Budeprion XL
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Budeprion XL
BUDEPRION XL™
(bupropion hydrochloride) Extended-Release Tablets USP (XL)
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of BUDEPRION XL™ [bupropion hydrochloride extended-release tablets (XL)] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. BUDEPRION XL™ is not approved for use in pediatric patients. (See WARNINGS, Clinical Worsening and Suicide Risk, PRECAUTIONS: INFORMATION FOR PATIENTS, and PRECAUTIONS, Pediatric Use.)
DRUG DESCRIPTION
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) , 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 (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:
![BUDEPRION XL [Bupropion hydrochloride] Structural Formula Illustration](http://images.rxlist.com/images/rxlist/budeprionx1.gif) |
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is supplied for oral administration as 150 mg, round white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethyl alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, and hydrogenated vegetable oil. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP drug release testing is pending.
Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Budeprion XL Information
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