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FORFIVO XL (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies].
The physician who elects to use FORFIVO XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
DOSAGE AND ADMINISTRATION
General Instructions For Use
One tablet (450 mg) of FORFIVO XL should be taken once daily without regard to meals. FORFIVO XL should be swallowed whole and not crushed, divided, or chewed.
Initial Treatment With FORFIVO XL
Do not initiate treatment with FORFIVO XL because the 450-mg tablet is the only available dose formulation. Use another bupropion formulation for initial dose titration (referring to prescribing information of other bupropion products).
FORFIVO XL can be used in patients who are receiving 300 mg/day of another bupropion formulation for at least 2 weeks, and require a dosage of 450 mg/day.
Patients who are currently being treated with other bupropion products at 450 mg/day can be switched to an equivalent dose of FORFIVO XL once daily.
Maintenance Treatment With FORFIVO XL
It is generally agreed that acute episodes of depression require several months or longer of sustained antidepressant treatment beyond the response in the acute episode. It is unknown whether the 450-mg dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.
To Discontinue FORFIVO XL, Taper The Dose
Because the 450-mg tablet is the only available dose formulation, use another bupropion formulation for tapering the dose prior to discontinuation (referring to prescribing information of other bupropion products).
Patients With Impaired Hepatic Function
Patients With Impaired Renal Function
Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Antidepressant
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with FORFIVO XL. Conversely, at least 14 days should be allowed after stopping FORFIVO XL before starting an MAOI antidepressant [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Use Of FORFIVO XL With Reversible MAOIs Such As Linezolid Or Methylene Blue
Do not start FORFIVO XL in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, nonpharmacological interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].
In some cases, a patient already receiving therapy with FORFIVO XL may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, FORFIVO XL should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with FORFIVO XL may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The risk of administering methylene blue by nonintravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with FORFIVO XL is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Dosage Forms And Strengths
FORFIVO XL Extended-Release Tablets, 450 mg of bupropion hydrochloride, are white to off-white, oval tablets with the logo “Forfivo” printed on one side.
Storage And Handling
FORFIVO XL Extended-Release Tablets, 450 mg of bupropion hydrochloride, are white to off-white, oblong-shaped tablets printed with the “Forfivo” logo on one side supplied in bottles of 30 tablets (NDC 49909-010-30).
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Manufactured by: Pillar5 Pharma, Inc. Arnprior, Ontario, K7S 0C9. Canada. Revised: Aug 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/10/2016
Additional Forfivo XL Information
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