TROKENDI XR

Absorption and

DistributionLinear pharmacokinetics of topiramate from TROKENDI XR ® were observed following a single oral dose over the range of 50 mg to 200 mg. At 25 mg, the pharmacokinetics of TROKENDI XR ® is nonlinear possibly due to the binding of topiramate to carbonic anhydrase in red blood cells. The peak plasma concentrations (C max ) of topiramate occurred at approximately 24 hours following a single 200 mg oral dose of TROKENDI XR ® . At steady-state, the (AUC 0-24 , C max , and C m...

14.1 Bridging Study to Demonstrate Pharmacokinetic Equivalence between Extended-Release and Immediate-Release Topiramate Formulations The basis for approval of the extended-release formulation (TROKENDI XR ® ) included the studies described below using an immediate-release formulation and the demonstration of the pharmacokinetic equivalence of TROKENDI XR ® to immediate-release topiramate through the analysis of concentrations and cumulative AUCs at multiple time points [see Clinical Pharmacology (12.6) ]. The clinical studies described in the following sections were conducted using immediate-...

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma [see Warnings and Precautions (5.1) ] Visual Field Defects [see Warnings and Precautions 5.2 ] Oligohydrosis and Hyperthermia [see Warnings and Precautions (5.3) ] Metabolic Acidosis [see Warnings and Precautions (5.4) ] Interaction With Alcohol [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (...

TROKENDI XR ® is contraindicated in patients with recent alcohol use (i.e., within 6 hours prior to and 6 hours after TROKENDI XR ® use) [see Warnings and Precautions (5.5) ] With recent alcohol use, i.e., within 6 hours prior to and 6 hours after TROKENDI XR ® use ( 4 , 5.5 )

Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue TROKENDI XR ® as soon as possible ( 5.1 ) Visual field defects: consider discontinuation of TROKENDI XR ( 5.2 ) Oligohydrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients ( 5.3 ) Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of TROKENDI XR ® if clin...

7 DRUG INTERACTIONS Contraceptives: Decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg per day ( 7.5 ) Monitor lithium levels if lithium is used with high-dose TROKENDI XR ( 7.8 ) 7.1 Alcohol Alcohol use is contraindicated within 6 hours prior to and 6 hours after TROKENDI XR ® administration [see Contraindications (4) and Warnings and Pre...