WELLBUTRIN SR 200 mg/1

bupropion hydrochloride · TABLET, FILM COATED · GlaxoSmithKline LLC

No Recall History

Plain English

WELLBUTRIN SR is a tablet, film coated containing bupropion hydrochloride at 200 mg/1, taken oral. Manufactured by GlaxoSmithKline LLC.

Key Facts

Brand Name: WELLBUTRIN SR
Generic Name: bupropion hydrochloride
NDC Code (Product): 0173-0722
Manufacturer: GlaxoSmithKline LLC
Strength: 200 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020358
Marketing Start: 06/25/2002

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective7,594 reports

nausea6,176 reports

fatigue6,016 reports

headache5,601 reports

depression5,274 reports

pain4,589 reports

anxiety4,508 reports

dizziness3,946 reports

off label use3,868 reports

insomnia3,437 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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 ( 14 )] . The efficacy of WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo‑controlled trial [see Clinical Studies ( 14 )] . WELLBUTRIN SR is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Starting dose: 150 mg/day. ( 2.1 ) • General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) • After 3 days, may increase the dose to 300 mg/day, given as 150 mg twice daily at an interval of at least 8 hours. ( 2.1 ) • Usual target dose: 300 mg/day as 150 mg twice daily. ( 2.1 ) • Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients not responding to 300 mg/day. ( 2.1 ) • Periodically reassess the dose and need for maintenance treatment. ( 2.1 ) • Moderate to severe hepatic impairment: 100 mg daily or 150 mg every other day. ( 2.2 , 8.7 ) • Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.2 , 8.7 ) • Renal impairment: Consider reducing the dose and/or frequency. ( 2.3 , 8.6 ) 2.1 General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions ( 5.3 )] . 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/day, given as 150 mg twice daily. Initiate dosing with 150 mg/day given as a single daily dose…

Contraindications

4 CONTRAINDICATIONS • WELLBUTRIN SR is contraindicated in patients with a seizure disorder. • WELLBUTRIN SR is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate‑release formulation of bupropion [see Warnings and Precautions ( 5.3 )]. • WELLBUTRIN SR is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] . • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with WELLBUTRIN SR or within 14 days of discontinuing treatment with WELLBUTRIN SR is contraindicated. There is an increased risk of hypertensive reactions when WELLBUTRIN SR is used concomitantly with MAOIs. The use of WELLBUTRIN SR within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting WELLBUTRIN SR in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.4 , 2.5 ), Warnings and Precautions ( 5.4 ), Drug Interacti…

Drug Interactions

7 DRUG INTERACTIONS • CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical response, but should not exceed the maximum recommended dose. ( 7.1 ) • Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Consider dose reduction when using with bupropion. ( 7.2 ) • Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels. ( 7.2 ) • Drugs that lower seizure threshold: Dose WELLBUTRIN SR with caution. ( 5.3 , 7.3 ) • Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with WELLBUTRIN SR. ( 7.4 ) • MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with WELLBUTRIN SR. ( 7.6 ) • Drug-laboratory test interactions: WELLBUTRIN SR can cause false-positive urine test results f…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning, Warnings and Precautions ( 5.1 )] • Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see Warnings and Precautions ( 5.2 )] • Seizure [see Warnings and Precautions ( 5.3 )] • Hypertension [see Warnings and Precautions ( 5.4 )] • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] • Psychosis and other neuropsychiatric reactions [see Warnings and Precautions ( 5.6 )] • Angle-closure glaucoma [see Warnings and Precautions ( 5.7 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥5% and ≥2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clini…

Frequently Asked Questions

What is WELLBUTRIN SR used for?

WELLBUTRIN SR contains bupropion hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is WELLBUTRIN SR a controlled substance?

WELLBUTRIN SR is not classified as a controlled substance by the DEA.

What is the generic name for WELLBUTRIN SR?

The generic name for WELLBUTRIN SR is bupropion hydrochloride. There are 12 other brand versions of bupropion hydrochloride.

What is the NDC code for WELLBUTRIN SR 200 mg/1?

The NDC (National Drug Code) for WELLBUTRIN SR 200 mg/1 is 0173-0722, listed by GlaxoSmithKline LLC.

Product NDC

0173-0722

Package NDC

0173-0722-00

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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