Forfivo Xl

Forfivo Xl

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Questions & Answers

  • Question

    lillylasam

    I started suffering from Tinnitus exactly 7 days after starting Forgive XL and I am now in my 3rd week without lessening of symptoms. I know that this is one of the side-effects most mentioned. I spoke to my prescribing Psychiatrist and she suggested that I wait another two weeks before making a decision to stop the drug. (1) In the Clinical Trials, did the Tinnitus subside after several weeks on the medication; and (2) Once the medication is discontinued, does the Tinnitus finally stop at some point? I need to know this because the Tinnitus is a real problem for me. Thank you. Phyllis

    posted on February 22, 2016
  • Side Effects & Adverse Reactions

    There is currently no warning information available for this product. We apologize for any inconvenience.

    Legal Issues

    There is currently no legal information available for this drug.

    FDA Safety Alerts

    There are currently no FDA safety alerts available for this drug.

    Manufacturer Warnings

    There is currently no manufacturer warning information available for this drug.

    FDA Labeling Changes

    There are currently no FDA labeling changes available for this drug.

    Uses

    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 (14)].

    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.

    History

    There is currently no drug history available for this drug.

    Other Information

    FORFIVO XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride. The molecular weight is 276.2. The empirical formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white or almost white, crystalline, and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:

    Structural Formula

    FORFIVO XL tablets are supplied for oral administration of 450 mg of bupropion hydrochloride as white to off white extended-release tablets. Each film coated tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: hydroxypropyl cellulose, hydrochloric acid, polyvinyl pyrrolidone and polyvinyl acetate blend, polyethylene oxide, stearic acid, colloidal silicon dioxide, magnesium stearate, hydroxypropylmethyl cellulose, triacetin, talc, methacrylic acid copolymer, polyethylene glycol 8000, titanium dioxide and carboxymethyl cellulose sodium. The logo “Forfivo” is printed on one side of the tablet with edible black ink.

    Forfivo Xl Manufacturers


    • Edgemont Pharmaceuticals, Llc
      Forfivo Xl (Bupropion Hydrochloride) Tablet, Film Coated, Extended Release [Edgemont Pharmaceuticals, Llc]

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