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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )

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 Clinical Studies (14)] . 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 Clinical Studies (14)] .

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 )

Bupropion Hydrochloride Extended-release Tablets USP (SR), 100 mg of bupropion hydrochloride, are blue, round, biconvex, film-coated tablets debossed with “S” on one side and “522” on the other. Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg of bupropion hydrochloride, are purple, round, biconvex, film-coated tablets debossed with “S” on one side and “525” on the other. Blistercards of 30 NDC # 0615-8262-39 Bupropion Hydrochloride Extended-release Tablets USP (SR), 200 mg of bupropion hydrochloride, are pink, round, biconvex, film-coated tablets debossed with “S” on one side and “527” on the other. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

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) ] .

Bupropion Hydrochloride Extended-release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO∙HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion Hydrochloride Extended-release Tablets USP (SR) is supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD & C Blue No. 2 Lake, the 150-mg tablet contains FD & C Blue No. 2 Lake and FD & C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. Meet USP Dissolution Test 7.

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 ) Drugs that lower seizure threshold: Dose Bupropion Hydrochloride Extended-release (SR) tablets with caution. ( 5.3 , 7.3 ) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels. ( 7.2) Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with Bupropion Hydrochloride Extended-release (SR) tablets. ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with Bupropion Hydrochloride Extended-release (SR) tablets. ( 7.6 ) Drug-laboratory test interactions: Bupropion Hydrochloride Extended-release (SR) tablets can cause false-positive urine test results for amphetamines. ( 7.7 )

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk Summary Data from published literature report the presence of bupropion and its metabolites in human milk (see Data) . There are no data on the effects of bupropion or its metabolites on milk production. Limited data from postmarketing reports have not identified a clear association of adverse reactions in the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Bupropion Hydrochloride Extended-release (SR) tablets and any potential adverse effects on the breastfed child from Bupropion Hydrochloride Extended-release (SR) tablets or from the underlying maternal condition. Data In a lactation study of 10 women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. The average daily infant exposure (assuming 150 mL/kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose. Postmarketing reports have described seizures in breastfed infants. The relationship of bupropion exposure and these seizures is unclear.

Safety and effectiveness in the pediatric population have not been established [see Boxed Warning, Warnings and Precautions (5.1) ].

Of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged ≥65 years and 47 were aged ≥75 years. In addition, several hundred subjects aged ≥65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see Dosage and Administration (2.3) , Use in Specific Populations (8.6) , Clinical Pharmacology (12.3)] .

Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg/kg/day, respectively. These doses are approximately 7 and 2 times the MRHD, respectively, on a mg/m 2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day (approximately 2 to 7 times the MRHD on a mg/m 2 basis); lower doses were not tested. The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study. Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in the Ames bacterial mutagenicity assay. Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies. There were no effects on male and female fertility when rats were administered oral doses of bupropion up to 300 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis) to females prior to mating and either through Day 13 of gestation or through lactation, and to males for 60 days prior to and through mating. However, doses of 200 mg/kg/day (approximately 5 times the MRHD on a mg/m 2 basis) or greater, caused transient ataxia or behavioral changes in adult female rats. There were also no adverse effects on fertility, reproduction, or growth and development of male or female offspring.

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) ]

Bupropion is not a controlled substance.

