EPRONTIA

Peak topiramate plasma concentrations (C max ) occurred at approximately 0.5 hour after oral administration of EPRONTIA in healthy male subjects under fasting conditions. Oral administration of EPRONTIA with a high-fat and high calorie meal did not affect topiramate AUC 0-t and AUC 0-∞ , but lowered the C max by 28% and delayed the T max by 5 hours. Overall, the impact of food-intake on topiramate pharmacokinetics is not expected to be clinically significant, and therefore, EPRONTIA can be admin...

The safety and efficacy of EPRONTIA are based on the relative bioavailability of EPRONTIA compared to topiramate sprinkle capsules in healthy subjects [see Clinical Pharmacology ( 12.3 )] . Topiramate sprinkle capsules have comparable bioavailability to topiramate tablets. The studies described in the following subsections were conducted using topiramate tablets or sprinkle capsules. 14.1 Monotherapy Epilepsy Patients with Partial-Onset or Primary Generalized Tonic-Clonic Seizures Adults and Pediatric Patients 10 Years of Age and Older The effectiveness of topiramate as initial monotherapy in ...

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

None. None ( 4 ).

Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue EPRONTIA as soon as possible ( 5.1 ). Visual field defects: consider discontinuation of EPRONTIA ( 5.2 ). Oligohidrosis 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 EPRONTIA if clinically app...

7 DRUG INTERACTIONS Contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day ( 7.4 ). Monitor lithium levels if lithium is used with high-dose EPRONTIA ( 7.7 ). 7.1 Antiepileptic Drugs Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentration...