TEGRETOL CR 400 TABLET 400 MG [SIN02388P]

Product Info

TEGRETOL CR 400 TABLET 400 MG

[SIN02388P]

INDICATIONS

• Epilepsy

  • Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization.

  • Generalized tonic-clonic seizures. Mixed forms of seizures.

  Tegretol is suitable for both monotherapy and combination therapy.

  Tegretol is usually not effective in absences (petit mal) and myoclonic seizures (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Acute mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.

• Alcohol-withdrawal syndrome.

• Idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis (either typical or atypical). Idiopathic glossopharyngeal neuralgia.

• Painful diabetic neuropathy.

• Diabetes insipidus centralis. Polyuria and polydipsia of neurohormonal origin.

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.

The CR tablets (either whole or, if so prescribed, only half a tablet) should be swallowed unchewed with a little liquid. The oral suspension (one measure = 5 mL = 100 mg; half a measure = 2.5 mL = 50 mg) is 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 1,600 mg or even 2,000 mg daily may be appropriate. However, the maximum daily dose of oral suspension is limited to 1,200 mg.

Dosage in Acute mania and maintenance treatment of bipolar affective disorders

Dosage range: about 400 to 1,600 mg daily, the usual dosage being 400 to 600 mg daily given in 2 to 3 divided doses. However, the maximum daily dose of oral suspension is limited to 1,200 mg. 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 and glossopharyngeal 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 1,200 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

Patients with hepatic or renal impairment

No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function.

Pediatric patients (below 18 years)

Dosage in Epilepsy

For children aged ≥ 4 weeks up to 4 years, 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.,

Maximum recommended dose

From ≥ 4 weeks up to 6 years of age: 35 mg/kg/day

6 to 15 years of age: 1,000 mg/day

>15 years of age: 1,200 mg/day.

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 (65 years of age or above)

Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Tegretol should be selected with caution in elderly patients.

Dosage in Trigeminal neuralgia

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 1,200 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.

CONTRAINDICATIONS

• Known hypersensitivity to carbamazepine or structurally related drugs (e.g., tricyclic antidepressants) or any other component of the formulation

• Patients with atrioventricular block

• Patients with a history of bone-marrow depression

• Patients with a history of hepatic porphyrias (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda)

• The use of Tegretol is contraindicated in combination with monoamine-oxidase inhibitors (MAOIs) (see section INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Neonates below 4 weeks of age (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).