The efficacy of the immediate-release formulation of bupropion in the treatment of major depressive disorder was established in two 4-week, placebo-controlled trials in adult inpatients with MDD (Trials 1 and 2 in Table 6) and in one 6-week, placebo-controlled trial in adult outpatients with MDD (Trial 3 in Table 6). In the first trial, the dose range of bupropion was 300 mg to 600 mg/day administered in divided doses; 78% of subjects were treated with doses of 300 mg to 450 mg/day. This trial demonstrated the effectiveness of the immediate-release formulation of bupropion by the Hamilton Depression Rating Scale (HDRS) total score, the HDRS depressed mood item (Item 1), and the Clinical Global Impressions severity score (CGI-S). The second trial included 2 doses of the immediate-release formulation of bupropion (300 and 450 mg/day) and placebo. This trial demonstrated the effectiveness of the immediate-release formulation of bupropion, but only at the 450-mg/day dose. The efficacy results were significant for the HDRS total score and the CGI-S score, but not for HDRS Item 1. In the third trial, outpatients were treated with 300 mg/day of the immediate-release formulation of bupropion. This trial demonstrated the efficacy of the immediate-release formulation of bupropion as measured by the HDRS total score, the HDRS Item 1, the Montgomery-Asberg Depression Rating Scale (MADRS), the CGI-S score, and the CGI-Improvement Scale (CGI-I) score. Table 6. Efficacy of Immediate-Release Bupropion for the Treatment of Major Depressive Disorder n: sample size; SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval included for doses that were demonstrated to be effective; NA: not available. Trial Number Treatment Group Primary Efficacy Measure: HDRS Mean Baseline Score (SD) LS Mean Score at Endpoint Visit (SE) Placebo-subtracted Difference (95% CI) Trial 1 Immediate-Release Bupropion 300-600 mg/day (n = 48) 28.5 (5.1) 14.9 (1.3) -4.7 (-8.8, -0.6) Placebo (n = 27) 29.3 (7.0) 19.6 (1.6) -- Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Difference (95% CI) Trial 2 Immediate-Release Bupropion 300 mg/day (n = 36) 32.4 (5.9) -15.5 (1.7) -4.1 Immediate-Release Bupropion 450 mg/day(n = 34) 34.8 (4.6) -17.4 (1.7) -5.9 (-10.5, -1.4) Placebo (n = 39) 32.9 (5.4) -11.5 (1.6) -- Trial 3 Immediate-Release Bupropion 300 mg/dayb (n = 110) 26.5 (4.3) -12.0 (NA) -3.9 (-5.7, -1.0) Placebo (n = 106) 27.0 (3.5) -8.7 (NA) -- Although there are not as yet independent trials demonstrating the antidepressant effectiveness of the sustained-release formulation of bupropion, trials have demonstrated the bioequivalence of the immediate-release and sustained-release forms of bupropion under steady-state conditions, i.e., bupropion sustained-release 150 mg twice daily was shown to be bioequivalent to 100 mg 3 times daily of the immediate-release formulation of bupropion, with regard to both rate and extent of absorption, for parent drug and metabolites. In a longer-term trial, outpatients meeting DSM-IV criteria for major depressive disorder, recurrent type, who had responded during an 8-week open trial on Bupropion Hydrochloride Extended-release (SR) tablets (150 mg twice daily) were randomized to continuation of their same dose of Bupropion Hydrochloride Extended-release (SR) tablets or placebo for up to 44 weeks of observation for relapse. Response during the open phase was defined as CGI Improvement score of 1 (very much improved) or 2 (much improved) for each of the final 3 weeks. Relapse during the double-blind phase was defined as the investigator’s judgment that drug treatment was needed for worsening depressive symptoms. Patients receiving continued treatment with Bupropion Hydrochloride Extended-release (SR) tablets experienced significantly lower relapse rates over the subsequent 44 weeks compared with those receiving placebo.

Pregnancy Exposure Registry There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-4056185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants . Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data) . There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations). When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 11 times the maximum recommended human dose (MRHD) of 400 mg/day. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately equal to the MRHD and greater. Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data) . The estimated background risk for major birth defects and miscarriage is unknown for the indicated population. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data: Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations. No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database, which had a limited number of exposed cases with cardiovascular malformations, and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) of self-reported bupropion use from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. Study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted OR = 2.6; 95% CI: 1.2, 5.7), and the Slone Epidemiology case control study did not find increased risk for LVOTO. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association. The Slone Epidemiology Study found an increased risk for VSD following first trimester maternal bupropion exposure (n = 17; adjusted OR = 2.5; 95% CI: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including LVOTO as above). The NBDPS and United Healthcare database study did not find an association between first trimester maternal bupropion exposure and VSD. For the findings of LVOTO and VSD, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies. Animal Data: In studies conducted in pregnant rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg/kg/day, respectively (approximately 11 and 7 times the MRHD, respectively, on a mg/m 2 basis). There was no evidence of fetal malformations in rats. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg/kg/day, approximately equal to the MRHD on a mg/m 2 basis) and greater. Decreased fetal weights were observed at doses of 50 mg/kg/day (approximately 2 times the MRHD on a mg/m 2 basis) and greater. No maternal toxicity was evident at doses of 50 mg/kg/day or less. In a pre-and postnatal development study, bupropion administered orally to pregnant rats at doses of up to 150 mg/kg/day (approximately 4 times the MRHD on a mg/m 2 basis) from embryonic implantation through lactation had no effect on pup growth or development.

WARNING:  SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] .

Bupropion Hydrochloride Extended-release (SR) Tablets, USP (bue-PROE-pee-on HYE-droe-KLOR-ide) Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/bupropion-sr-tablets.pdf IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release (SR) Tablets? Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. 2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if Bupropion Hydrochloride Extended-release (SR) tablets are safe and effective in children under the age of 18. Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Talk to your healthcare provider or your family members healthcare provider about: all risks and benefits of quit-smoking medicines all treatment choices for quitting smoking When you try to quit smoking, with or without bupropion you may have symptoms that may be due to nicotine withdrawal, including:  • urge to smoke  • frustration  • restlessness  • depressed mood  • anger  • decreased heart rate  • trouble sleeping  • feeling anxious  • increased appetite  • irritability  • difficulty concentrating  • weight gain Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effect while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions.   Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems. Stop taking Bupropion Hydrochloride Extended-release (SR) tablets and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take Bupropion Hydrochloride Extended-release (SR) tablets. In many people, these symptoms went away after stopping Bupropion Hydrochloride Extended-release (SR) tablets, but in some people, symptoms continued after stopping Bupropion Hydrochloride Extended-release (SR) tablets. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking Bupropion Hydrochloride Extended-release (SR) tablets, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion. What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release (SR) Tablets? Seizures: There is a chance of having a seizure (convulsion, fit) with Bupropion Hydrochloride Extended-release (SR) tablets, especially in people: with certain medical problems. who take certain medicines. The chance of having seizures increases with higher doses of Bupropion Hydrochloride Extended-release (SR) tablets. For more information, see the sections Who should not take Bupropion Hydrochloride Extended-release (SR) tablets? and What should I tell my healthcare provider before taking Bupropion Hydrochloride Extended-release (SR) tablets? Tell your healthcare provider about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are taking Bupropion Hydrochloride Extended-release (SR) tablets unless your healthcare provider has said it is okay to take them. If you have a seizure while taking Bupropion Hydrochloride Extended-release (SR) tablets, stop taking the tablets and call your healthcare provider right away. Do not take Bupropion Hydrochloride Extended-release (SR) tablets again if you have a seizure. High blood pressure (hypertension). Some people get high blood pressure, that can be severe, while taking Bupropion Hydrochloride Extended-release (SR) tablets.  The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking (see the section of this Medication Guide called "How should I take Bupropron Hydrochloride Extended-release (SR) tablets?"). Manic episodes. Some people may have periods of mania while taking Bupropion Hydrochloride Extended-release (SR) tablets, including: Greatly increased energy Severe trouble sleeping Racing thoughts Reckless behavior Unusually grand ideas Excessive happiness or irritability Talking more or faster than usual If you have any of the above symptoms of mania, call your healthcare provider. Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while taking Bupropion hydrochloride, including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider. Visual problems. eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Severe allergic reactions. Some people can have severe allergic reactions to Bupropion Hydrochloride Extended-release (SR) tablets. Stop taking Bupropion Hydrochloride Extended-release (SR) tablets and call your healthcare provider right away  if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. What are Bupropion Hydrochloride Extended-release (SR) tablets? Bupropion Hydrochloride Extended-release (SR) tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder. Who should not take Bupropion Hydrochloride Extended-release (SR) tablets? Do not take Bupropion Hydrochloride Extended-release (SR) tablets if you have or had a seizure disorder or epilepsy. have or had an eating disorder such as anorexia nervosa or bulimia. are taking any other medicines that contain bupropion, ZYBAN ® (used to help people stop smoking), WELLBUTRIN (bupropion hydrochloride tablets), Bupropion hydrochloride extended-release (XL) tablets, APLENZIN, or FORFIVO XL. Bupropion is the same active ingredient that is in Bupropion Hydrochloride Extended-release (SR) tablets. drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden. take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. do not take an MAOI within 2 weeks of stopping Bupropion Hydrochloride Extended-release (SR) tablets unless directed to do so by your healthcare provider. do not start Bupropion Hydrochloride Extended-release (SR) tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. are allergic to the active ingredient in Bupropion Hydrochloride Extended-release (SR) tablets, bupropion, or to any of the inactive ingredients. See the end of this Medication Guide for a complete list of ingredients in Bupropion Hydrochloride Extended-release (SR) tablets. What should I tell my healthcare provider before taking Bupropion Hydrochloride Extended-release (SR) tablets? Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions. Tell your healthcare provider about your other medical conditions including if you: have liver problems, especially cirrhosis of the liver. have kidney problems. have, or have had, an eating disorder, such as anorexia nervosa or bulimia. have had a head injury. have had a seizure (convulsion, fit). have a tumor in your nervous system (brain or spine). have had a heart attack, heart problems, or high blood pressure. are a diabetic taking insulin or other medicines to control your blood sugar. drink alcohol. abuse prescription medicines or street drugs. are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take Bupropion Hydrochloride Extended-release (SR) tablets during pregnancy. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. If you become pregnant during treatment with Bupropion Hydrochloride Extended-release (SR) tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185. are breastfeeding or plan to breastfeed during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. Bupropion Hydrochloride Extended-release (SR) tablets passes into your milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. are breastfeeding. Bupropion hydrochloride passes into your milk in small amounts. Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are taking Bupropion Hydrochloride Extended-release (SR) tablets. How should I take Bupropion Hydrochloride Extended-release (SR) tablets? Take Bupropion Hydrochloride Extended-release (SR) tablets exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Bupropion Hydrochloride Extended-release (SR) tablets without talking to your healthcare provider first. Swallow Bupropion Hydrochloride Extended-release (SR) tablets whole. Do not chew, cut, or crush Bupropion Hydrochloride Extended-release (SR) tablets. If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. Tell your healthcare provider if you cannot swallow tablets. Bupropion Hydrochloride Extended-release (SR) tablets may have an odor. This is normal. Take Bupropion Hydrochloride Extended-release (SR) tablets at the same time each day. Take your doses of Bupropion Hydrochloride Extended-release (SR) tablets at least 8 hours apart. You may take Bupropion Hydrochloride Extended-release (SR) tablets with or without food. If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time. This is very important. Too much Bupropion Hydrochloride Extended-release (SR) tablets can increase your chance of having a seizure. If you take too much Bupropion Hydrochloride Extended-release (SR) tablets, or overdose, call your local emergency room or poison control center right away. Do not take any other medicines while taking Bupropion Hydrochloride Extended-release (SR) tablets unless your healthcare provider has told you it is okay. If you are taking Bupropion Hydrochloride Extended-release (SR) tablets for the treatment of major depressive disorder, it may take several weeks for you to feel that Bupropion Hydrochloride Extended-release (SR) tablets are working. Once you feel better, it is important to keep taking Bupropion Hydrochloride Extended-release (SR) tablets exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel Bupropion Hydrochloride Extended-release (SR) tablets are working for you. What should I avoid while taking Bupropion Hydrochloride Extended-release (SR) tablets? Limit or avoid using alcohol during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures. Do not drive a car or use heavy machinery until you know how Bupropion Hydrochloride Extended-release (SR) tablets affect you. Bupropion Hydrochloride Extended-release (SR) tablets can affect your ability to do these things safely. What are possible side effects of Bupropion Hydrochloride Extended-release (SR) tablets? Bupropion Hydrochloride Extended-release (SR) tablets can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of Bupropion Hydrochloride. The most common side effects of Bupropion Hydrochloride Extended-release (SR) tablets include: Headache Dry mouth Nausea Trouble sleeping Dizziness Sore throat Constipation If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. Tell your healthcare provider right away about any side effects that bother you. These are not all the possible side effects of Bupropion Hydrochloride Extended-release (SR) tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. How should I store Bupropion Hydrochloride Extended-release (SR) tablets Store Bupropion Hydrochloride Extended-release (SR) tablets at room temperature between 68°F and 77°F (20°C to 25°C). Keep Bupropion Hydrochloride Extended-release (SR) tablets dry and out of the light. Keep Bupropion Hydrochloride Extended-release (SR) tablets and all medicines out of the reach of children. General Information about the safe and effective use of Bupropion Hydrochloride Extended-release (SR) Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bupropion Hydrochloride Extended-release (SR) tablets for a condition for which it was not prescribed. Do not give Bupropion Hydrochloride Extended-release (SR) tablets to other people, even if they have the same symptoms you have. It may harm them. If you take a urine drug screening test, Bupropion Hydrochloride Extended-release (SR) tablets may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking Bupropion Hydrochloride Extended-release (SR) tablets, they can do a more specific drug screening test that should not have this problem. This Medication Guide summarizes important information about Bupropion Hydrochloride Extended-release (SR) tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Bupropion Hydrochloride Extended-release (SR) tablets that is written for healthcare professionals. For more information about Bupropion Hydrochloride Extended-release (SR) tablets, call Solco Healthcare US, LLC at 1-866-257-2597. What are the ingredients in Bupropion Hydrochloride Extended-release (SR) tablets? Active ingredient: bupropion hydrochloride. Inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD & C Blue No. 2 Lake, the 150-mg tablet contains FD & C Blue No. 2 Lake and FD & C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and ZYBAN are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks of their respective owners. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 02/2022

100 mg – blue, round, biconvex, film-coated, extended-release (SR) tablets debossed with “S” on one side and “522” on the other. 150 mg – purple, round, biconvex, film-coated, extended-release (SR) tablets debossed with “S” on one side and “525” on the other. 200 mg –pink, round, biconvex, film-coated, extended-release (SR) tablets debossed with “S” on one side and “527” on the other.

The exact mechanism of the antidepressant action of bupropion is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.

Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.

Neuropsychiatric adverse events during smoking cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion for the occurrence of such symptoms and instruct them to discontinue bupropion and contact a healthcare provider if they experience such adverse events. ( 5.2 ) Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if seizure occurs. (4, 5.3 , 7.3 ) Hypertension: Bupropion Hydrochloride Extended-release (SR) tablets can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms. ( 5.5 ) Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 )

PRINCIPAL DISPLAY PANEL

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )

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 Clinical Studies (14)] . 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 Clinical Studies (14)] .

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 )

Bupropion Hydrochloride Extended-release Tablets USP (SR), 100 mg of bupropion hydrochloride, are blue, round, biconvex, film-coated tablets debossed with “S” on one side and “522” on the other. Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg of bupropion hydrochloride, are purple, round, biconvex, film-coated tablets debossed with “S” on one side and “525” on the other. Blistercards of 30 NDC # 0615-8262-39 Bupropion Hydrochloride Extended-release Tablets USP (SR), 200 mg of bupropion hydrochloride, are pink, round, biconvex, film-coated tablets debossed with “S” on one side and “527” on the other. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

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) ] .

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 ) Drugs that lower seizure threshold: Dose Bupropion Hydrochloride Extended-release (SR) tablets with caution. ( 5.3 , 7.3 ) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels. ( 7.2) Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with Bupropion Hydrochloride Extended-release (SR) tablets. ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with Bupropion Hydrochloride Extended-release (SR) tablets. ( 7.6 ) Drug-laboratory test interactions: Bupropion Hydrochloride Extended-release (SR) tablets can cause false-positive urine test results for amphetamines. ( 7.7 )

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk Summary Data from published literature report the presence of bupropion and its metabolites in human milk (see Data) . There are no data on the effects of bupropion or its metabolites on milk production. Limited data from postmarketing reports have not identified a clear association of adverse reactions in the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Bupropion Hydrochloride Extended-release (SR) tablets and any potential adverse effects on the breastfed child from Bupropion Hydrochloride Extended-release (SR) tablets or from the underlying maternal condition. Data In a lactation study of 10 women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. The average daily infant exposure (assuming 150 mL/kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose. Postmarketing reports have described seizures in breastfed infants. The relationship of bupropion exposure and these seizures is unclear.

Safety and effectiveness in the pediatric population have not been established [see Boxed Warning, Warnings and Precautions (5.1) ].

Of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged ≥65 years and 47 were aged ≥75 years. In addition, several hundred subjects aged ≥65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see Dosage and Administration (2.3) , Use in Specific Populations (8.6) , Clinical Pharmacology (12.3)] .

Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg/kg/day, respectively. These doses are approximately 7 and 2 times the MRHD, respectively, on a mg/m 2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day (approximately 2 to 7 times the MRHD on a mg/m 2 basis); lower doses were not tested. The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study. Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in the Ames bacterial mutagenicity assay. Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies. There were no effects on male and female fertility when rats were administered oral doses of bupropion up to 300 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis) to females prior to mating and either through Day 13 of gestation or through lactation, and to males for 60 days prior to and through mating. However, doses of 200 mg/kg/day (approximately 5 times the MRHD on a mg/m 2 basis) or greater, caused transient ataxia or behavioral changes in adult female rats. There were also no adverse effects on fertility, reproduction, or growth and development of male or female offspring.

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) ]

Bupropion is not a controlled substance.

Bupropion Hydrochloride Extended-release Tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO∙HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion Hydrochloride Extended-release Tablets USP (SR) is supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD & C Blue No. 2 Lake, the 150-mg tablet contains FD & C Blue No. 2 Lake and FD & C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. Meet USP Dissolution Test 7.

