Safety of carbamazepine extended-release capsules used in combination with other psychotropic medications for the treatment of bipolar I disorder.

Objective: To evaluate the safety and efficacy of carbamazepine extended-release capsules (CBZ-ERC) in combination with other psychotropic medications for the treatment of bipolar I disorder.

Design: In this Phase IIIb, open-label, eight-week, observational, polypharmacy study, adult subjects were started on CBZ-ERC 200mg and titrated over four weeks to optimal dose (1600mg/d maximum). Concomitant lithium and atypical antipsychotics (olanzapine, risperidone, quetiapine, aripiprazole) were permitted.

Efficacy and Safety of Once- versus Twice-Daily Carbamazepine Extended-Release Capsules for the Treatment of Manic Symptoms in Patients with Bipolar I Disorder.

Objective: To compare the efficacy and safety of carbamazepine extended-release capsules (CBZ-ERC) administered twice daily (BID) versus once daily for the treatment of manic symptoms associated with bipolar I disorder in adults.

Design: This was a Phase IIIb, randomized, double-blind, parallel-group, multicenter, 12-week study. Subjects were randomized (1:1) to CBZ-ERC once daily at bedtime (QHS) or BID.

Practical considerations for carbamazepine use in bipolar disorder.

Carbamazepine (CBZ) has a long history of successful use in epilepsy and, therefore, has a safety profile that is well characterised. Additionally, an extended-release formulation of CBZ (CBZ-ERC; Equetro, Shire US) has recently been approved for use in bipolar disorder. The most frequent adverse events associated with CBZ are somnolence, fatigue, dizziness and headache.