Topiramate

TOPIRAMATE- topiramate tablet
Aphena Pharma Solutions — Tennessee, LLC

1. INDICATIONS AND USAGE

1.1 Monotherapy Epilepsy

Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.

1.2 Adjunctive Therapy Epilepsy

Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.

1.3 Migraine

Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.

2. DOSAGE AND ADMINISTRATION

2.1 Dosing in Monotherapy Epilepsy

Adults and Pediatric Patients 10 Years of Age and OlderThe recommended dose for topiramate monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. The dose should be achieved by titration according to the following schedule (Table 1):

Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older
Morning Dose Evening Dose
Week 1 25 mg 25 mg
Week 2 50 mg 50 mg
Week 3 75 mg 75 mg
Week 4 100 mg 100 mg
Week 5 150 mg 150 mg
Week 6 200 mg 200 mg

Pediatric Patients 2 to 9 Years of AgeDosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of topiramate is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2).

Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age
* Administered in two equally divided doses
Weight (kg) Total Daily Dose (mg/day)* Minimum Maintenance Dose Total Daily Dose (mg/day)* Maximum Maintenance Dose
Up to 11 150 250
12 — 22 200 300
23 — 31 200 350
32 — 38 250 350
Greater than 38 250 400

2.2 Dosing in Adjunctive Therapy Epilepsy

Adults (17 Years of Age and Older)

The recommended total daily dose of topiramate as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. Topiramate should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day have not been shown to improve responses in adults with partial onset seizures.

Pediatric Patients 2 to 16 Years of Age

2.3 Dosing for the Preventive Treatment of Migraine

The recommended total daily dose of topiramate as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). The recommended titration rate for topiramate for the preventive treatment of migraine is as follows:

Table 3: Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older

Morning Dose Evening Dose
Week 1 None 25 mg
Week 2 25 mg 25 mg
Week 3 25 mg 50 mg
Week 4 50 mg 50 mg

Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.

2.4 Administration Information

Topiramate can be taken without regard to meals.

Topiramate Tablets

2.5 Dosing in Patients with Renal Impairment

In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of topiramate is recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].

2.6 Dosing in Patients Undergoing Hemodialysis

To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

3. DOSAGE FORMS AND STRENGTHS

Topiramate tablets are available containing 25 mg, 50 mg, 100 mg or 200 mg of topiramate, USP.

The 25 mg tablets are white, film coated, round, biconvex tablets debossed with IG on one side and 278 on other.

The 50 mg tablets are yellow, film coated, round, biconvex tablets debossed with IG on one side and 279 on other.

The 100 mg tablets are light yellow, film coated, round, biconvex tablets debossed with IG on one side and 280 on other.

The 200 mg tablets are pink, film coated, round, biconvex tablets debossed with IG on one side and 281 on other.

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