bupropion

bupropion is an FDA-registered drug product whose active ingredient is BUPROPION HYDROCHLORIDE. It is labelled by Proficient Rx LP taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 71205-565, application ANDA202304, label effective 20220401. It is one of 84 FDA drug label records sharing the active ingredient BUPROPION HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BUPROPION HYDROCHLORIDE are most often described in connection with: bupropion hydrochloride, extended-release tablets, treatment major, error hyperlink, depressive disorder, week controlled, mdd defined, statistical manual. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Bupropion Hydrochloride Extended-release (SR) tablets 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 Error! Hyperlink reference not valid. ] . The efficacy of Bupropion Hydrochloride Extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Error! Hyperlink reference not valid. ] . Bupropion Hydrochloride Extended-release (SR) tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( Error! Hyperlink reference not valid. )

2 DOSAGE AND ADMINISTRATION • Starting dose: 150 mg per 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 per day, given as 150 mg twice daily at an interval of at least 8 hours. ( 2.1 ) • Usual target dose: 300 mg per day as 150 mg twice daily. ( 2.1 ) • Maximum dose: 400 mg per day, given as 200 mg twice daily, for patients not responding to 300 mg per 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 (SR) tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion Hydrochloride Extended-release (SR) tablets may be taken with or without food. The usual adult target dose for Bupropion Hydrochloride Extended-release (SR) tablets 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 Bupropion Hydrochloride Extended-release (SR) tablets 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. 2.2 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 Bupropion Hydrochloride Extended-release (SR) tablets 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 (8.7) , Error! Hyperlink reference not valid. ] . 2.3 Dose Adjustment in Patients with Renal Impairment Consider reducing the dose and/or frequency of Bupropion Hydrochloride Extended-release (SR) tablets in patients with renal impairment (Glomerular Filtration Rate less than 90 mL per min) [see Use in Specific Populations (8.6) , Error! Hyperlink reference not valid. ] . 2.4 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 Bupropion Hydrochloride Extended-release (SR) tablets. Conversely, at least 14 days should be allowed after stopping Bupropion Hydrochloride Extended-release (SR) tablets before starting an MAOI antidepressant [see Error! Hyperlink reference not valid. , Drug Interactions (7.6) ] . 2.5 Use of Bupropion Hydrochloride Extended-release (SR) Tablets with Reversible MAOIs Such as Linezolid or Methylene Blue Do not start Bupropion hydrochloride Extended-release (SR) tablets 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 Error! Hyperlink reference not valid. , Drug Interactions (7.6) ] . In some cases, a patient already receiving therapy with Bupropion Hydrochloride Extended-release (SR) tablets 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, Bupropion Hydrochloride Extended-release (SR) tablets 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 Bupropion Hydrochloride Extended-release (SR) tablets 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 per kg with Bupropion Hydrochloride Extended-release (SR) tablets is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see Error! Hyperlink reference not valid. , Drug Interactions (7.6) ] .

4 CONTRAINDICATIONS • Bupropion Hydrochloride Extended-release (SR) tablets are contraindicated in patients with a seizure disorder. • Bupropion Hydrochloride Extended-release (SR) tablets 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 (SR) tablets 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 (SR) tablets or within 14 days of discontinuing treatment with Bupropion Hydrochloride Extended-release (SR) tablets is contraindicated. There is an increased risk of hypertensive reactions when Bupropion Hydrochloride Extended-release (SR) tablets are used concomitantly with MAOIs. The use of Bupropion Hydrochloride Extended-release (SR) tablets within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting Bupropion Hydrochloride Extended-release (SR) tablets in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration (2.4 , 2.5) , Warning and Precautions (5.4) , Drug Interactions (7.6) ]. • Bupropion Hydrochloride Extended-release (SR) tablets are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of Bupropion Hydrochloride Extended-release (SR) tablets. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see Warnings and Precautions (5.8) ] . • Seizure disorder. ( Error! Hyperlink reference not valid. , 5.3 ) • Current or prior diagnosis of bulimia or anorexia nervosa. ( Error! Hyperlink reference not valid. , 5.3 ) • Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( Error! Hyperlink reference not valid. , 5.3 ) • Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with Bupropion Hydrochloride Extended-release (SR) tablets or within 14 days of stopping treatment with Bupropion Hydrochloride Extended-release (SR) tablets. Do not use Bupropion Hydrochloride Extended-release (SR) tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Bupropion Hydrochloride Extended-release (SR) tablets in a patient who is being treated with linezolid or intravenous methylene blue. ( Error! Hyperlink reference not valid. , 7.6 ) • Known hypersensitivity to bupropion or other ingredients of Bupropion Hydrochloride Extended-release (SR) tablets. ( Error! Hyperlink reference not valid. , 5.8 )

