Bupropion hydrochloride

Description

Bupropion hydrochloride extended-release tablets, USP (SR), are chemically distinct from tricyclic, tetracyclic, selective serotonin re-uptake inhibitors, and other known antidepressant agents. The chemical designation is (±)-1-(3-chlorophenyl)-2-(1,1-dimethylethyl)amino-1-propanone hydrochloride, with a molecular weight of 276.2 and a molecular formula of C13H18ClNO HCl. The bupropion hydrochloride powder is characterized as white, crystalline, and highly soluble in water, possessing a bitter taste and inducing a sensation of local anesthesia on the oral mucosa.

These extended-release tablets are formulated for oral administration and are available in strengths of 100 mg (aquamarine), 150 mg (plum), and 200 mg (light pink). Each tablet contains the specified amount of bupropion hydrochloride along with inactive ingredients, which include carnauba wax, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate. The 100 mg tablet is additionally formulated with FD&C blue No. 1 lake, the 150 mg tablet contains FD&C red No. 40 lake and FD&C blue No. 2 lake, and the 200 mg tablet includes FD&C red No. 40 lake and FD&C yellow No. 6 lake.

Uses and Indications

Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD).

There are no teratogenic or nonteratogenic effects associated with the use of this medication.

Dosage and Administration

The recommended starting dose is 150 mg per day. To minimize the risk of seizures, the dose should be increased gradually. After an initial period of 3 days, the dose may be escalated to 300 mg per day, administered as 150 mg twice daily, with an interval of at least 8 hours between doses. The usual target dose is 300 mg per day, maintained as 150 mg twice daily.

For patients who do not respond adequately to the 300 mg per day regimen, the maximum dose may be increased to 400 mg per day, given as 200 mg twice daily. It is essential to periodically reassess the patient's dose and the necessity for ongoing maintenance treatment.

In patients with moderate to severe hepatic impairment, the recommended dosage is 100 mg daily or 150 mg every other day. For those with mild hepatic impairment, consideration should be given to reducing the dose and/or frequency of administration. Similarly, in patients with renal impairment, a reduction in dose and/or frequency may be warranted based on individual patient assessment.

Contraindications

Use of bupropion hydrochloride extended-release tablets (SR) is contraindicated in the following situations:

• Patients with a seizure disorder due to the increased risk of seizures.

• Individuals with a current or prior diagnosis of bulimia or anorexia nervosa, as these conditions may heighten the risk of adverse effects.

• Patients who have abruptly discontinued alcohol, benzodiazepines, barbiturates, or antiepileptic drugs, as this may precipitate seizures.

• Concurrent use with Monoamine Oxidase Inhibitors (MAOIs) intended for psychiatric disorders is contraindicated. Bupropion hydrochloride extended-release tablets (SR) should not be used within 14 days of stopping an MAOI, nor should an MAOI be initiated within 14 days of stopping bupropion hydrochloride extended-release tablets (SR). Additionally, it is contraindicated to start bupropion in patients receiving linezolid or intravenous methylene blue.

• Known hypersensitivity to bupropion or any of the other ingredients in bupropion hydrochloride extended-release tablets (SR).

Warnings and Precautions

The use of bupropion hydrochloride extended-release tablets (SR) necessitates careful consideration of several warnings and precautions to ensure patient safety.

Suicidal Thoughts and Behaviors There is an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Healthcare professionals should closely monitor these patients for any worsening or emergence of suicidal thoughts and behaviors.

Neuropsychiatric Adverse Events During smoking cessation, patients may experience serious or clinically significant neuropsychiatric adverse events. Postmarketing reports have indicated changes in mood, including depression and mania, as well as psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, panic, suicidal ideation, suicide attempts, and completed suicides. It is imperative to observe patients attempting to quit smoking with bupropion for the occurrence of such symptoms. Patients should be instructed to discontinue bupropion and contact a healthcare provider immediately if they experience any of these adverse events.

Seizure Risk The risk of seizures is dose-related. To minimize this risk, healthcare providers should gradually increase the dose and limit the daily dose to a maximum of 400 mg. If a seizure occurs, bupropion should be discontinued.

Hypertension Bupropion hydrochloride extended-release tablets (SR) can elevate blood pressure. Blood pressure should be monitored before initiating treatment and periodically throughout the treatment course.

Bipolar Disorder Screening Patients should be screened for bipolar disorder prior to treatment, and symptoms of mania or hypomania should be monitored throughout the treatment.

