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WELLBUTRIN SR (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies].
DOSAGE AND ADMINISTRATION
General Instructions For Use
To minimize the risk of seizure, increase the dose gradually [see WARNINGS AND PRECAUTIONS]. WELLBUTRIN SR Tablets should be swallowed whole and not crushed, divided, or chewed. WELLBUTRIN SR may be taken with or without food.
The usual adult target dose for WELLBUTRIN SR is 300 mg per day, given as 150 mg twice daily. Initiate dosing with 150 mg per day given as a single daily dose in the morning. After 3 days of dosing, the dose may be increased to the 300-mg-per-day target dose, given as 150 mg twice daily. There should be an interval of at least 8 hours between successive doses. A maximum of 400 mg per day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg per day. To avoid high peak concentrations of bupropion and/or its metabolites, do not exceed 200 mg in any single dose.
It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of WELLBUTRIN SR 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.
Dose Adjustment In Patients With Hepatic Impairment
In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose of WELLBUTRIN SR is 100 mg per day or 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 SR. Conversely, at least 14 days should be allowed after stopping WELLBUTRIN SR before starting an MAOI antidepressant [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Use Of WELLBUTRIN SR With Reversible MAOIs Such As Linezolid Or Methylene Blue
Do not start WELLBUTRIN SR in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the 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 and DRUG INTERACTIONS].
In some cases, a patient already receiving therapy with WELLBUTRIN SR 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 SR 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 SR 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 SR 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
- 100 mg – blue, round, biconvex, film-coated, sustained-release tablets printed with “WELLBUTRIN SR 100”.
- 150 mg – purple, round, biconvex, film-coated, sustained-release tablets printed with “WELLBUTRIN SR 150”.
- 200 mg – light pink, round, biconvex, film-coated, sustained-release tablets printed with “WELLBUTRIN SR 200”.
Storage And Handling
WELLBUTRIN SR Sustained-Release Tablets, 100 mg of bupropion hydrochloride, are blue, round, biconvex, film-coated tablets printed with “WELLBUTRIN SR 100” in bottles of 60 (NDC 0173-0947-55) tablets.
WELLBUTRIN SR Sustained-Release Tablets, 150 mg of bupropion hydrochloride, are purple, round, biconvex, film-coated tablets printed with “WELLBUTRIN SR 150” in bottles of 60 (NDC 0173-0135-55) tablets.
WELLBUTRIN SR Sustained-Release Tablets, 200 mg of bupropion hydrochloride, are light pink, round, biconvex, film-coated tablets printed with “WELLBUTRIN SR 200” in bottles of 60 (NDC 0173-0722-00) tablets.
Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Manufactured for: GlaxoSmithKline Research Triangle Park, NC 27709
Last reviewed on RxList: 1/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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