The efficacy of the immediate-release formulation of bupropion in the treatment of major depressive disorder was established in two 4-week, placebo-controlled trials in adult inpatients with MDD (Trials 1 and 2 in Table 6) and in one 6-week, placebo-controlled trial in adult outpatients with MDD (Trial 3 in Table 6). In the first trial, the dose range of bupropion was 300 mg to 600 mg/day administered in divided doses; 78% of subjects were treated with doses of 300 mg to 450 mg/day. This trial demonstrated the effectiveness of the immediate-release formulation of bupropion by the Hamilton Depression Rating Scale (HDRS) total score, the HDRS depressed mood item (Item 1), and the Clinical Global Impressions severity score (CGI-S). The second trial included 2 doses of the immediate-release formulation of bupropion (300 and 450 mg/day) and placebo. This trial demonstrated the effectiveness of the immediate-release formulation of bupropion, but only at the 450-mg/day dose. The efficacy results were significant for the HDRS total score and the CGI-S score, but not for HDRS Item 1. In the third trial, outpatients were treated with 300 mg/day of the immediate-release formulation of bupropion. This trial demonstrated the efficacy of the immediate-release formulation of bupropion as measured by the HDRS total score, the HDRS Item 1, the Montgomery-Asberg Depression Rating Scale (MADRS), the CGI-S score, and the CGI-Improvement Scale (CGI-I) score. Table 6. Efficacy of Immediate-Release Bupropion for the Treatment of Major Depressive Disorder n: sample size; SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval included for doses that were demonstrated to be effective; NA: not available. Trial Number Treatment Group Primary Efficacy Measure: HDRS Mean Baseline Score (SD) LS Mean Score at Endpoint Visit (SE) Placebo-subtracted Difference (95% CI) Trial 1 Immediate-Release Bupropion 300-600 mg/day (n = 48) 28.5 (5.1) 14.9 (1.3) -4.7 (-8.8, -0.6) Placebo (n = 27) 29.3 (7.0) 19.6 (1.6) -- Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Difference (95% CI) Trial 2 Immediate-Release Bupropion 300 mg/day (n = 36) 32.4 (5.9) -15.5 (1.7) -4.1 Immediate-Release Bupropion 450 mg/day(n = 34) 34.8 (4.6) -17.4 (1.7) -5.9 (-10.5, -1.4) Placebo (n = 39) 32.9 (5.4) -11.5 (1.6) -- Trial 3 Immediate-Release Bupropion 300 mg/dayb (n = 110) 26.5 (4.3) -12.0 (NA) -3.9 (-5.7, -1.0) Placebo (n = 106) 27.0 (3.5) -8.7 (NA) -- Although there are not as yet independent trials demonstrating the antidepressant effectiveness of the sustained-release formulation of bupropion, trials have demonstrated the bioequivalence of the immediate-release and sustained-release forms of bupropion under steady-state conditions, i.e., bupropion sustained-release 150 mg twice daily was shown to be bioequivalent to 100 mg 3 times daily of the immediate-release formulation of bupropion, with regard to both rate and extent of absorption, for parent drug and metabolites. In a longer-term trial, outpatients meeting DSM-IV criteria for major depressive disorder, recurrent type, who had responded during an 8-week open trial on Bupropion Hydrochloride Extended-release (SR) tablets (150 mg twice daily) were randomized to continuation of their same dose of Bupropion Hydrochloride Extended-release (SR) tablets or placebo for up to 44 weeks of observation for relapse. Response during the open phase was defined as CGI Improvement score of 1 (very much improved) or 2 (much improved) for each of the final 3 weeks. Relapse during the double-blind phase was defined as the investigator’s judgment that drug treatment was needed for worsening depressive symptoms. Patients receiving continued treatment with Bupropion Hydrochloride Extended-release (SR) tablets experienced significantly lower relapse rates over the subsequent 44 weeks compared with those receiving placebo.

Pregnancy Exposure Registry There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-4056185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants . Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data) . There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations). When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 11 times the maximum recommended human dose (MRHD) of 400 mg/day. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately equal to the MRHD and greater. Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data) . The estimated background risk for major birth defects and miscarriage is unknown for the indicated population. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data: Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations. No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database, which had a limited number of exposed cases with cardiovascular malformations, and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) of self-reported bupropion use from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. Study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted OR = 2.6; 95% CI: 1.2, 5.7), and the Slone Epidemiology case control study did not find increased risk for LVOTO. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association. The Slone Epidemiology Study found an increased risk for VSD following first trimester maternal bupropion exposure (n = 17; adjusted OR = 2.5; 95% CI: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including LVOTO as above). The NBDPS and United Healthcare database study did not find an association between first trimester maternal bupropion exposure and VSD. For the findings of LVOTO and VSD, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies. Animal Data: In studies conducted in pregnant rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg/kg/day, respectively (approximately 11 and 7 times the MRHD, respectively, on a mg/m 2 basis). There was no evidence of fetal malformations in rats. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg/kg/day, approximately equal to the MRHD on a mg/m 2 basis) and greater. Decreased fetal weights were observed at doses of 50 mg/kg/day (approximately 2 times the MRHD on a mg/m 2 basis) and greater. No maternal toxicity was evident at doses of 50 mg/kg/day or less. In a pre-and postnatal development study, bupropion administered orally to pregnant rats at doses of up to 150 mg/kg/day (approximately 4 times the MRHD on a mg/m 2 basis) from embryonic implantation through lactation had no effect on pup growth or development.

WARNING:  SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] .

