TOPAMAX 25 TABLET 25 MG

CILAG AG - SWITZERLANDLUSOMEDICAMENTA - SOCIEDADE TÉCNICA FARMACÊUTICA S.A. (PRIMARY AND SECONDARY PACKAGER) (PORTUGAL)🇸🇬 Health Sciences Authority

Approval Date: Mar 24, 1998
Approval ID: b55a8a3de640ef99
Company: CILAG AG - SWITZERLANDLUSOMEDICAMENTA - SOCIEDADE TÉCNICA FARMACÊUTICA S.A. (PRIMARY AND SECONDARY PACKAGER) (PORTUGAL)
Type: Therapeutic

Approval Details

Approval Id: b55a8a3de640ef99
Drug Name: TOPAMAX 25 TABLET 25 MG
Product Name: TOPAMAX 25 TABLET 25 MG
Approval Number: SIN09688P
Approval Date: 1998-03-24
Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence Holder: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: Dosage and Administration Dosage 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. Epilepsy – adjunctive therapy <ul> <li>Adults Therapy should begin at 25 to 50 mg nightly for one week. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25 to 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 to 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 Warnings and Precautions – Renal Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Children aged 2 and above The recommended total daily dose of TOPAMAX® 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.</li> </ul> Epilepsy – monotherapy 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 (see Warnings and Precautions – Withdrawal of Topamax® – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When enzyme inducing drugs are withdrawn, topiramate levels will increase. A decrease in TOPAMAX® dosage may be required if clinically indicated. <ul> <li>Adults 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. Dose and titration rate should be guided by clinical outcome. 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.</li> <li>Children aged 2 and above 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. Dose and dose titration rate should be guided by clinical outcome. The recommended initial target dose range for topiramate monotherapy in children aged two 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.</li> </ul> Migraine <ul> <li>Adults 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. The recommended total daily dose of topiramate as treatment for prophylaxis of migraine headache is 100 mg/day administered in two divided doses. 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.</li> </ul> Special populations Renal impairment Patients with renal impairment (CLCR <70mL/min) may require a dose reduction. Half of the usual starting and maintenance dose is recommended (see Pharmacokinetic Properties – Special populations, Renal impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Since TOPAMAX® is removed from plasma by hemodialysis, a supplemental dose of TOPAMAX® equal to approximately one-half the daily dose should be administered on hemodialysis days. The supplemental dose should be administered in divided doses at the beginning and completion of the hemodialysis procedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used (see Pharmacokinetic Properties – Special populations, Renal impairment – 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 – Special populations, Hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Administration TOPAMAX® (topiramate) is available in tablets for oral administration. It is recommended that TOPAMAX® tablets not be broken. TOPAMAX® can be taken without regard to meals.
Route Of Administration: ORAL
Indication Info: Indications Epilepsy TOPAMAX® is indicated as monotherapy for adults and children with partial onset seizures and generalized seizures, including tonic-clonic seizures. TOPAMAX® 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. Migraine TOPAMAX® is also indicated for adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX® in the acute treatment of migraine headache has not been studied.
Contraindications: Contraindications Hypersensitivity to any component of this product. Migraine prophylaxis: in pregnancy and in women of childbearing potential if not using a highly effective method of contraception.
Atc Code: N03AX11
Atc Item Name: topiramate
Pharma Manufacturer Name: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/johnson-and-johnson-international-singapore-pte-ltd

Active Ingredients

TOPIRAMATE

25 mg

TOPIRAMATE

25 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 24, 1998

Approval ID

b55a8a3de640ef99

Type

Therapeutic

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