TEGRETOL 200 TABLET 200 mg

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET

**DOSAGE REGIMEN AND ADMINISTRATION** **Method of administration** The tablets and the oral suspension (to be shaken before use) may be taken during, after, or between meals. Tablets should be taken with a little liquid, and possible remnants of the chewable tablets should be washed down with a little liquid. The CR tablets (either whole or, if so prescribed, only half a tablet) should be swallowed unchewed with a little liquid. The chewable tablets and the oral suspension (one measure = 5 mL = 100 mg; half a measure = 2.5 mL = 50 mg) are particularly suitable for patients who have difficulty in swallowing tablets or need initial careful adjustment of the dosage. As a result of slow, controlled release of the active substance from the CR tablets, these are designed to be taken in a twice-daily dosage regimen. Since a given dose of Tegretol oral suspension will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses and increase them slowly so as to avoid adverse reactions. Switching patients from Tegretol tablets to oral suspension: this should be done by giving the same number of mg per day in smaller, more frequent doses (e.g. oral suspension three times a day (t.i.d.) instead of tablets twice a day (b.i.d)). Switching patients from conventional tablets to CR tablets: clinical experience shows that in some patients the dosage in the form of CR tablets may need to be increased. **Epilepsy** When possible, Tegretol should be prescribed as monotherapy. Treatment should be initiated with a low daily dosage, to be slowly increased until an optimal effect is obtained. 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 WARNINGS AND PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 sections INTERACTIONS AND CLINICAL PHARMACOLOGY – PHARMACOKINETICS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **General target population / Adults** **Dosage in Epilepsy** Initially, 100 to 200 mg once or twice daily; the dosage should be slowly raised until – generally at 400 mg 2 to 3 times daily – an optimum response is obtained. In some patients 1600 mg or even 2000 mg daily may be appropriate. **Dosage in Acute mania and maintenance treatment of bipolar affective disorders** Dosage range: about 400 to 1600 mg daily, the usual dosage being 400 to 600 mg daily given in 2 to 3 divided doses. In acute mania, the dosage should be increased rather quickly, whereas small dosage increments are recommended for maintenance therapy of bipolar disorders in order to ensure optimal tolerability. **Dosage in Alcohol-withdrawal syndrome** Average dosage: 200 mg 3 times daily. In severe cases, it can be raised during the first few days (e.g. to 400 mg 3 times daily). At the start of treatment for severe withdrawal manifestations, Tegretol should be given in combination with sedative-hypnotic drugs (e.g. clomethiazole, chlordiazepoxide). After the acute stage has abated, Tegretol can be continued as monotherapy. **Dosage in Trigeminal neuralgia** The initial dosage of 200 to 400 mg should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 mg/day. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. **Dosage in Painful diabetic neuropathy** Average dosage: 200 mg 2 to 4 times daily. **Dosage in Diabetes insipidus centralis** Average dosage for adults: 200 mg 2 to 3 times daily. In children the dosage should be reduced proportionally to the child's age and body weight. **Special populations** **Renal impairment / Hepatic impairment** No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function. **Pediatrics / Children and adolescents** **Dosage in Epilepsy** **Oral forms** For children aged 4 years or less, a starting dose of 20 to 60 mg/day, increasing by 20 to 60 mg every second day, is recommended. For children over the age of 4 years, therapy may begin with 100 mg/day, increasing at weekly intervals by 100 mg. Maintenance dosage: 10 to 20 mg/kg body weight daily in divided doses, e.g. Up to 1 year of age100 to 200 mg daily (= 5 to 10 mL 1–2 measures of oral suspension)1 to 5 years of age200 to 400 mg daily (= 10 to 20 mL 2× 1–2 measures of oral suspension)6 to 10 years of age400 to 600 mg daily (= 20 to 30 mL 2–3× 2 measures of oral suspension)11 to 15 years of age600 to 1000 mg daily (= 30 to 50 mL 3× 2–3 measures of oral suspension (plus an extra measure of 5 mL in case of administration of 1000 mg))>15 years of age:800 to 1200 mg daily (same as adult dose). **Maximum recommended 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. **Suppositories** When suppositories are used instead of oral forms, the maximum daily dose is limited to 1000 mg (250 mg q.i.d. at 6-hour intervals). No clinical data are available on the use of suppositories in indications other than epilepsy. **Dosage in Diabetes insipidus centralis** In children the dosage should be reduced proportionally to the child's age and body weight. Average dosage for adults: 200 mg 2 to 3 times daily. **Geriatric patients (66 years and above)** **Dosage in Trigeminal neuralgia** Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Tegretol should be selected with caution in elderly patients. In elderly patients, an initial dose of 100 mg twice daily is recommended. The initial dosage of 100 mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 mg/day. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.