Bupropion Hydrochloride Extended-release (SR) Tablets, USP (bue-PROE-pee-on HYE-droe-KLOR-ide) Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/bupropion-sr-tablets.pdf IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release (SR) Tablets? Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. 2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if Bupropion Hydrochloride Extended-release (SR) tablets are safe and effective in children under the age of 18. Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Talk to your healthcare provider or your family members healthcare provider about: all risks and benefits of quit-smoking medicines all treatment choices for quitting smoking When you try to quit smoking, with or without bupropion you may have symptoms that may be due to nicotine withdrawal, including:  • urge to smoke  • frustration  • restlessness  • depressed mood  • anger  • decreased heart rate  • trouble sleeping  • feeling anxious  • increased appetite  • irritability  • difficulty concentrating  • weight gain Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effect while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions.   Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems. Stop taking Bupropion Hydrochloride Extended-release (SR) tablets and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take Bupropion Hydrochloride Extended-release (SR) tablets. In many people, these symptoms went away after stopping Bupropion Hydrochloride Extended-release (SR) tablets, but in some people, symptoms continued after stopping Bupropion Hydrochloride Extended-release (SR) tablets. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking Bupropion Hydrochloride Extended-release (SR) tablets, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion. What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release (SR) Tablets? Seizures: There is a chance of having a seizure (convulsion, fit) with Bupropion Hydrochloride Extended-release (SR) tablets, especially in people: with certain medical problems. who take certain medicines. The chance of having seizures increases with higher doses of Bupropion Hydrochloride Extended-release (SR) tablets. For more information, see the sections Who should not take Bupropion Hydrochloride Extended-release (SR) tablets? and What should I tell my healthcare provider before taking Bupropion Hydrochloride Extended-release (SR) tablets? Tell your healthcare provider about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are taking Bupropion Hydrochloride Extended-release (SR) tablets unless your healthcare provider has said it is okay to take them. If you have a seizure while taking Bupropion Hydrochloride Extended-release (SR) tablets, stop taking the tablets and call your healthcare provider right away. Do not take Bupropion Hydrochloride Extended-release (SR) tablets again if you have a seizure. High blood pressure (hypertension). Some people get high blood pressure, that can be severe, while taking Bupropion Hydrochloride Extended-release (SR) tablets.  The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking (see the section of this Medication Guide called "How should I take Bupropron Hydrochloride Extended-release (SR) tablets?"). Manic episodes. Some people may have periods of mania while taking Bupropion Hydrochloride Extended-release (SR) tablets, including: Greatly increased energy Severe trouble sleeping Racing thoughts Reckless behavior Unusually grand ideas Excessive happiness or irritability Talking more or faster than usual If you have any of the above symptoms of mania, call your healthcare provider. Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while taking Bupropion hydrochloride, including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider. Visual problems. eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Severe allergic reactions. Some people can have severe allergic reactions to Bupropion Hydrochloride Extended-release (SR) tablets. Stop taking Bupropion Hydrochloride Extended-release (SR) tablets and call your healthcare provider right away  if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. What are Bupropion Hydrochloride Extended-release (SR) tablets? Bupropion Hydrochloride Extended-release (SR) tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder. Who should not take Bupropion Hydrochloride Extended-release (SR) tablets? Do not take Bupropion Hydrochloride Extended-release (SR) tablets if you have or had a seizure disorder or epilepsy. have or had an eating disorder such as anorexia nervosa or bulimia. are taking any other medicines that contain bupropion, ZYBAN ® (used to help people stop smoking), WELLBUTRIN (bupropion hydrochloride tablets), Bupropion hydrochloride extended-release (XL) tablets, APLENZIN, or FORFIVO XL. Bupropion is the same active ingredient that is in Bupropion Hydrochloride Extended-release (SR) tablets. drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden. take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. do not take an MAOI within 2 weeks of stopping Bupropion Hydrochloride Extended-release (SR) tablets unless directed to do so by your healthcare provider. do not start Bupropion Hydrochloride Extended-release (SR) tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. are allergic to the active ingredient in Bupropion Hydrochloride Extended-release (SR) tablets, bupropion, or to any of the inactive ingredients. See the end of this Medication Guide for a complete list of ingredients in Bupropion Hydrochloride Extended-release (SR) tablets. What should I tell my healthcare provider before taking Bupropion Hydrochloride Extended-release (SR) tablets? Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions. Tell your healthcare provider about your other medical conditions including if you: have liver problems, especially cirrhosis of the liver. have kidney problems. have, or have had, an eating disorder, such as anorexia nervosa or bulimia. have had a head injury. have had a seizure (convulsion, fit). have a tumor in your nervous system (brain or spine). have had a heart attack, heart problems, or high blood pressure. are a diabetic taking insulin or other medicines to control your blood sugar. drink alcohol. abuse prescription medicines or street drugs. are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take Bupropion Hydrochloride Extended-release (SR) tablets during pregnancy. