section 4.8.
Central nervous system: CNS depression; disorientation, depressed level of consciousness, 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.
Musculoskeletal system: There have been some cases which reported rhabdomyolysis in association with carbamazepine toxicity.
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 creatinine phosphokinase.
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.
Charcoal haemoperfusion has been recommended. Hemodialysis is the effective treatment modality in the management of the carbamazepine overdose.
Relapse and aggravation of symptomatology on the 2nd and 3rd day after overdose, due to delayed absorption, should be anticipated.
60 months.
Store below 25°C, in the original package.
PVC-Alu blisters in carton packs of 50 tablets.
None.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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