BUPROPION HYDROCHLORIDE 150 mg/1
BUPROPION HYDROCHLORIDE · TABLET, EXTENDED RELEASE · Preferred Pharmaceuticals Inc.
BUPROPION HYDROCHLORIDE is a tablet, extended release containing bupropion hydrochloride at 150 mg/1, taken oral. Manufactured by Preferred Pharmaceuticals Inc..
Key Facts
- Brand Name
- BUPROPION HYDROCHLORIDE
- Generic Name
- BUPROPION HYDROCHLORIDE
- NDC Code (Product)
68788-7786- Manufacturer
- Preferred Pharmaceuticals Inc.
- Strength
- 150 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210497
- Marketing Start
- 10/21/2020
Recall History
Jubilant Cadista Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Graviti Pharmaceuticals Private Limited
Failed Tablet/Capsule Specifications
Actavis Inc
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Amerisource Health Services LLC
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Actavis Inc
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Sun Pharmaceutical Industries, Inc.
Failed Dissolution Specifications
Sun Pharmaceutical Industries, Inc.
Failed Dissolution Specifications; 18 month stability time point
Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications; 6 month time point
Sun Pharma Global Fze
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Jubilant Cadista Pharmaceuticals, Inc.
Failed Dissolution Specifications; 9-monthstability timepoint
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) (1.1) prevention of seasonal affective disorder (SAD) ( 1.2) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are 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 (14.1) ]. 1.2 Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride e…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Periodically reassess the dose and need for maintenance treatment. ( 2.2 ) Major Depressive Disorder Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily ( 2.2 ) After 4 days, may increase the dose to 300 mg once daily. ( 2.2 ) Seasonal Affective Disorder Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.3 ) Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. ( 2.3 ) After one week, may increase the dose to 300 mg once daily. ( 2.3 ) Continue treatment through the winter season. ( 2.3 ) Hepatic Impairment Moderate to severe hepatic impairment: 150 mg every other day ( 2.6 ) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6 , 8.7 ) Renal Impairment Consider reducing the dose and/or frequency of dosing. ( 2.7 , 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 (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydroch…
Contraindications
4 CONTRAINDICATIONS Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) 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 bupropion hydrochloride extended-release tablets (XL) [see Warnings and Precautions (5.3) ]. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3) ]. The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinu…
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 exposure, 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 ) Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (XL) with caution. ( 5.3 , 7.3 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (XL). ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (XL). ( 7.6 ) Drug-laboratory test interactions: Bupropion hydrochloride extend…
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 children, adolescents, and young adults [see Warnings and Precautions (5.1) ] Neuropsychiatric adverse events 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 events [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 are (incidence ≥5%; ≥2× placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oryza Pharmaceuticals, Inc. at 1-866-637-4281, or FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted und…
Frequently Asked Questions
What is BUPROPION HYDROCHLORIDE used for?
BUPROPION HYDROCHLORIDE contains BUPROPION HYDROCHLORIDE. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is BUPROPION HYDROCHLORIDE a controlled substance?
BUPROPION HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for BUPROPION HYDROCHLORIDE?
The generic name for BUPROPION HYDROCHLORIDE is BUPROPION HYDROCHLORIDE. There are 10 other brand versions of BUPROPION HYDROCHLORIDE.
What is the NDC code for BUPROPION HYDROCHLORIDE 150 mg/1?
The NDC (National Drug Code) for BUPROPION HYDROCHLORIDE 150 mg/1 is 68788-7786, listed by Preferred Pharmaceuticals Inc..
Other BUPROPION HYDROCHLORIDE Dosages
Other Bupropion Brands
See all →- Bupropion Hydrochloride SR150 mg/172162-1529
- Bupropion Hydrochloride300 mg/176420-812
- Bupropion Hydrochloride (XL)300 mg/177771-145
- Bupropion Hydrochloride (XL)150 mg/183008-082
- Bupropion Hydrochloride (XL)300 mg/183301-0025
- Bupropion Hydrochloride XL300 mg/10904-7469
- Bupropion Hydrochloride75 mg/10904-7529
- bupropion hydrochloride150 mg/116571-862
- Bupropion Hydrochloride75 mg/124689-119
- Bupropion Hydrochloride SR150 mg/143598-537
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)