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FORFIVO XL (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD).
The efficacy in the treatment of MDD was established in two 4-week and one 6-week and one maintenance trial in adult patients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) [see Clinical Studies].
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The efficacy of bupropion in pediatric population has not been established.
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
Instructions For Use
One tablet (450 mg) of FORFIVO XL should be taken once daily without regard to meals. FORFIVO XL tablet should be swallowed whole and not crushed, divided, or chewed.
Initial Treatment With FORFIVO XL
Do not initiate treatment with FORFIVO XL because 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 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 pharmacological therapy beyond response to the acute episode. It is unknown whether or not the 450 mg dose needed to achieve an initial response is identical to the dose needed for maintenance treatment. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Patients With Impaired Hepatic Function
Patients With Impaired Renal Function
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. For: Edgemont Pharmaceuticals, LLC, Austin, TX 78746. Revised January 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/10/2016
Additional Forfivo XL Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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