CJN volume 29 issue S1 Cover and Back matter

a Topamax topiramote 25, 100 and 2 0 0 mg Tablets and T5 and 25 mg Sprinkle Capsules Antiepileptic INDICATIONS AND CLINICAL USETOPAMAX (fopframate) is indicoted os adjunctive therapy fat the management of patients (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 topiromote in monotherapy at this time. CONTRAINDICATIONSTOPAMAX (topiramote) is contrcindicoted in patients with a history of hypersensitivity to any components of this product.WARNINGS Antiepileptic drugs, including TOPAMAX (topiramote), should be withdrawn gradually to minimize the potential of increased seizure frequency.In adult clinical triols, dosoges were decreased by 100 mg/day ct weekly intervals.Central Nervoui Syitem Effects Adverse events most often associoted with the use of TOPAMAX were central nervous system-relored.In odults, the most significant of these con be classified into two general categories: i) psychomotor slowing: difficulty with concentration ond speech or language problems, in particular, wordfinding difficulties and ii) somnolence or fatigue.Additional nonspecific CNS effects occasionally observed with topiramote as ockf-on therapy 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 therapy.While the incidence of psychomotoi 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 ttiat these events are dose related.(See ADVERSE REACTIONS.)Acute Myopia ond Secondary Angle Closure Glaucoma A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX.Symptoms include acute onset of decreased visual acuity and/or oarlor pain.Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure.Mydriasis may or may not be present.This syndrome may be associated with supracitiory effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.Spptoms typically occur within o few days to 1 month of initiating TOPAMAX therapy.In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramote has been reported in pediatric patients as well as adults.The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgement of the treating physician.Other measures, in conjunction with discontinuation of TOPAMAX moy be helpful (see PRECAUTIONS and Post-Marketing Adverse Reactions).In all cases of acute visual blurring and/or painful/red eye(s), immediate consultation with an ophthalmologist is recommended.Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequolae including permanent vision loss.PRECAUTIONS Effects Related to Carbonic Anhydrase Inhibition Kidney Stones A total of 32/1,715 (1.5 : :) of potients exposed toTOPAMAX (topiromote) during its development reported the occurrence of kidney stones, on 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 factors for kidney stone formation include gender (mole), ages between 20-50 years, prior stone formation, family history of nephrolithiasis, ond hypercalciuria.Based on logistic regression analysis of the clinical trial data, no correlation between mean topiromote dosage, duration of topiramote therapy, or age and 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 patients studied, there were no kidney stones observed.Carbonic anhydrase inhibitors, e.g.acetozolomide, promote stone formation by reducing urinary citrate excretion and by increasing urinary pH.Concomitant use of TOPAMAX, a weak carbonic onhydrose inhibitor, with other carbonic anhydrase inhibitors may create a physiological environment that increases the risk of kidney stone formation, ond should therefore be avoided.Potients, especially those with a predisposition to nephrolithiasis, may have on 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 can reliably predict stone formation during TOPAMAX treotment.Paresthesia Paresthesia, an effect associated with the use of other carbonic anhydrase 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 topiramote.Nutritional Supplementation A dietary supplement or increased food intake may be considered if the patient is losing weight while on this medication. Weight Loss in PediatricsTopiromote administration is associoted with weight loss in some children that generally occurs early in therapy.Of those pediatric subjects treated in dinical trials for at least o year who experienced weight loss, 96;i showed a resumption of weight gain within the period tested.In 2-4 year olds, the mean change in weight from baseline ot 12 months (n=25) was +07 kg (range -I.I to 3.2); at 24 months (n=!4), the meon change was +2.2 (range -1.1 to 6.1).In 5-10 year olds, the meon change in weight from baseline at 12 months (n=88) was +0.7 kg {range -6.7 to 11.8); ot 24 months (n=67), the mean change was +3,3 (range -8.6 to 20.0).Weight decreases, usuotly associated with anorexia or appetite changes, were reported as adverse events for 9?: of topiramote-treated pediatric patients.The long term effects of reduced weight gain in pediatric patients is not known. Adjustment of Dose in Renol failureThe major route of elimination of unchanged topiramote and its metabolites is via the kidney.Renal elimination is dependent on renal function and is independent of oge.Patients with impaired renal function (CLCR < 70 mL/min/1.73m1 ) or with end-stage renal disease receiving hemodialysis treatments moy take 10 to 15 days to reach steadysfate plasma concentrations os compared to 4 to 8 days in patients with normal renal function.As with all patients, the titration schedule should be guided by clinical outcome (i.e.seizure control, avoidance of side effects) with the knowledge that patients with known renol impairment moy require a longer time to reach steodystate at each dose.(See DOSAGE AND ADMINISTRATION.)Decreased Hepatic Function In hepaticalry impaired patients, topiramote should be administered with caution as the clearance of topiramote was decreased compared with normal subjects. 2Patients in these addon trials were receiving 1 to 2 concomitant antiepilepn'c drugs in addition to TOPAMAX topiramnte or phrcebo.Volues represent the percentage of patients reporting a given odverse event.Patients may have reported more than one adverse event during the study and caa be included in more than one adverse event category.dosing regimen of phenytoin

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