The incidence of some adverse reactions (e.g., fatigue, dizziness, paresthesia, language problems, psychomotor slowing, depression, difficulty with concentration/attention, mood problems) was dose-related and much greater at higher than recommended topiramate dosing (i.e., 600 mg to 1000 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (200 mg to 400 mg daily) range.In controlled clinical trials in adults, 11% of patients receiving immediate-release topiramate 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions.

Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. It may harm them. The safety data presented below are from 249 patients with partial epilepsy on concomitant AEDs who participated in the QUDEXY XR study [see Clinical Studies ].

Topirimate, an antiepileptic (AED) drug, is commonly prescribed by doctors and has been on the market for over 20 years. Titrate QUDEXY XR according to the following schedule (see Table 1).Dosing in patients 2 to 9 years of age is based on weight. A population pharmacokinetic model was developed on the basis of pharmacokinetic data from relevant topiramate clinical studies.

The incidence of some adverse reactions (e.g., fatigue, dizziness, somnolence, difficulty with memory, difficulty with concentration/attention) was dose-related and greater at higher than recommended topiramate dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily).Of the 1135 patients exposed to immediate-release topiramate in the adult placebo-controlled studies, 25% discontinued due to adverse reactions, compared to 10% of the 445 placebo-treated patients. Similarly, topiramate half-life was longer (13%) in the elderly. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players . The UK Epilepsy and Pregnancy Register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) that was 16 times higher than the background rate in the UK (0.2%).Data from the NAAED pregnancy registry and a population-based birth registry cohort indicate that exposure to topiramate When topiramate (0, 20, 100, or 500 mg/kg/day) was administered orally to pregnant mice during the period of organogenesis, the incidence of fetal malformations (primarily craniofacial defects) were increased at all doses. The clinical relevance of this observation has not been established.A drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of hydrochlorothiazide (HCTZ) (25 mg every 24 hours) and topiramate (96 mg every 12 hours) when administered alone and concomitantly. This dataset contained data from 1217 subjects including 258 pediatric patients age 2 years to less than 16 years (95 pediatric patients less than 10 years of age).Pediatric patients on adjunctive treatment exhibited a higher oral clearance (L/h) of topiramate compared to patients on monotherapy, presumably because of increased clearance from concomitant enzyme-inducing antiepileptic drugs.

This difference was statistically significant.Figure 2 shows the change from baseline during titration plus maintenance (11 weeks) in partialonset seizure frequency by category for patients treated with QUDEXY XR and placebo. 0000004957 00000 n 0000024009 00000 n In Study 7, the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH [see Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation.