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Wellbutrin Concerns

Aug 7th 2009, 11:53 AM


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In a study comparing 14-day dosing with Wellbutrin Concerns XL Tablets 300 mg once daily to the immediate-release formulation of bupropion at 100 mg 3 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion). Additionally, in a study comparing 14-day dosing with Wellbutrin Concerns XL Tablets 300 mg once daily to the sustained-release formulation of bupropion at 150 mg 2 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites. Absorption: Following oral administration of Wellbutrin Concerns XL Tablets to healthy volunteers, time to peak plasma concentrations for bupropion was approximately 5 hours and food did not affect the In humans, peak plasma concentrations of hydroxybupropion occur approximately 7 hours after administration of Wellbutrin Concerns XL. Following administration of Wellbutrin Concerns XL, peak plasma concentrations of hydroxybupropion are approximately 7 times the peak level of the parent drug at steady state. Although there are no independent trials demonstrating the antidepressant effectiveness of Wellbutrin Concerns XL, studies have demonstrated similar bioavailability of Wellbutrin Concerns XL to both the immediate-release formulation and to the sustained-release formulation of bupropion under steady-state conditions, i.e., Wellbutrin Concerns XL 300 mg once daily was shown to have bioavailability that was similar to that of 100 mg 3 times daily of the immediate-release formulation of bupropion and to that of 150 mg 2 times daily of the sustained-release At the start of the study, patients were randomized to receive placebo or Wellbutrin Concerns XL 150 mg once daily for 1 week, followed by up-titration to 300 mg once daily. Patients who were deemed by the investigator to be unlikely or unable to tolerate 300 mg once daily were allowed to remain on, or had their dose reduced to, 150 mg once daily. The mean Wellbutrin Concerns XL doses in the 3 studies ranged from 257 to 280 mg/day. In these 3 trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for Wellbutrin Concerns XL than for placebo The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Wellbutrin Concerns XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Seasonal Affective Disorder: Wellbutrin Concerns XL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder. CONTRAINDICATIONS Wellbutrin Concerns XL is contraindicated in patients with a seizure disorder. Wellbutrin Concerns XL is contraindicated in patients treated with ZYBAN ® (bupropion hydrochloride) Sustained-Release Tablets; Wellbutrin Concerns ® (bupropion hydrochloride), the immediate-release formulation; Wellbutrin Concerns SR ® (bupropion hydrochloride), the sustained- release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent. Wellbutrin Concerns XL is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion. Wellbutrin Concerns XL is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines). The concurrent administration of Wellbutrin Concerns XL Tablets and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with Wellbutrin Concerns XL Tablets. Wellbutrin Concerns XL is contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up Wellbutrin Concerns XL Tablets.

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