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 Error! Hyperlink reference not valid. , Warnings and Precautions (5.1) ] • Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see Error! Hyperlink reference not valid. , 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 Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions Leading to Discontinuation of Treatment: In placebo-controlled clinical trials, 4%, 9%, and 11% of the placebo, 300-mg-per-day, and 400-mg-per-day groups, respectively, discontinued treatment due to adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300-mg-per-day or 400-mg-per-day groups and at a rate at least twice the placebo rate are listed in Table 2. Table 2. Treatment Discontinuations Due to Adverse Reactions in Placebo-Controlled Trials Adverse Reaction Placebo (n=385) Bupropion Hydrochloride Extended-release (SR) tablets 300 mg/day (n=376) Bupropion Hydrochloride Extended-release (SR) tablets 400 mg/day (n=114) Rash 0.0% 2.4% 0.9% Nausea 0.3% 0.8% 1.8% Agitation 0.3% 0.3% 1.8% Migraine 0.3% 0.0% 1.8% Commonly Observed Adverse Reactions: Adverse reactions from Table 3 occurring in at least 5% of subjects treated with Bupropion Hydrochloride Extended-release (SR) tablets and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg-per-day dose groups. Bupropion Hydrochloride Extended-release (SR) tablets 300 mg per day: Anorexia, dry mouth, rash, sweating, tinnitus, and tremor. Bupropion Hydrochloride Extended-release (SR) tablets 400 mg per day: Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Adverse reactions reported in placebo-controlled trials are presented in Table 3. Reported adverse reactions were classified using a COSTART-based Dictionary. Table 3. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical Trials Body System/Adverse Reaction Bupropion Hydrochloride Extended-release (SR) tablets 300 mg/day (n = 376) Bupropion Hydrochloride Extended-release (SR) tablets 400 mg/day (n = 114) Placebo (n = 385) Body (General) Headache 26% 25% 23% Infection 8% 9% 6% Abdominal pain 3% 9% 2% Asthenia 2% 4% 2% Chest pain 3% 4% 1% Pain 2% 3% 2% Fever 1% 2% — Cardiovascular Palpitation 2% 6% 2% Flushing 1% 4% — Migraine 1% 4% 1% Hot flashes 1% 3% 1% Digestive Dry mouth 17% 24% 7% Nausea 13% 18% 8% Constipation 10% 5% 7% Diarrhea 5% 7% 6% Anorexia 5% 3% 2% Vomiting 4% 2% 2% Dysphagia 0% 2% 0% Musculoskeletal Myalgia 2% 6% 3% Arthralgia 1% 4% 1% Arthritis 0% 2% 0% Twitch 1% 2% — Nervous system Insomnia 11% 16% 6% Dizziness 7% 11% 5% Agitation 3% 9% 2% Anxiety 5% 6% 3% Tremor 6% 3% 1% Nervousness 5% 3% 3% Somnolence 2% 3% 2% Irritability 3% 2% 2% Memory decreased — 3% 1% Paresthesia 1% 2% 1% Central nervous system stimulation 2% 1% 1% Respiratory Pharyngitis 3% 11% 2% Sinusitis 3% 1% 2% Increased cough 1% 2% 1% Skin Sweating 6% 5% 2% Rash 5% 4% 1% Pruritus 2% 4% 2% Urticaria 2% 1% 0% Special senses Tinnitus 6% 6% 2% Taste perversion 2% 4% — Blurred vision or diplopia 3% 2% 2% Urogenital Urinary frequency 2% 5% 2% Urinary urgency — 2% 0% Vaginal hemorrhage Incidence based on the number of female subjects. — Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of subjects. 0% 2% — Urinary tract infection 1% 0% — Other Adverse Reactions Observed During the Clinical Development of Bupropion: In addition to the adverse reactions noted above, the following adverse reactions have been reported in clinical trials with the sustained-release formulation of bupropion in depressed subjects and in nondepressed smokers, as well as in clinical trials with the immediate-release formulation of bupropion. Adverse reaction frequencies represent the proportion of subjects who experienced a treatment-emergent adverse reaction on at least one occasion in placebo-controlled trials for depression (n = 987) or smoking cessation (n = 1,013), or subjects who experienced an adverse reaction requiring discontinuation of treatment in an open-label surveillance trial with Bupropion Hydrochloride Extended-release (SR) tablets (n = 3,100). All treatment-emergent adverse reactions are included except those listed in Table 3, those listed in other safety-related sections of the prescribing information, those subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those not reasonably associated with the use of the drug, and those that were not serious and occurred in fewer than 2 subjects. Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse reactions are defined as those occurring in at least 1/100 subjects. Infrequent adverse reactions are those occurring in 1/100 to 1/1,000 subjects, while rare events are those occurring in less than 1/1,000 subjects. Body (General): Infrequent were chills, facial edema, and photosensitivity. Rare was malaise. Cardiovascular: Infrequent were postural hypotension, stroke, tachycardia, and vasodilation. Rare were syncope and myocardial infarction. Digestive: Infrequent were abnormal liver function, bruxism, gastric reflux, gingivitis, increased salivation, jaundice, mouth ulcers, stomatitis, and thirst. Rare was edema of tongue. Hemic and Lymphatic: Infrequent was ecchymosis. Metabolic and Nutritional: Infrequent were edema and peripheral edema. Musculoskeletal: Infrequent were leg cramps. Nervous System: Infrequent were abnormal coordination, decreased libido, depersonalization, dysphoria, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Respiratory: Rare was bronchospasm. Special Senses: Infrequent were accommodation abnormality and dry eye. Urogenital: Infrequent were impotence, polyuria, and prostate disorder. Changes in Body Weight: In placebo-controlled trials, subjects experienced weight gain or weight loss as shown in Table 4. Table 4. Incidence of Weight Gain and Weight Loss (≥5 lbs.) in Placebo-Controlled Trials Weight Change Bupropion Hydrochloride Extended-release (SR) tablets 300 mg/day (n = 339) Bupropion Hydrochloride Extended-release (SR) tablets 400 mg/day (n = 112) Placebo (n = 347) Gained >5 lbs 3% 2% 4% Lost >5 lbs 14% 19% 6% In clinical trials conducted with the immediate-release formulation of bupropion, 35% of subjects receiving tricyclic antidepressants gained weight, compared with 9% of subjects treated with the immediate-release formulation of bupropion. If weight loss is a major presenting sign of a patient’s depressive illness, the anorectic and/or weight-reducing potential of Bupropion Hydrochloride Extended-release (SR) tablets should be considered. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Bupropion Hydrochloride Extended-release (SR) tablets and are not described elsewhere in the label. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body (General): Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness [see Warnings and Precautions (5.8)] . Cardiovascular: Complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe), phlebitis, and pulmonary embolism. Digestive: Colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, pancreatitis, and stomach ulcer. Endocrine: Hyperglycemia, hypoglycemia, hyponatremia, and syndrome of inappropriate antidiuretic hormone secretion. Hemic and Lymphatic: Anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin. Metabolic and Nutritional: Glycosuria. Musculoskeletal: Muscle rigidity/fever/rhabdomyolysis and muscle weakness. Nervous System: Abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, completed suicide, delirium, delusions, dysarthria, euphoria, extrapyramidal syndrome (dyskinesia, dystonia, hypokinesia, parkinsonism), hallucinations, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia. Respiratory: Pneumonia. Skin: Alopecia, angioedema, exfoliative dermatitis, hirsutism, and Stevens-Johnson syndrome. Special Senses: Deafness, increased intraocular pressure, and mydriasis. Urogenital: Abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

FDA lists 84 drug label records with BUPROPION HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is bupropion used for?
1 INDICATIONS AND USAGE Bupropion Hydrochloride Extended-release (SR) tablets 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 …

Who makes bupropion?
Proficient Rx LP is the labeler of record for bupropion. 84 FDA label records share the active ingredient BUPROPION HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does bupropion come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is bupropion prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BUPROPION HYDROCHLORIDE?
Yes. 84 FDA drug label records list BUPROPION HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has bupropion been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.