risk of hyperammonemia (with or without encephalopathy). 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. 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 lansing mi airport parking coupons clearance (CrCl) in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease). Dosage can be increased by 25 mg to 50 mg once daily each subsequent week, as tolerated. Cautions, maintain adequate fluid intake due to kidney stone risk. 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. Risks of acute myopia and secondary angle-closure glaucoma (discontinue immediately if vision problems). 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. Pediatric Patients 2 to less than 10 Years with Partial Onset or Primary Generalized Tonic-Clonic Seizures. Rapid titration rate, dose, and higher initial dose associated with higher incidence of neuropsychiatric disorder in both epilepsy and migraine patients; also associated with higher incidences of cognitive-related dysfunction.
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Women of childbearing potential who are not planning a pregnancy should use effective contraception because of risks to fetus of oral clefts and of being small for gestational age. Hypothermia reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use; consideration should be given to stopping topiramate or valproate in patients who develop hypothermia. Table 2: Monotherapy Target Once Daily Maintenance Dosing for Patients 2 to Less Than 10 Years. Qudexy XR can be taken without regard to meals see Clinical Pharmacology (12.3). 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. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. Use caution when operating heavy machinery. 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. Annals of General Psychiatry.
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