Topamax Warnings & Precautions

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Topamax - Warnings & Precautions [Topiramate]

Withdrawal of AEDs Antiepileptic drugs, including TOPAMAX Ž , should be withdrawn gradually to minimize the potential of increased seizure frequency.

Cognitive/ Neuropsychiatric Adverse Events Adults

Adverse events most often associated with the use of TOPAMAX Ž 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 Ž . 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.

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.