Drug Detail:Qudexy xr sprinkle (Topiramate [ toe-pyre-a-mate ])
Generic Name: Topiramate 25mg
Dosage Form: capsule, extended release
Drug Class: Carbonic anhydrase inhibitor anticonvulsants
Dosing in Monotherapy Epilepsy
Adults and Pediatric Patients 10 Years of Age and Older
The recommended dose for QUDEXY XR monotherapy in adults and pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate QUDEXY XR according to the following schedule (see Table 1).
| QUDEXY XR Once Daily Dose | |
|---|---|
| Week 1 | 50 mg |
| Week 2 | 100 mg |
| Week 3 | 150 mg |
| Week 4 | 200 mg |
| Week 5 | 300 mg |
| Week 6 | 400 mg |
Pediatric Patients 2 to 9 Years of Age
Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of QUDEXY XR is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day in the second week. Dosage can be increased by 25 mg to 50 mg once daily each subsequent week, as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 mg to 50 mg once daily weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (see Table 2).
| Weight (kg) | Total Daily Dose (mg/day) Minimum Maintenance Dose |
Total Daily Dose (mg/day) Maximum Maintenance Dose |
|---|---|---|
| Up to 11 | 150 | 250 |
| 12 to 22 | 200 | 300 |
| 23 to 31 | 200 | 350 |
| 32 to 38 | 250 | 350 |
| Greater than 38 | 250 | 400 |
Dosing in Adjunctive Therapy Epilepsy
Adults (17 Years of Age and Older)
The recommended total daily dose of QUDEXY XR as adjunctive therapy in adults with partial-onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily, and with primary generalized tonic-clonic seizures is 400 mg orally once daily. Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50 mg 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
The recommended total daily dose of QUDEXY XR as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (or less, based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Subsequently, increase the dosage at 1- or 2-week intervals by increments of 1 mg/kg/day to 3 mg/kg/day to achieve optimal clinical response. Dose titration should be guided by clinical outcome. The total daily dose should not exceed 400 mg/day.
Dosing for the Preventive Treatment of Migraine
The recommended total daily dose of QUDEXY XR as treatment for the preventive treatment of migraine in patients 12 years of age and older is 100 mg once daily. The recommended titration rate for QUDEXY XR for the preventive treatment of migraine is as follows:
| QUDEXY XR Once Daily Dose | |
|---|---|
| Week 1 | 25 mg |
| Week 2 | 50 mg |
| Week 3 | 75 mg |
| Week 4 | 100 mg |
Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustment can be used.
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 QUDEXY XR is recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].
Dosing in Patients Undergoing Hemodialysis
To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of QUDEXY XR 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)].
Administration Instructions
QUDEXY XR capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed or crushed. It should not be stored for further use. QUDEXY XR can be taken without regard to meals [see Clinical Pharmacology (12.3)].
