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Generic Name
BuPROPion
Brand Names
Aplenzin, Auvelity, Forfivo, Wellbutrin
FDA approval date: November 15, 1996
Classification: Aminoketone
Form: Tablet, Kit
What is Aplenzin (BuPROPion)?
APLENZIN is an aminoketone antidepressant, indicated for the treatment of major depressive disorder and seasonal affective disorder . Periodically reevaluate long-term usefulness for the individual patient.
Approved To Treat
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Brand Information
Aplenzin (bupropion hydrobromide)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
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 aged 65 and older 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
1DOSAGE FORMS AND STRENGTHS
APLENZIN Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “174”.
APLENZIN Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “348”.
APLENZIN Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “522”.
2CONTRAINDICATIONS
- APLENZIN is contraindicated in patients with a seizure disorder.
- APLENZIN is 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 APLENZIN
- APLENZIN is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
- The use of MAOIs (intended to treat psychiatric disorders) concomitantly with APLENZIN or within 14 days of discontinuing treatment with APLENZIN is contraindicated. There is an increased risk of hypertensive reactions when APLENZIN is used concomitantly with MAOIs. The use of APLENZIN within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting APLENZIN in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated
- APLENZIN is contraindicated in patients with known hypersensitivity to bupropion or other ingredients of APLENZIN. Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Suicidal thoughts and behaviors in children, adolescents, and young adults
- Neuropsychiatric adverse events and suicide risk in smoking cessation treatment
- Seizure
- Hypertension
- Activation of mania or hypomania
- Psychosis and other neuropsychiatric events
- Angle-closure glaucoma
- Hypersensitivity reactions
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.1.1Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-Release Bupropion Hydrochloride
Adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.
300 mg/day of bupropion HCl sustained-release (equivalent to APLENZIN 348 mg/day): anorexia, dry mouth, rash, sweating, tinnitus, and tremor.
400 mg/day of bupropion HCl sustained-release (equivalent to APLENZIN 464 mg/day): abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.
APLENZIN is bioequivalent to bupropion HCl extended-release, which has been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion. The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride.
Major Depressive Disorder
Adverse Reactions Leading to Discontinuation of Treatment with Bupropion HCl Immediate-Release, Bupropion HCl Sustained-Release, and Bupropion HCl Extended-Release in Major Depressive Disorder Trials
In placebo-controlled clinical trials with bupropion HCl sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300 mg/day or 400 mg/day groups and at a rate at least twice the placebo rate are listed in
In clinical trials with bupropion HCl immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction. Reactions resulting in discontinuation (in addition to those listed above for the sustained-release formulation) included vomiting, seizures, and sleep disturbances.
Adverse Reactions Occurring at an Incidence of >1% in Patients Treated with Bupropion HCl Immediate-Release or Bupropion HCl Sustained-Release in MDD
Table 4 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion HCl sustained-release 300 mg/day and 400 mg/day. These include reactions that occurred in either the 300 mg or 400 mg group at an incidence of 1% or more and were more frequent than in the placebo group.
The following additional adverse reactions occurred in controlled trials of bupropion HCl immediate-release (300 to 600 mg per day) at an incidence of at least 1% more frequently than in the placebo group were: cardiac arrhythmia (5% vs. 4%), hypertension (4% vs. 2%), hypotension (3% vs. 2%), tachycardia (11% vs. 9%), appetite increased (4% vs. 2%), dyspepsia (3% vs. 2%), menstrual complaints (5% vs. 1%), akathisia (2% vs. 1%), impaired sleep quality (4% vs. 2%), sensory disturbance (4% vs. 3%), confusion (8% vs. 5%), decreased libido (3% vs. 2%), hostility (6% vs. 4%), auditory disturbance (5% vs. 3%), and gustatory disturbance (3% vs. 1%).
Seasonal Affective Disorder
In placebo-controlled clinical trials in SAD, 9% of patients treated with bupropion HCl extended-release and 5% of patients treated with placebo discontinued treatment because of adverse reactions. The adverse reactions leading to discontinuation in at least 1% of patients treated with bupropion and at a rate numerically greater than the placebo rate were insomnia (2% vs. <1%) and headache (1% vs. <1%).
Table 5 summarizes the adverse reactions that occurred in patients treated with bupropion HCl extended-release for up to approximately 6 months in 3 placebo-controlled trials. These include reactions that occurred at an incidence of 2% or more and were more frequent than in the placebo group.