Psychosis and Neuropsychiatric Reactions Patients should be advised to contact a healthcare professional if they experience any psychotic symptoms or other neuropsychiatric reactions.

Angle-Closure Glaucoma There is a risk of angle-closure glaucoma in patients with untreated anatomically narrow angles who are treated with antidepressants.

Monitoring Parameters Healthcare professionals are advised to monitor blood pressure before and periodically during treatment to manage the risk of hypertension effectively. Additionally, screening for bipolar disorder and monitoring for symptoms of mania or hypomania are essential components of patient management.

Emergency Instructions Patients should be instructed to seek emergency medical help if they experience psychosis or other neuropsychiatric reactions. Furthermore, they should discontinue bupropion and contact a healthcare provider if they experience any neuropsychiatric adverse events during smoking cessation or if a seizure occurs.

Side Effects

Patients receiving bupropion hydrochloride extended-release tablets (SR) may experience a range of adverse reactions. The most common adverse reactions reported include headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitations, myalgia, sweating, rash, and anorexia.

Serious adverse reactions warranting caution include an increased risk of suicidal thoughts and behaviors, particularly in children, adolescents, and young adults taking antidepressants. Patients should be closely monitored for the emergence or worsening of suicidal ideation and behaviors.

Neuropsychiatric adverse events have also been observed, including changes in mood (such as depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, panic, suicidal ideation, suicide attempts, and completed suicides. Patients should be instructed to contact a healthcare professional if they experience any of these reactions.

The risk of seizures is dose-related; therefore, it is recommended to gradually increase the dose and limit the daily dose to 400 mg. Discontinuation of the medication is advised if a seizure occurs. Additionally, bupropion can increase blood pressure, necessitating monitoring before and during treatment.

Activation of mania or hypomania has been reported, highlighting the importance of screening patients for bipolar disorder and monitoring for these symptoms. Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles who are treated with antidepressants.

Patients with a seizure disorder, current or prior diagnosis of bulimia or anorexia nervosa, or those who have abruptly discontinued alcohol, benzodiazepines, barbiturates, or antiepileptic drugs should exercise caution. The use of monoamine oxidase inhibitors (MAOIs) in conjunction with bupropion is contraindicated, as is the use of bupropion within 14 days of stopping an MAOI intended for psychiatric disorders.

In cases of overdose, seizures were reported in approximately one-third of all instances. Other serious reactions associated with bupropion overdose include hallucinations, loss of consciousness, mental status changes, sinus tachycardia, ECG changes (including conduction disturbances and arrhythmias), clonus, myoclonus, hyperreflexia, fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure. Deaths have been reported in patients who ingested large doses of bupropion, often preceded by multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest.

Drug Interactions

Coadministration of bupropion hydrochloride extended-release tablets (SR) with certain drug classes may lead to significant interactions that require careful consideration.

CYP2B6 Inducers When bupropion is administered alongside CYP2B6 inducers such as ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin, an increase in bupropion dosage may be necessary based on clinical response. However, the dosage should not exceed the maximum recommended limit.

CYP2D6 Substrates Bupropion is a known inhibitor of CYP2D6, which can lead to elevated plasma concentrations of drugs metabolized by this enzyme, including certain antidepressants, antipsychotics, beta-blockers, and Type 1C antiarrhythmics. A dose reduction of these medications should be considered when used concurrently with bupropion.

Digoxin Bupropion may reduce plasma levels of digoxin. It is advisable to monitor digoxin levels closely in patients receiving both medications to ensure therapeutic efficacy.

Drugs Lowering Seizure Threshold Caution is advised when prescribing bupropion hydrochloride extended-release tablets (SR) in conjunction with drugs that lower the seizure threshold, as this may increase the risk of seizures.

Dopaminergic Drugs Concomitant use of bupropion with dopaminergic agents such as levodopa and amantadine may result in central nervous system (CNS) toxicity. Monitoring for signs of CNS effects is recommended.

Monoamine Oxidase Inhibitors (MAOIs) The combination of bupropion hydrochloride extended-release tablets (SR) with MAOIs can heighten the risk of hypertensive reactions. Caution is warranted, and close monitoring is advised.

Drug-Laboratory Test Interactions Bupropion hydrochloride extended-release tablets (SR) may cause false-positive results in urine tests for amphetamines. This potential interaction should be communicated to healthcare providers conducting such tests.

Packaging & NDC

The table below lists all NDC Code configurations of Bupropion Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. Healthcare professionals should refer to the Boxed Warning and Warnings and Precautions (5.1) for further information regarding the use of this medication in children and adolescents. Caution is advised when considering treatment options for pediatric patients.

Geriatric Use

Clinical trials involving bupropion sustained-release tablets included approximately 6,000 subjects, of which 275 were aged 65 years and older, and 47 were aged 75 years and older. Additionally, several hundred subjects aged 65 years and older participated in clinical trials utilizing the immediate-release formulation of bupropion for depression.

No overall differences in safety or effectiveness were observed between elderly patients and younger subjects. However, while clinical experience has not identified significant differences in responses, it is important to note that greater sensitivity to the drug may be present in some older individuals.

Bupropion is extensively metabolized in the liver to active metabolites, which are subsequently metabolized and excreted by the kidneys. Given that elderly patients are more likely to have decreased renal function, the risk of adverse reactions may be heightened in this population. Therefore, it is advisable to consider renal function when selecting a dose for geriatric patients, and monitoring of renal function may be beneficial to ensure safety and efficacy.

Pregnancy

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 1-844-405-6185 or visiting online at National Pregnancy Registry for AntidepressantsNational Pregnancy Registry for Antidepressants.

Risk summary data from epidemiological studies indicate that pregnant women exposed to bupropion during the first trimester have not shown an increased risk of congenital malformations overall. However, untreated depression during pregnancy poses risks to the mother. Animal studies have demonstrated that 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. Conversely, in pregnant rabbits, non-dose-related increases in the incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the MRHD and greater, with decreased fetal weights noted at doses twice the MRHD and higher.

The estimated background risk for major birth defects and miscarriage in the indicated population remains unknown. All pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical considerations from a prospective, longitudinal study involving 201 pregnant women with a history of major depressive disorder indicate that those who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression compared to those who continued treatment. Therefore, healthcare providers should weigh the risks of untreated depression against the potential effects on the fetus when considering discontinuation or modification of antidepressant therapy during pregnancy and postpartum.

Human data from the international bupropion Pregnancy Registry, which included 675 first trimester exposures, and a retrospective cohort study using the United Healthcare database with 1,213 first trimester exposures, did not demonstrate an overall increased risk for malformations. However, the registry was not specifically designed to evaluate individual defects but suggested a possible increase in cardiac malformations. Notably, no increased risk for cardiovascular malformations overall has been observed following bupropion exposure during the first trimester, with a prospectively observed rate of 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which aligns with the background rate of approximately 1%.

Findings regarding the association between bupropion exposure during the first trimester and left ventricular outflow tract obstruction (LVOTO) are inconsistent, preventing definitive conclusions. The United Healthcare database lacked sufficient power to evaluate this association, while the National Birth Defects Prevention Study (NBDPS) indicated an increased risk for LVOTO (n=10; adjusted OR=2.6; 95% CI: 1.2, 5.7). In contrast, the Slone Epidemiology case-control study did not find an increased risk for LVOTO. Similarly, findings related to ventricular septal defect (VSD) are inconsistent, with the Slone Epidemiology Study reporting an increased risk for VSD following first trimester maternal bupropion exposure (n=17; adjusted OR=2.5; 95% CI: 1.3, 5.0), while the NBDPS and United Healthcare database studies did not find an association. Limitations in these studies include small sample sizes, inconsistent findings, and the potential for chance findings due to multiple comparisons.

Animal studies have shown that bupropion administered orally to pregnant rats and rabbits during organogenesis at doses of up to 450 and 150 mg/kg/day, respectively (approximately 11 and 7 times the MRHD on a mg/m² basis), did not result in fetal malformations in rats. However, in rabbits, non-dose-related increases in fetal malformations and skeletal variations were observed at the lowest tested dose (25 mg/kg/day, approximately equal to the MRHD on a mg/m² basis) and higher. Decreased fetal weights were noted at doses of 50 mg/kg/day (approximately 2 times the MRHD on a mg/m² basis) and greater, with no maternal toxicity evident at doses of 50 mg/kg/day or less. In a pre- and postnatal development study, bupropion administered to pregnant rats at doses of up to 150 mg/kg/day (approximately 4 times the MRHD on a mg/m² basis) from embryonic implantation through lactation did not affect pup growth or development.

Lactation

Data from published literature report the presence of bupropion and its metabolites in human milk. In a lactation study involving 10 women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. The average daily infant exposure, assuming a daily consumption of 150 mL/kg, to bupropion and its active metabolites was found to be 2% of the maternal weight-adjusted dose.

There are no data available regarding 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 breastfed infants. However, it is important to note that postmarketing reports have described seizures in breastfed infants, although the relationship between bupropion exposure and these seizures remains unclear.

The developmental and health benefits of breastfeeding should be considered alongside the mother’s clinical need for bupropion hydrochloride extended-release tablets (SR) and any potential adverse effects on the breastfed child from the medication or from the underlying maternal condition.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In cases of bupropion overdose, significant clinical manifestations can occur, necessitating immediate medical intervention. Reports indicate that overdoses of 30 grams or more have been documented, with seizures occurring in approximately one-third of these instances.

Clinical Manifestations

Serious adverse reactions associated with bupropion overdose may include hallucinations, loss of consciousness, alterations in mental status, and respiratory failure. These symptoms are particularly pronounced in cases involving multiple drug overdoses. Furthermore, fatalities linked to bupropion overdose have been observed, often following a sequence of multiple uncontrolled seizures, bradycardia, cardiac failure, and ultimately cardiac arrest.

Management and Supportive Care

There are currently no known antidotes for bupropion; therefore, supportive care and vigilant medical supervision are critical in managing overdose cases. Healthcare professionals should ensure that the patient has an adequate airway, oxygenation, and ventilation. Continuous monitoring of cardiac rhythm and vital signs is essential throughout the management process.

Induction of emesis is not recommended in the event of a bupropion overdose due to the potential for further complications. In all cases of suspected overdose, it is imperative to consult a Certified Poison Control Center for expert guidance. Healthcare providers can reach the Poison Control Center by calling 1-800-222-1222 or visiting www.poison.org.

Nonclinical Toxicology

No teratogenic effects were observed in the studies conducted. In terms of non-teratogenic effects, administration of oral doses of bupropion up to 300 mg/kg/day to female rats prior to mating and continuing through Day 13 of gestation or lactation, as well as to male rats for 60 days prior to and during mating, did not result in any adverse effects on male and female fertility. However, doses of 200 mg/kg/day or greater caused transient ataxia or behavioral changes in adult female rats. Additionally, there were no adverse effects noted on fertility, reproduction, or the growth and development of male or female offspring.

Lifetime carcinogenicity studies were conducted in rats and mice with bupropion doses of up to 300 mg/kg/day and 150 mg/kg/day, respectively. These doses correspond to approximately 7 and 2 times the maximum recommended human dose (MRHD) on a mg/m² basis. In the rat study, an increase in nodular proliferative lesions of the liver was observed at doses ranging from 100 to 300 mg/kg/day, which is approximately 2 to 7 times the MRHD on a mg/m² basis; lower doses were not evaluated. The potential for these lesions to serve as precursors to liver neoplasms remains unresolved. In contrast, similar liver lesions were not detected in the mouse study, and no increase in malignant tumors of the liver or other organs was observed in either study.

Bupropion demonstrated a positive response in the Ames bacterial mutagenicity assay, with a mutation rate 2 to 3 times higher than the control in 2 of 5 strains tested. Furthermore, an increase in chromosomal aberrations was noted in 1 of 3 in vivo rat bone marrow cytogenetic studies.

Postmarketing Experience

Some patients have reported experiencing changes in mood, including depression and mania, as well as psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic. Additionally, suicidal ideation and suicide attempts have been noted in individuals attempting to quit smoking while taking bupropion.

Reports indicate that new or exacerbated mental health issues, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions, have occurred in some individuals using bupropion for smoking cessation. Unusual thoughts or behaviors, including delusions, hallucinations, paranoia, or confusion, have also been documented among patients taking bupropion hydrochloride extended-release tablets (SR).

Severe allergic reactions to bupropion hydrochloride extended-release tablets (SR) have been reported, with symptoms including 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 difficulty breathing.

The incidence of seizures appears to increase with higher doses of bupropion hydrochloride extended-release tablets (SR). Some patients have experienced elevated blood pressure, which can be severe, particularly when bupropion is used in conjunction with nicotine replacement therapy.

Periods of mania have been reported in some individuals taking bupropion hydrochloride extended-release tablets (SR). Visual disturbances, including eye pain, changes in vision, and swelling or redness in or around the eye, have also been noted.

