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The majority of the reports have been in children. Patients, especially pediatric patients, treated with TOPAMAX ® should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when TOPAMAX ® is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity. Withdrawal of AEDs Antiepileptic drugs, including TOPAMAX ® , should be withdrawn gradually to minimize the potential of increased seizure frequency. Cognitive/ Neuropsychiatric Adverse Events Adults Text Continues Below
Adverse events 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: 1) psychomotor slowing, difficulty with concentration, and speech or language problems, in particular, word-finding difficulties and 2) somnolence or fatigue. Additional nonspecific CNS effects occasionally observed with topiramate as add-on therapy include dizziness or imbalance, confusion, memory problems, and exacerbation of mood disturbances (e. g., irritability and depression). Reports of psychomotor slowing, speech and language problems, and difficulty with concentration and attention were common in adults. Although in some cases these events were mild to moderate, they at times led to withdrawal from treatment. The incidence of psychomotor slowing is only marginally dose-related, but both language problems and difficulty with concentration or attention clearly increased in frequency with increasing dosage in the five double-blind trials [see ADVERSE REACTIONS, Table 6]. Somnolence and fatigue were the most frequently reported adverse events during clinical trials with TOPAMAX ® . These events were generally mild to moderate and occurred early in therapy. While the incidence of somnolence does not appear to be dose-related, that of fatigue increases at dosages above 400 mg/ day. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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