Forfivo Xl
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Questions & Answers
Question
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
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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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:
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.
Sources
Forfivo Xl Manufacturers
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Edgemont Pharmaceuticals, Llc
![Forfivo Xl (Bupropion Hydrochloride) Tablet, Film Coated, Extended Release [Edgemont Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Forfivo Xl | Edgemont Pharmaceuticals, Llc
2.1 Instructions for UseOne 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.
2.2 Initial Treatment with FORFIVO XLDo 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.
2.3 Maintenance Treatment with FORFIVO XLIt 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.
2.4 Patients with Impaired Hepatic FunctionSince there is no lower dose strength for FORFIVO XL, FORFIVO XL is not recommended in patients with hepatic impairment [see Use in Specific Population (8.7) and Clinical Pharmacology (12.3)].
2.5 Patients with Impaired Renal FunctionSince there is no lower dose strength for FORFIVO XL, FORFIVO XL is not recommended in patients with renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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