FDA Approves Bupropion Hydrochloride Extended-Release Tablets (SR) (bupropion) for Major Depressive Disorder

Bupropion Hydrochloride Extended-Release Tablets (SR) are described as an aminoketone antidepressant. The specific mechanism of action is not reported in the label.

Indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy trials were conducted in adult subjects.

Starting dose is 150 mg/day as a single morning dose. After 3 days, the dose may be increased to the usual target dose of 300 mg/day, given as 150 mg twice daily with at least 8 hours between doses. A maximum dose of 400 mg/day, given as 200 mg twice daily, may be considered for patients not responding to 300 mg/day. Doses must not exceed 200 mg in any single dose. Tablets should be swallowed whole, not crushed, divided, or chewed, and may be taken with or without food. For moderate to severe hepatic impairment (Child-Pugh 7-15), maximum dose is 100 mg/day or 150 mg every other day. For mild hepatic impairment (Child-Pugh 5-6) and renal impairment (GFR <90 mL/min), consider reducing dose and/or frequency. When switching to or from an MAOI antidepressant, allow at least 14 days between therapies.

The efficacy of bupropion in treating a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD. The efficacy of this formulation in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial.

The label emphasizes the need to increase the dose gradually to minimize the risk of seizure. It is contraindicated to use with monoamine oxidase inhibitors (MAOIs); at least 14 days must elapse between discontinuing an MAOI and starting bupropion, or vice versa. Do not start bupropion in a patient being treated with a reversible MAOI (e.g., linezolid, intravenous methylene blue). Specific protocols are provided if urgent treatment with linezolid or IV methylene blue is required in a patient already on bupropion.

The label states it is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the initial response. It is unknown whether the dose needed for maintenance is identical to the initial effective dose. Clinicians should periodically reassess the need for maintenance treatment and the appropriate dose.