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Tegretol

Tegretol Dosage/Direction for Use

carbamazepine

Manufacturer:

Novartis

Distributor:

DCH Auriga - Healthcare
Full Prescribing Info
Dosage/Direction for Use
Dosage in special clinical situations: Elderly patients: Due to possible drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Tegretol should be selected with caution in elderly patients.
An initial dose of 100 mg twice daily is recommended.
Patients who are potential carriers of the HLA-A*3101 allele because of their ancestry: Before initiating treatment with Tegretol it is recommended that patients at risk of certain adverse skin/hypersensitivity reactions because of their ancestry be tested for the presence of the HLA-A*3101 allele to improve risk assessment (see Precautions).
Epilepsy: Tegretol should be prescribed as monotherapy whenever possible.
Treatment should be initiated with a low daily dosage, slowly increasing until an optimum effect is achieved.
Particularly in the case of combination therapy, the therapeutic dose should be based both on a determination of plasma levels and on efficacy. Experience has shown that therapeutic levels of carbamazepine lie between 4 and 12 μg/ml.
When Tegretol is added to existing antiepileptic therapy, this should be done gradually while maintaining, or if necessary adapting, the dosage of the other drug(s) (see Interactions).
Adults: Oral forms: Initially 100-200 mg once or twice daily, slowly increasing until an optimum response is achieved - generally with 400 mg two or three times daily (corresponding to 800-1200 mg). In some patients, 1600 mg or even 2000 mg daily may be appropriate, although these high doses should be avoided due to a greater incidence of adverse effects.
Children and adolescents: Oral suspension: 10-20 mg carbamazepine per kg bodyweight per day, in divided doses, i.e.*: Up to 1 year of age: 100-200 mg/day (= 5-10 ml = 1-2 spoonfuls).
1-5 years of age: 200-400 mg/day (= 10-20 ml = 2 × 1-2 spoonfuls).
6-10 years of age: 400-600 mg/day (= 20-30 ml = 2-3 × 2 spoonfuls).
11-15 years of age: 600-1000 mg/day (= 30-50 ml = 3 × 2-3 spoonfuls).
>15 years of age: 800-1200 mg/day (same as daily dose in adults).
* 1 measuring spoonful contains 100 mg of carbamazepine in 5 ml of suspension.
Maximum recommended daily dose: Up to 6 years of age: 35 mg/kg/day.
6-15 years of age: 1000 mg/day.
>15 years of age: 1200 mg/day.
A starting dose of 20-60 mg/day, increasing by 20-60 mg every second day, is recommended for children 4 years of age or younger. For children over 4 years of age, treatment may be started at 100 mg/day, increasing by 100 mg at weekly intervals.
Trigeminal neuralgia: The starting dose of 200-400 mg/day (in elderly patients, 100 mg twice daily) should be increased gradually until freedom from pain is achieved (normally with 200 mg three to four times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. The maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.
Alcohol-withdrawal syndrome: Patients should be given 200 mg three to four times daily on the first two days of treatment. In severe cases, the dosage may be increased to 1200 mg/day during the first few days of treatment. The dosage should subsequently be reduced slowly until treatment is concluded (see change of treatment under Precautions).
Acute mania and maintenance treatment of bipolar affective disorders: Dosage range: approx. 400-1600 mg daily. The normal daily dose is 400-600 mg, given in 2-3 divided doses. The dosage should be increased fairly rapidly in acute mania, whereas small increments are recommended for maintenance therapy of bipolar disorders to ensure optimal tolerability.
Further dosage instructions: The oral suspension (which should be shaken before use!) and the tablets may be taken - with liquid - during, after or between meals. The CR tablets (either a whole or, if so prescribed, half a tablet) should be swallowed unchewed with liquid.
The oral suspension (1 spoonful = 5 ml = 100 mg; ½ spoonful = 2.5 ml = 50 mg) is particularly suitable for patients who have difficulty swallowing tablets. The oral suspension is also suitable for patients who require careful initial dose titration.
CR tablets can normally be administered twice daily owing to the slow, controlled release of active substance from the tablets.
Since a given dose of oral suspension will produce higher peak plasma concentrations than the same dose in tablet form, it is advisable to start the oral suspension at a low dosage, which should then be increased slowly to avoid adverse effects.
Switching dosage forms: Switching from Tegretol tablets to Tegretol oral suspension: This should be done by giving the same daily dose, but in smaller, more frequent doses (e.g. oral suspension three times daily, instead of tablets twice daily).
Switching from standard tablets to CR tablets: Clinical experience shows that the dosage may need to be increased in some patients.
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