Uses
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Seizure Disorders
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Partial Seizures
Oxcarbazepine is used as monotherapy or in combination with other anticonvulsants in the management of partial seizures in adults and children 4 years of age and older.
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Monotherapy
Efficacy of oxcarbazepine monotherapy in patients with partial seizures has been established in several multicenter, randomized, double-blind clinical trials. These studies have included adults and children 8 years of age or older. In one placebo-controlled, randomized clinical trial in patients with refractory partial seizures (undergoing evaluation for epilepsy surgery) who had been withdrawn from anticonvulsants prior to randomization, oxcarbazepine at dosages up to 2400 mg daily for 10 days was more effective than placebo. Results of another placebo-controlled clinical trial in patients with newly diagnosed or recent-onset partial seizures indicate that oxcarbazepine dosages up to 1200 mg daily for 84 days were more effective than placebo. In addition, therapy with oxcarbazepine 2400 mg daily for up to 126 days was substantially more effective than oxcarbazepine 300 mg daily in 2 other clinical trials in patients with partial seizures who had been withdrawn from therapy with 1 or 2 anticonvulsants because of inadequate control.
Results of several multicenter, randomized, double-blind monotherapy trials in patients with newly diagnosed or previously untreated partial or generalized seizures indicate that oxcarbazepine exhibits anticonvulsant activity similar to carbamazepine, phenytoin, or valproate sodium.
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Combination Therapy
Efficacy of oxcarbazepine as adjunctive therapy in patients with partial seizures was established in 2 multicenter, placebo-controlled, randomized, double-blind clinical trials in patients with partial seizures (one in adults and one in children 3-17 years of age). In both studies, patients initially were stabilized with optimum dosages of 1-3 anticonvulsants during an 8-week baseline period; those experiencing at least 8 (minimum 1-4 per month) partial seizures during this phase were randomized to receive oxcarbazepine or placebo during a dosage titration period of 2 weeks followed by a 14- or 24-week maintenance period in children or adults, respectively. Efficacy of oxcarbazepine in these studies was evaluated in terms of the change in seizure frequency (i.e., the median decrease [or increase] in average monthly [28-day] seizure rate). Adult patients receiving oxcarbazepine 600, 1200, or 2400 mg daily or placebo experienced a median decrease in seizure frequency of about 26, 40, 50, or 8%, respectively, while pediatric patients receiving oxcarbazepine maintenance dosages ranging from 30-46 mg/kg daily (depending on baseline body weight) or placebo experienced a median decrease in seizure frequency of about 35 or 9%, respectively.
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Bipolar Disorder
Oxcarbazepine has been used alone or in combination with other drugs (e.g., antipsychotic agents) for the treatment and prevention of acute manic or mixed episodes in patients with bipolar disorder. Limited data suggest that oxcarbazepine may have equivalent efficacy and better tolerability than carbamazepine for this indication. However, the American Psychiatric Association (APA) currently recommends that oxcarbazepine be reserved for patients unable to tolerate or who had an inadequate therapeutic response to first-line agents such as lithium and valproate (e.g., valproic acid, divalproex). For further information on the management of bipolar disorder,