CJN volume 30 issue S2 Cover and Back matter

0 mg Tablets and 15 and 25 mg Sprinkle Capsules Antiepileptic INDICATIONS AND CLINICAL USE TOPAMAX (topiramote] is indicated as adjunctive therapy for the management of potients (adults and children two years and older) with epilepsy who are not satisfactorily controlled with conventional therapy.There is limited information on the use of topiromate in monotherapy at this time.CONTRAINDICATIONS TOPAMAX (topiromate) is contraindicated in potients with o history of hypersensitivity to any components of this product. WARNINGSAntiepileptic drugs, including TOPAMAX (topiromate), should be withdrawn gradually to minimize the potential of increased seizure frequency.In adult clinical trials, dosoges were decreased by 100 mg/doy at weekly intervals. Central Nervous System EffectsAdverse everts most often associated with the use of TOPAMAX were central nervous system-related.In adults, the most significant of these can be classified into two general categories: i) psychomotor slowing: difficulty with concentration and speech or language problems, in particular, word-finding difficulties and ii) somnolence or fatigue.Additional nonspecific CNS effects occasionally observed with topiromate as add-on theiapy include dizziness or imbalance, confusion, memory problems, and exacerbation of mood disturbances (e.g.irritability and depression).These events were generally mild to moderate, and generally occurred early in theiapy.While the incidence of psychomotor slowing does not appear to be dose related, both language problems and difficulty with concentration or attention increased in frequency with increasing dosage in the six double-blind trials, suggesting that these events are dose related.(See ADVERSE REACTIONS.) PRECAUTIONS Effects Related to Carbonk Anhydrqse InhibitionKidney Stones A total of 32/1,71 5 (1.5%) of patients exposed to TOPAMAX (topiromate) during its development reported the occurrence of kidney stones, an incidence about 10 times that expected in a similar, untreated population (M/F ratio: 27/1,092 male; 5/623 female).In the general population, risk foctors for kidney stone formation include gender (male), oges between 20-50 years, prior stone formotion, family history of nephrolithiasis, and hypercalciuria.Based on logistic regression analysis of the clinical trial dota, no correlation between mean topiromate dosage, duration of topiromate therapy, or age ond the occurrence of kidney stones was established; of the risk factors evaluated, only gender (male) showed a correlation with the occurrence of kidney stones.In the pediatric potients studied, there were no kidney stones observed.Carbonic onhydrase inhibitors, B.g. acetozolamide, promote stone formation by reducing urinary citrate excretion ond by increosing urinary pH.Concomitant use of TOPAMAX, a weak carbonic anhydrase inhibitor, with other carbonic onhydrase inhibitors may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.Patients, especially those with a predisposition to nephrolithiasis, may have an increased risk of renal stone formation.Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation.Therefore, adequate hydration is recommended to reduce this risk.None of the risk factors for nephrolithiasis con reliably predict stone formation during TOPAMAX treatment.Paresthesia: Paresthesia, an effect associated with the use of other carbonic anhydrose inhibitors, appears to be a common effect of TOPAMAX therapy.These events were usually intermittent and mild, and not necessarily related to the dosage of topirnmote.10.4 10.1 ropenia CtJ 27 L2Patients in these addon trials were receiving 1 to 2 concomitont ontiepileptic drags in addition to TOPAMAX topirnmote or placebo.Values represent the percentage of patients reporting a given adverse event.Potients may have reported more than oae adverse event during the study and can be included in more thon one adverse eveat category.

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