Drugplain

Bupropion Hydrochloride SR 150 mg/1

bupropion hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Bryant Ranch Prepack

No Recall History
Plain English

Bupropion Hydrochloride SR is a tablet, film coated, extended release containing bupropion hydrochloride at 150 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Bupropion Hydrochloride SR
Generic Name
bupropion hydrochloride
NDC Code (Product)
72162-1529
Manufacturer
Bryant Ranch Prepack
Strength
150 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA205794
Marketing Start
04/20/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,893 reports
headache1,386 reports
depression1,322 reports
fatigue1,292 reports
nausea1,108 reports
off label use990 reports
pain907 reports
drug interaction853 reports
anxiety846 reports
rash784 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Bupropion Hydrochloride Extended-Release Tablets (SR) are 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 Bupropion Hydrochloride Extended-Release Tablets (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 )] . Bupropion Hydrochloride Extended-Release Tablets (SR) are 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 )] . Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (SR) may be taken with or without food. The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/d…

Contraindications

4 CONTRAINDICATIONS Bupropion Hydrochloride Extended-Release Tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion Hydrochloride Extended-Release Tablets (SR) are 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 )] . Bupropion Hydrochloride Extended-Release Tablets (SR) are 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 Bupropion Hydrochloride Extended-Release Tablets (SR) or within 14 days of discontinuing treatment with Bupropion Hydrochloride Extended-Release Tablets (SR) is contraindicated. There is an increased risk of hypertensive reactions when Bupropion Hydrochloride Extended-Release Tablets (SR) are used concomitantly with MAOIs. The use of Bupropion Hydrochloride Extended-Release Tablets (SR) within 14 days of discontinuin…

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 bupropion hydrochloride extended-release tablets (SR) with caution. ( 5.3 , 7.3 ) Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR). ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (S…

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 Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinica…

Frequently Asked Questions

What is Bupropion Hydrochloride SR used for?

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

Is Bupropion Hydrochloride SR a controlled substance?

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

What is the generic name for Bupropion Hydrochloride SR?

The generic name for Bupropion Hydrochloride SR is bupropion hydrochloride. There are 10 other brand versions of bupropion hydrochloride.

What is the NDC code for Bupropion Hydrochloride SR 150 mg/1?

The NDC (National Drug Code) for Bupropion Hydrochloride SR 150 mg/1 is 72162-1529, listed by Bryant Ranch Prepack.

Product NDC

72162-1529

Package NDC

72162-1529-5

Other Bupropion Hydrochloride SR Dosages

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

Data from openFDA · Public domain (CC0 1.0)