FDA Approves Wellbutrin XL(TM) for Major Depressive Disorder Part 3



The efficacy of bupropion inwardly the attention of a foremost depressive phase be unmitigated using the immediate-release formulation in two four-week controlled goings-on of inpatients and one six-week controlled trial of outpatients who come together criterion in back-up of major downturn.

The efficacy of bupropion in carry on an antidepressant retort for competent of 44 weeks was established next to the sustained-release formulation in a placebo-controlled trial. Bupropion have also be shown to be influential in prevent slip back of depression.

In other clinical study, the dutiful part in Wellbutrin XL has proven comparable to Zoloft®* in extravagance pleasant to ascetic homespun major depression.

SAFETY INFORMATION Wellbutrin XL has been proven bioequivalent to both Wellbutrin® Tablets and Wellbutrin SR® tablets. Given that near be multiple formulations of bupropion, confidence with the opposite name and dose outline be essential to stop dosing mistake.

— Journal of Nursing — Journals belong to the American Society of Registered Nurses The American Society of Registered Nurses (ASRN) be found in May 2003 for the occupation of bring jointly administrative nurse interested in generate a nursing “society” which be defined in base camp of “A caravan of human broadly majestic from other group by shared interests, join in distinct dealings, joint institution, and a all-pervading culture”.

Wellbutrin XL is contraindicated in patients who clasp or have have a tremor precariousness, patients person treated with Zyban® (bupropion hydrochloride) Sustained-Release Tablets or Wellbutrin SR® or any other medication that talk huge bupropion, patients who have or had bulimia or anorexia nervosa, patients suffer terse discontinuation of alcohol or dart (including benzodiazepines), and patients taking monoamine oxidase (MAO) inhibitors.

In treating depression, physician should be cognisant that Wellbutrin XL™ is associated with a speculate of seizure which is dose-related.

While Wellbutrin XL has not been publicly contest up to in clinical trials, its evenness of seizure may be the same to that of the immediate-release and the sustained-release formulations of bupropion, since it has demonstrated bioequivalence to both.

At dose of wakeful to 300 mg/day of the sustained-release formulation (Wellbutrin SR®), the incidence of seizure is only about 0.1 percent.

At doses of 300 mg/day to 450 mg/day of the immediate-release (Wellbutrin), the incidence of seizure is approximately 0.4 percent. To culvert the risk of seizures, refer to the Warnings slot of the Prescribing Information for lenient screening consideration, plus concomitant medications and dosing recommendation.

The weight loss upcoming of Wellbutrin XL should be considered if weight loss is a major present gesture of the depressive infection.

When treating patients with severe hepatic cirrhosis, fanatical alertness should be exert and a reduced dosage and/or frequency is essential to avoid collection.

ABOUT GLAXOSMITHKLINE GlaxoSmithKline, one of the world’s main research-based pharmaceutical and healthcare company, is committed to rising the attribute of human days by route of enable individuals to cause more, perceive better-quality and before a live audience longer. GlaxoSmithKline has U.S. operation in Philadelphia and Research Triangle Park, N.C.

For overflowing prescribe numbers or service photo, make happy association Holly Russell at 919-483-2839.

* Zoloft (sertraline HCl) is a survey trademark of Pfizer Inc.

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