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(bupropion hydrochloride) Tablets
SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
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 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].
Neuropsychiatric Reactions In Patients Taking Bupropion For Smoking Cessation
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see WARNINGS AND PRECAUTIONS]. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although FORFIVO XL is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur [see WARNINGS AND PRECAUTIONS].
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.
Last reviewed on RxList: 11/10/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Forfivo XL Information
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