Pradox Special Precautions

Antiepileptics are associated with an increased risk of suicidal behavior/thoughts with use (regardless of indication); patients should be monitored for signs/symptoms of depression, suicidal tendencies, and other unusual behavior changes during therapy and instructed to inform their healthcare provider immediately if symptoms occur. Use with caution in patients with hepatic, respiratory or renal impairment. Topiramate may decrease serum bicarbonate concentrations (up to 67% of patients); treatment-emergent metabolic acidosis is less common. Risk may be increased in patients with a predis­posing condition (organ dysfunction, ketogenic diet, or concurrent treatment with, other drugs which may cause acidosis). Metabolic acidosis may occur at dosages as low as 50 mg/day. Monitor serum bicarbonate as well as potential complications of chronic acidosis (nephrolithiasis, osteomalacia, and reduced growth rates in children). Kid­ney stones have been reported in both children and adults; the risk of kidney stones is about 2-4 times that of the untreated population; the risk of this event may be reduced by increasing fluid intake.
Cognitive dysfunction, psychiatric disturbances (mood dis­orders), and sedation (somnolence or fatigue) may occur with topiramate use; incidence may be related to rapid titration and higher doses. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Topiramate may also cause paresthesia, dizziness, and ataxia. Topiramate has been associated with acute myopia and secondary angle­ closure glaucoma in adults and children, typically within 1 month of initiation; discontinue in patients vvith acute onset of decreased visual acuity or ocular pain. Hyperammone­mia with or without encephalopathy may occur with or without concomitant valproate administration; valproic acid dose-dependency was observed in limited pediatric stud­ies; use with caution in patients with inborn errors of metabolism or decreased hepatic mitochondrial activity. Topiramate may be associated (rarely) with severe oligo­hydrosis and hyperthermia, most frequently in children; use caution and monitor closely during strenuous exercise, during exposure to high environmental temperature, or in patients receiving receiving other carbonic anhydrase inhibitors and drugs with anticholinergic activity. Concur­rent use of topiramate and hydrochlorothiazide may increase the risk for hypokalemia; monitor potassium closely.
Avoid abrupt withdrawal of topiramate therapy, it should be withdrawn/tapered slowly to minimize the potential of increased seizure frequency. Doses were also gradually withdrawn in migraine prophylaxis studies. Effects with other sedative drugs or ethanol may be potentiated. Safety and efficacy have not been established in children <2 years of age for adjunctive treatment of·seizure and <10 years of age for monotherapy treatment of seizures. In pediatric patients, weight loss may occur most often early in therapy; in clinical trials of at least 1 year, the majority of patients with weight loss had a resumption of weight gain within the study period. Safety and efficacy have not been established in children for migraine prophylaxis.