May 29, 2017
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Forfivo XL

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Forfivo XL

FORFIVO XL®
(bupropion hydrochloride) Extended-Release Tablets

WARNING

SUICIDAL THOUGHTS AND BEHAVIORS

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older [see WARNINGS AND PRECAUTIONS].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. FORFIVO XL is not approved for use in pediatric patients [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

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 (bupropion hydrochloride extended-release tablets) Structural Formula Illustration

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.

Last reviewed on RxList: 5/19/2017
This monograph has been modified to include the generic and brand name in many instances.

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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