Qudexy XR Capsules Dosage
Generic name: Topiramate 25mg
Dosage form: capsule, extended release
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Adults and Pediatric Patients 10 Years and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures
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 (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 less than 10 Years with Partial Onset or Primary Generalized Tonic-Clonic Seizures
Dosing in patients 2 to less than 10 years is based on weight. During the titration period, the initial dose of QUDEXY XR should be 25 mg once daily given at nighttime for the first week. Based upon tolerability, the dosage can be increased to 50 mg once daily 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 in weekly increments by 25 mg to 50 mg once daily, up to the maximum recommended maintenance dose for each range of body weight (see Table 2).
|Weight (kg)||Once Daily Dose (mg per day) Minimum Maintenance Dose||Once Daily Dose (mg per 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|
Adjunctive Therapy Use
Adults (17 Years of Age and Older) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
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. The recommended total dose for adults 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. Daily topiramate doses above 1,600 mg have not been studied.
In the study of primary generalized tonic-clonic seizures using topiramate, the assigned dose was reached at the end of 8 weeks [see Clinical Studies (14.4)].
Pediatric Patients (Ages 2 Years to 16 Years) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of QUDEXY XR as adjunctive therapy for pediatric patients 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 (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 to 3 mg/kg to achieve optimal clinical response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.
Dose Modifications 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 is recommended. Such patients will require a longer time to reach steady-state at each dose [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Prior to dosing, obtain an estimated creatinine clearance (CrCl) in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease). CrCl can be estimated using the following equation (multiply by 0.85 for women):
|CrCl||=||(140 – age) × weight(kg)
SerumCr(mg / dl) × 72
Dosage Modifications in Patients Undergoing Hemodialysis
Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in patients with normal renal function. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. 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 the:
Laboratory Testing Prior to Treatment Initiation
Measurement of baseline and periodic serum bicarbonate during QUDEXY XR treatment is recommended [see Warnings and Precautions (5.4)].
Dosing Modifications in Patients Taking Phenytoin and/or Carbamazepine
The co-administration of QUDEXY XR with phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with QUDEXY XR may require adjustment of the dose of QUDEXY XR [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
Monitoring for Therapeutic Blood Levels
It is not necessary to monitor topiramate plasma concentrations to optimize QUDEXY XR therapy.
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. Do not store drug/food mixture for further use. QUDEXY XR can be taken without regard to meals [see Clinical Pharmacology (12.3)].