Changes in Body Weight
Table 6 presents the incidence of body weight changes (≥5 lbs) in the short-term MDD trials using bupropion HCl sustained-release. There was a dose-related decrease in body weight.
Table 7 presents the incidence of body weight changes (≥5 lbs) in the 3 SAD trials using bupropion HCl extended-release. A higher proportion of subjects in the bupropion group (23%) had a weight loss ≥5 lbs, compared to the placebo group (11%). These were relatively long-term trials (up to 6 months).
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of APLENZIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body (General)
Chills, facial edema, edema, peripheral edema, musculoskeletal chest pain, photosensitivity, and malaise.
Cardiovascular
Postural hypotension, stroke, vasodilation, syncope, complete atrioventricular block, extrasystoles, myocardial infarction, phlebitis, pulmonary embolism, and Brugada pattern/syndrome.
Digestive
Abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, thirst, edema of tongue, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.
Endocrine
Hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone secretion.
Hemic and Lymphatic
Ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.
Metabolic and Nutritional
Glycosuria.
Musculoskeletal
Leg cramps, fever/rhabdomyolysis, and muscle weakness.
Nervous System
Abnormal coordination, depersonalization, emotional lability, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, derealization, abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, unmasking tardive dyskinesia and aseptic meningitis.
Respiratory
Bronchospasm and pneumonia.
Skin and Subcutaneous Tissue Disorders
Maculopapular rash, alopecia, angioedema, exfoliative dermatitis, hirsutism, acute generalized exanthematous pustulosis and drug reaction with eosinophilia and systemic symptoms (DRESS).
Special Senses
Accommodation abnormality, dry eye, deafness, increased intraocular pressure, angle-closure glaucoma, and mydriasis.
Urogenital
Impotence, polyuria, prostate disorder, abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.
4DESCRIPTION
APLENZIN
APLENZIN tablets are supplied for oral administration as 174 mg, 348 mg, and 522 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrobromide and the inactive ingredients: ethylcellulose, glyceryl dibehenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths. The tablets are printed with edible black ink.
The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.
5HOW SUPPLIED/STORAGE AND HANDLING
APLENZIN
APLENZIN
APLENZIN
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors
Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment
Although APLENZIN is not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN which is approved for this use. Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion. Instruct patients to discontinue APLENZIN and contact a healthcare professional if they experience such symptoms
Severe Allergic Reactions
Educate patients on the symptoms of hypersensitivity and to discontinue APLENZIN if they have a severe allergic reaction.
Seizure
Instruct patients to discontinue and not restart APLENZIN if they experience a seizure while on treatment. Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid the use of alcohol.
Angle-Closure Glaucoma
Patients should be advised that taking APLENZIN can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible
Bupropion-Containing Products
Educate patients that APLENZIN contains the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that APLENZIN should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as WELLBUTRIN XL, the extended-release formulation, WELLBUTRIN SR, the sustained-release formulation, and WELLBUTRIN, the immediate-release formulation). In addition, there are a number of generic bupropion HCl products for the immediate, sustained, and extended-release formulations.
Potential for Cognitive and Motor Impairment
Advise patients that any CNS-active drug like APLENZIN tablets may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that APLENZIN tablets do not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. APLENZIN treatment may lead to decreased alcohol tolerance.
Concomitant Medications
Counsel patients to notify their healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs, because APLENZIN tablets and other drugs may affect each other’s metabolism.
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with APLENZIN. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to APLENZIN during pregnancy
Administration Information
Instruct patients to swallow APLENZIN tablets whole so that the release rate is not altered. Instruct patients if they miss a dose, not to take an extra tablet to make up for the missed dose and to take the next tablet at the regular time because of the dose-related risk of seizure. Instruct patients that APLENZIN tablets should be swallowed whole and not crushed, divided, or chewed. APLENZIN can be taken with or without food.
Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
APLENZIN is a registered trademark of Bausch Health Companies Inc. or its affiliates.
Wellbutrin XL is a registered trademark of GlaxoSmithKline LLC used under license.
All other product/brand names and/or logos are the trademarks of their respective owners.
U.S. Patent Numbers: 7,241,805; 7,569,610; 7,572,935; 7,585,897; 7,645,802; 7,649,019; 7,662,407 and 7,671,094
© 2025 Bausch Health Companies Inc. or its affiliates
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