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Click on icon to see table/diagram/imagePediatric Patients Ages 6 to 9 Years of Age: Dosing in patients 6 to 9 years of age is based on weight. During the titration period, the initial dose of Topiramate (Trokendi 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/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 mg to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (see Table 6).
Click on icon to see table/diagram/imageDosing in Adjunctive Therapy Epilepsy: Adults (17 Years of Age and Older): The recommended total daily dose of Topiramate (Trokendi 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 6 to 16 Years of Age: The recommended total daily dose of Topiramate (Trokendi XR) as adjunctive therapy for patients 6 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 in Migraine Prophylaxis: The recommended total daily dose of Topiramate (Trokendi XR) as treatment for prophylaxis of migraine headache in patients 12 years of age and older is 100 mg once daily. Titrate Topiramate (Trokendi XR) for migraine prophylaxis according to the following schedule: (see Table 7).
Click on icon to see table/diagram/imageAdministration with Alcohol: Alcohol use should be completely avoided within 6 hours prior to and 6 hours after Topiramate (Trokendi XR) administration (see Interaction with Alcohol under Precautions).
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 of Topiramate (Trokendi XR) is recommended (see Use in the Elderly and Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions).
Dosage Modifications in Patients Undergoing Hemodialysis: To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of Topiramate (Trokendi XR) may be required. The actual adjustment should take into account: the duration of dialysis period; the clearance rate of the dialysis system being used; the effective renal clearance of topiramate in the patient being dialyzed (see Patients Undergoing Hemodialysis under Precautions and Pharmacology: Pharmacokinetics under Actions).
Administration Instructions: Topiramate (Trokendi XR) can be taken without regard to meals.
Swallow capsule whole and intact. Do not sprinkle on food, chew, or crush.
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