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. If you become pregnant during treatment with Bupropion Hydrochloride Extended-release (SR) tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185. are breastfeeding or plan to breastfeed during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. Bupropion Hydrochloride Extended-release (SR) tablets passes into your milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. are breastfeeding. Bupropion hydrochloride passes into your milk in small amounts. Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are taking Bupropion Hydrochloride Extended-release (SR) tablets. How should I take Bupropion Hydrochloride Extended-release (SR) tablets? Take Bupropion Hydrochloride Extended-release (SR) tablets exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Bupropion Hydrochloride Extended-release (SR) tablets without talking to your healthcare provider first. Swallow Bupropion Hydrochloride Extended-release (SR) tablets whole. Do not chew, cut, or crush Bupropion Hydrochloride Extended-release (SR) tablets. If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. Tell your healthcare provider if you cannot swallow tablets. Bupropion Hydrochloride Extended-release (SR) tablets may have an odor. This is normal. Take Bupropion Hydrochloride Extended-release (SR) tablets at the same time each day. Take your doses of Bupropion Hydrochloride Extended-release (SR) tablets at least 8 hours apart. You may take Bupropion Hydrochloride Extended-release (SR) tablets with or without food. If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time. This is very important. Too much Bupropion Hydrochloride Extended-release (SR) tablets can increase your chance of having a seizure. If you take too much Bupropion Hydrochloride Extended-release (SR) tablets, or overdose, call your local emergency room or poison control center right away. Do not take any other medicines while taking Bupropion Hydrochloride Extended-release (SR) tablets unless your healthcare provider has told you it is okay. If you are taking Bupropion Hydrochloride Extended-release (SR) tablets for the treatment of major depressive disorder, it may take several weeks for you to feel that Bupropion Hydrochloride Extended-release (SR) tablets are working. Once you feel better, it is important to keep taking Bupropion Hydrochloride Extended-release (SR) tablets exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel Bupropion Hydrochloride Extended-release (SR) tablets are working for you. What should I avoid while taking Bupropion Hydrochloride Extended-release (SR) tablets? Limit or avoid using alcohol during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures. Do not drive a car or use heavy machinery until you know how Bupropion Hydrochloride Extended-release (SR) tablets affect you. Bupropion Hydrochloride Extended-release (SR) tablets can affect your ability to do these things safely. What are possible side effects of Bupropion Hydrochloride Extended-release (SR) tablets? Bupropion Hydrochloride Extended-release (SR) tablets can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of Bupropion Hydrochloride. The most common side effects of Bupropion Hydrochloride Extended-release (SR) tablets include: Headache Dry mouth Nausea Trouble sleeping Dizziness Sore throat Constipation If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. Tell your healthcare provider right away about any side effects that bother you. These are not all the possible side effects of Bupropion Hydrochloride Extended-release (SR) tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. How should I store Bupropion Hydrochloride Extended-release (SR) tablets Store Bupropion Hydrochloride Extended-release (SR) tablets at room temperature between 68°F and 77°F (20°C to 25°C). Keep Bupropion Hydrochloride Extended-release (SR) tablets dry and out of the light. Keep Bupropion Hydrochloride Extended-release (SR) tablets and all medicines out of the reach of children. General Information about the safe and effective use of Bupropion Hydrochloride Extended-release (SR) Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bupropion Hydrochloride Extended-release (SR) tablets for a condition for which it was not prescribed. Do not give Bupropion Hydrochloride Extended-release (SR) tablets to other people, even if they have the same symptoms you have. It may harm them. If you take a urine drug screening test, Bupropion Hydrochloride Extended-release (SR) tablets may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking Bupropion Hydrochloride Extended-release (SR) tablets, they can do a more specific drug screening test that should not have this problem. This Medication Guide summarizes important information about Bupropion Hydrochloride Extended-release (SR) tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Bupropion Hydrochloride Extended-release (SR) tablets that is written for healthcare professionals. For more information about Bupropion Hydrochloride Extended-release (SR) tablets, call Solco Healthcare US, LLC at 1-866-257-2597. What are the ingredients in Bupropion Hydrochloride Extended-release (SR) tablets? Active ingredient: bupropion hydrochloride. Inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD & C Blue No. 2 Lake, the 150-mg tablet contains FD & C Blue No. 2 Lake and FD & C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and ZYBAN are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks of their respective owners. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 02/2022

100 mg – blue, round, biconvex, film-coated, extended-release (SR) tablets debossed with “S” on one side and “522” on the other. 150 mg – purple, round, biconvex, film-coated, extended-release (SR) tablets debossed with “S” on one side and “525” on the other. 200 mg –pink, round, biconvex, film-coated, extended-release (SR) tablets debossed with “S” on one side and “527” on the other.

The exact mechanism of the antidepressant action of bupropion is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.

Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.

Neuropsychiatric adverse events during smoking cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion for the occurrence of such symptoms and instruct them to discontinue bupropion and contact a healthcare provider if they experience such adverse events. ( 5.2 ) Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if seizure occurs. (4, 5.3 , 7.3 ) Hypertension: Bupropion Hydrochloride Extended-release (SR) tablets can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms. ( 5.5 ) Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 )

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