"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complaine"...
Major Depressive Disorder
WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies].
Seasonal Affective Disorder
WELLBUTRIN XL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies].
DOSAGE AND ADMINISTRATION
General Instructions For Use
WELLBUTRIN XL should be swallowed whole and not crushed, divided, or chewed. WELLBUTRIN XL should be administered in the morning and may be taken with or without food.
Dosage For Major Depressive Disorder (MDD)
The recommended starting dose for MDD is 150 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning.
It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode. It is unknown whether the WELLBUTRIN XL dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.
Dosage For Seasonal Affective Disorder (SAD)
The recommended starting dose for SAD is 150 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. Doses above 300 mg of bupropion HCl extended-release were not assessed in the SAD trials.
For the prevention of seasonal MDD episodes associated with SAD, initiate WELLBUTRIN XL in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue WELLBUTRIN XL in early spring. For patients treated with 300 mg per day, decrease the dose to 150 mg once daily before discontinuing WELLBUTRIN XL. Individualize the timing of initiation and duration of treatment should be individualized, based on the patient's historical pattern of seasonal MDD episodes.
Switching Patients From WELLBUTRIN Tablets Or From WELLBUTRIN SR Sustained-Release Tablets
When switching patients from WELLBUTRIN Tablets to WELLBUTRIN XL or from WELLBUTRIN SR Sustained-Release Tablets to WELLBUTRIN XL, give the same total daily dose when possible.
To Discontinue WELLBUTRIN XL, Taper The Dose
When discontinuing treatment in patients treated with WELLBUTRIN XL 300 mg once daily, decrease the dose to 150 mg once daily prior to discontinuation.
Dosage Adjustment In Patients With Hepatic Impairment
In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
Dose Adjustment In Patients With Renal Impairment
Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Antidepressant
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with WELLBUTRIN XL. Conversely, at least 14 days should be allowed after stopping WELLBUTRIN XL before starting an MAOI antidepressant [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Use Of WELLBUTRIN XL With Reversible MAOIs Such As Linezolid Or Methylene Blue
Do not start WELLBUTRIN XL in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].
In some cases, a patient already receiving therapy with WELLBUTRIN XL may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, WELLBUTRIN XL should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with WELLBUTRIN XL may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with WELLBUTRIN XL is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Dosage Forms And Strengths
WELLBUTRIN XL Extended-Release Tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with “WELLBUTRIN XL 150”.
WELLBUTRIN XL Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with “WELLBUTRIN XL 300”.
Storage And Handling
WELLBUTRIN XL® Extended-Release Tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with “WELLBUTRIN XL 150” in bottles of 30 tablets (NDC 0187-0730-30) and 90 tablets (NDC 0187-0730-90).
WELLBUTRIN XL® Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with “WELLBUTRIN XL 300” in bottles of 30 (NDC 0187-0731-30).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86oF) [see USP Controlled Temperature].
WELLBUTRIN XL Tablets may have an odor.
Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA. By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7, Canada. Rev. Dec 2014
Last reviewed on RxList: 1/27/2015
This monograph has been modified to include the generic and brand name in many instances.
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