Patient Counseling

Healthcare providers should advise patients to read the FDA-approved patient labeling, specifically the Medication Guide, to ensure they understand the medication's use and potential risks. It is important to instruct patients, their families, and caregivers to be vigilant for the emergence of symptoms such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, and other unusual behavioral changes, as well as worsening depression and suicidal ideation, particularly during the initial stages of antidepressant treatment and when dosage adjustments are made.

Families and caregivers should be encouraged to monitor patients closely for these symptoms on a daily basis, as changes can occur abruptly. Any severe or sudden onset of these symptoms, especially if they were not part of the patient's initial presentation, should be reported to the prescriber or healthcare professional promptly.

Patients should be informed that some individuals may experience mood changes, including depression and mania, as well as psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, panic, and suicidal thoughts when attempting to quit smoking while taking bupropion. They should be instructed to discontinue bupropion and contact a healthcare professional if they experience any of these symptoms.

Education on hypersensitivity symptoms is essential, and patients should be advised to discontinue bupropion hydrochloride extended-release tablets (SR) if they experience a severe allergic reaction. Additionally, patients must be instructed to stop taking the medication and not to restart it if they experience a seizure during treatment.

Healthcare providers should inform patients that excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizures, and patients should be advised to minimize or avoid alcohol consumption. During the initial titration phase, particularly when increasing the dose above 150 mg/day, patients should take bupropion hydrochloride extended-release tablets (SR) in two divided doses, with at least 8 hours between doses, to reduce the risk of seizures.

Patients should be made aware that bupropion hydrochloride extended-release tablets (SR) can cause mild pupillary dilation, which may lead to angle-closure glaucoma in susceptible individuals. It is also important to inform patients that bupropion hydrochloride extended-release tablets (SR) contain the same active ingredient as ZYBAN®, which is used for smoking cessation, and should not be used in conjunction with ZYBAN® or any other bupropion-containing medications.

Patients should be counseled that any CNS-active drug, including bupropion hydrochloride extended-release tablets (SR), may impair their ability to perform tasks that require judgment or motor and cognitive skills. They should notify their healthcare provider if they are taking or plan to take any prescription or over-the-counter medications, as interactions may affect drug metabolism.

Patients should also inform their healthcare provider if they become pregnant or plan to become pregnant while on bupropion hydrochloride extended-release tablets (SR). Proper storage instructions should be provided, advising patients to keep the tablets at room temperature, between 68°F and 77°F (20°C to 25°C), and to protect them from moisture and light.

Patients must be instructed to swallow bupropion hydrochloride extended-release tablets (SR) whole, without chewing, dividing, or crushing them, to maintain the intended release rate. If a dose is missed, patients should not take an extra tablet to compensate but should take the next dose at the regular scheduled time due to the dose-related risk of seizure. Patients should be informed that bupropion hydrochloride extended-release tablets (SR) may have an odor and can be taken with or without food.

Storage and Handling

The product is supplied in a tight, light-resistant container that meets the specifications outlined in the United States Pharmacopeia (USP) and includes a child-resistant closure as required.

It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. The product must be protected from light and moisture, and the container should remain tightly closed to maintain integrity.

Additional Clinical Information

Patients receiving bupropion hydrochloride extended-release tablets for major depressive disorder (MDD) or other indications should be closely monitored by families and caregivers for signs of agitation, irritability, unusual behavioral changes, and suicidality. It is crucial for caregivers to report any concerning symptoms to healthcare providers immediately. Patients and their caregivers should be advised to discontinue the medication and seek medical attention if they observe any atypical changes in mood or behavior, including suicidal thoughts or actions. Additionally, patients should contact a healthcare professional if they experience neuropsychiatric symptoms such as delusions, hallucinations, or confusion, or if they develop any allergic reactions during treatment.

Postmarketing experience has revealed serious neuropsychiatric adverse events associated with bupropion, particularly in patients using it for smoking cessation. These events include mood changes, psychosis, and suicidal ideation, among others. While some patients may experience symptoms of nicotine withdrawal, which can include depression, it is important to note that adverse events have also occurred in patients who continued to smoke while on bupropion. In many cases, symptoms resolved after discontinuation of the medication; however, persistent symptoms have been reported, necessitating ongoing monitoring and supportive care until resolution.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Bupropion Hydrochloride as submitted by Epic Pharma LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)