Topamax

[Topiramate]

Pediatric Patients

In double-blind clinical studies, the incidences of cognitive/ neuropsychiatric adverse events in pediatric patients were generally lower than pre-viously observed in adults. These events included psychomotor slowing, difficulty with concentration/ attention, speech disorders/ related speech problems and language problems. The most frequently reported neuropsychiatric events in this population were somnolence and fatigue. No patients discontinued treatment due to adverse events in double-blind trials.

Sudden Unexplained Death in Epilepsy (SUDEP)

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During the course of premarketing development of TOPAMAX ® (topiramate) Tablets, 10 sudden and unexplained deaths were recorded among a cohort of treated patients (2,796 subject years of exposure). This represents an incidence of 0.0035 deaths per patient year. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving TOPAMAX ® (ranging from 0.0005 for the general population of patients with epilepsy, to 0.003 for a clinical trial population similar to that in the TOPAMAX ® program, to 0.005 for patients with refractory epilepsy).

PRECAUTIONS

General

Kidney Stones A total of 32/ 2,086 (1.5%) of adults exposed to topiramate during its development reported the occurrence of kidney stones, an incidence about 2-4 times greater than expected in a similar, untreated population. As in the general population, the incidence of stone formation among topiramate treated patients was higher in men. Kidney stones have also been reported in pediatric patients.

An explanation for the association of TOPAMAX ® and kidney stones may lie in the fact that topiramate is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors, e. g., acetazolamide or dichlorphenamide, promote stone formation by reducing urinary citrate excretion and by increas-ing urinary pH. The concomitant use of TOPAMAX ® with other carbonic anhydrase inhibitors or potentially in patients on a ketogenic diet may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.

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