TOPIRON FILM-COATED TABLETS 50MG [SIN14131P]

Product Info

TOPIRON FILM-COATED TABLETS 50MG

[SIN14131P]

4.1. Therapeutic indications

Topiramate is indicated as monotherapy in adults and children with partial onset seizures and generalised seizures including tonic-clonic seizures.

Topiramate is indicated as adjunctive therapy for adults and children with partial onset seizures or generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.

Topiramate is also indicated in adults for the prophylaxis of migraine headache. The usefulness of Topiramate in the acute treatment of migraine headache has not been studied.

4.2. Posology and method of administration

General

For optimal seizure control in both adults and children, it is recommended that therapy be initiated at a low dose followed by titration to an effective dose.

Topiron is available in a film-coated tablet formulation. It is recommended that film-coated tablets not be broken.

Topiron can be taken without regard to meal

Monotherapy epilepsy

General
When concomitant antiepileptic drugs (AEDs) are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control. Unless safety concerns require an abrupt withdrawal of the concomitant AED, a gradual discontinuation at the rate of approximately one-third of the concomitant AED dose every 2 weeks is recommended.

When enzyme inducing drugs are withdrawn, topiramate levels will increase. A decrease in topiramate dosage may be required if clinically indicated.

Adults

Dose and titration rate should be guided by clinical outcome. Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used.

The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day and the maximum recommended daily dose is 500 mg. Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1,000 mg/day. These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease.

Paediatric population (aged 2 years and above)

Dose and dose titration rate in children should be guided by clinical outcome. Treatment of children aged 2 years and above should begin at 0.5 to 1 mg/kg nightly for the first week. The dosage should then be increased at 1- or 2- week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses. If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used.

The recommended initial target dose range for topiramate monotherapy in children aged 2 years and above is 3 to 6 mg/kg/day. Children with recently diagnosed partial onset seizures have received doses of up to 500 mg/day.

Adjunctive therapy epilepsy

Adults

Therapy should begin at 25–50 mg nightly for one week. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25–50 mg/day and taken in two divided doses. Dose titration should be guided by clinical outcome. Some patients may achieve efficacy with once-a-day dosing.

In clinical trials as adjunctive therapy, 200 mg was effective and was the lowest dosage studied. This is therefore considered the minimum effective dose. The usual daily dose is 200–400 mg in two divided doses. Individual patients have received doses as high as 1600 mg/day.

These dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population (children aged 2 years and above)

The recommended total daily dose of topiramate as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.

Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.

Migraine

The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg/day administered in two divided doses. Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased in increments of 25 mg/day administered at 1-week intervals. If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used. Some patients may experience a benefit at a total daily dose of 50 mg/day. Patients have received a total daily dose up to 200 mg/day. Dose and titration rate should be guided by clinical outcome.

General dosing recommendations for Topiron in special patient populations

Renal impairment

Patients with moderate and severe renal impairment may require a dose reduction. Half of the usual starting and maintenance dose is recommended (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Hemodialysis

Since topiramate is removed from plasma by haemodialysis, a supplemental dose of Topiramate equal to approximately one-half the daily dose should be administered on haemodialysis days. The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Topiramate should be administered with caution in patients with hepatic impairment (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3. Contraindications

Migraine prophylaxis: in pregnancy and in women of childbearing potential if not using a highly effective method of contraception.

Hypersensitivity to the active substance or to any of the excipients.