WELLBUTRIN SR bupropion hydrochloride
Refer to the “Also Known As” section to reference different products that include the same medication as WELLBUTRIN SR.
Drug Basics
Brand Name: WELLBUTRIN SR
Generic Name: BUPROPION HYDROCHLORIDE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: TABLET, FILM COATED
Packager: GlaxoSmithKline LLC
Data Current As Of: 2021-02-11
Indications & Usage
WELLBUTRIN SR (bupropion hydrochloride) is 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 WELLBUTRIN SR 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)].
- WELLBUTRIN SR is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
Patient 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 healthcare 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 WELLBUTRIN SR 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 bupropion and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].
Severe Allergic Reactions
Educate patients on the symptoms of hypersensitivity and to discontinue WELLBUTRIN SR if they have a severe allergic reaction.
Seizure
Instruct patients to discontinue and not restart WELLBUTRIN SR if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid use of alcohol.
As the dose is increased during initial titration to doses above 150 mg/day, instruct patients to take WELLBUTRIN SR in 2 divided doses, preferably with at least 8 hours between successive doses, to minimize the risk of seizures.
Angle-Closure Glaucoma
Patients should be advised that taking WELLBUTRIN SR 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 [see Warnings and Precautions (5.7)].
Bupropion-Containing Products
Educate patients that WELLBUTRIN SR contains the same active ingredient (bupropion hydrochloride) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that WELLBUTRIN SR should not be used in combination with ZYBAN or any other medications that contain bupropion (such as WELLBUTRIN, the immediate-release formulation and WELLBUTRIN XL or FORFIVO XL, the extended-release formulations, and APLENZIN, the extended-release formulation of bupropion hydrobromide). 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 WELLBUTRIN SR may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that WELLBUTRIN SR does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. WELLBUTRIN SR 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 WELLBUTRIN SR sustained-release tablets and other drugs may affect each others’ metabolisms.
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with WELLBUTRIN SR. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to WELLBUTRIN SR during pregnancy [see Use in Specific Populations (8.1)].
Storage Information
Instruct patients to store WELLBUTRIN SR at room temperature, between 68°F and 77°F (20°C to 25°C) and keep the tablets dry and out of the light.
Administration Information
Instruct patients to swallow WELLBUTRIN SR tablets whole so that the release rate is not altered. Do not chew, divide, or crush tablets; they are designed to slowly release drug in the body. When patients take more than 150 mg/day, instruct them to take WELLBUTRIN SR in 2 doses at least 8 hours apart, to minimize the risk of seizures. 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 WELLBUTRIN SR tablets may have an odor. WELLBUTRIN SR can be taken with or without food.
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 owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2020 GSK group of companies or its licensor.
WLS:19PI
Medication Guide WELLBUTRIN SR (WELL byu-trin) (bupropion hydrochloride) Sustained‑Release Tablets |
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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 WELLBUTRIN SR?” |
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Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions |
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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?
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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: |
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What else do I need to know about antidepressant medicines?
It is not known if WELLBUTRIN SR is safe and effective in children under the age of 18. |
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Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions |
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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. Although WELLBUTRIN SR is not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN which is used to help patients quit smoking. Talk to your healthcare provider or your family member’s healthcare provider about:
When you try to quit smoking, with or without bupropion you may have symptoms that may be due to nicotine withdrawal, including: |
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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 WELLBUTRIN SR 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 WELLBUTRIN SR. In many people, these symptoms went away after stopping WELLBUTRIN SR, but in some people, symptoms continued after stopping WELLBUTRIN SR. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking WELLBUTRIN SR, 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. |
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What Other Important Information Should I Know About WELLBUTRIN SR? |
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What is WELLBUTRIN SR? WELLBUTRIN SR is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder. |
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Who should not take WELLBUTRIN SR? Do not take WELLBUTRIN SR if you
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What should I tell my healthcare provider before taking WELLBUTRIN SR? 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 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 WELLBUTRIN SR. |
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How should I take WELLBUTRIN SR?
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What should I avoid while taking WELLBUTRIN SR?
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What are possible side effects of WELLBUTRIN SR? WELLBUTRIN SR can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of WELLBUTRIN. The most common side effects of WELLBUTRIN SR include: |
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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 WELLBUTRIN SR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088. You may also report side effects to GlaxoSmithKline at 1-888-825-5249. |
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How should I store WELLBUTRIN SR?
Keep WELLBUTRIN SR and all medicines out of the reach of children. |
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General information about the safe and effective use of WELLBUTRIN SR. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use WELLBUTRIN SR for a condition for which it was not prescribed. Do not give WELLBUTRIN SR to other people, even if they have the same symptoms you have. It may harm them. If you take a urine drug screening test, WELLBUTRIN SR may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking WELLBUTRIN SR, they can do a more specific drug screening test that should not have this problem. This Medication Guide summarizes important information about WELLBUTRIN SR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about WELLBUTRIN SR that is written for healthcare professionals. For more information about WELLBUTRIN SR, call 1-888-825-5249. |
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What are the ingredients in WELLBUTRIN SR? Active ingredient: bupropion hydrochloride. Inactive ingredients: carnauba wax, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide. The tablets are printed with edible black ink. In addition, the 100‑mg tablet contains FD&C Blue No. 1 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 FD&C Red No. 40 Lake. The tablets are printed with edible black ink. GlaxoSmithKline Research Triangle Park, NC 27709 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 owned or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products. ©2019 GSK group of companies or its licensor. WLS:15MG |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2019
PRINCIPAL DISPLAY PANEL
NDC 0173-0947-55
Wellbutrin SR
(bupropion HCl)
Sustained-Release Tablets
Rx only
Twice-A-Day
(After Initial Titration)
100 mg
Each sustained-release tablet contains 100 mg bupropion HCl.
WARNING: Do not use with other medicines that contain bupropion HCl.
Federal Law requires dispensing of Wellbutrin SR with the Medication Guide provided with this bottle.
See prescribing information for dosage information.
Store at controlled room temperature, 68o to 77oF (20o to 25oC) [see USP].
Keep dry and out of light.
60 Tablets
GlaxoSmithKline
RTP, NC 27709
Made in Spain
Trademark owned or licensed by GSK.
©2019 GSK or licensor.
- 62000000041493 Rev. 7/19
PRINCIPAL DISPLAY PANEL
NDC 0173-0135-55
Wellbutrin SR
(bupropion HCl)
Sustained-Release Tablets
Rx only
Twice-A-Day
(After Initial Titration)
150 mg
Each sustained-release tablet contains 150 mg bupropion HCl.
WARNING: Do not use with other medicines that contain bupropion HCl.
Federal Law requires dispensing of Wellbutrin SR with the Medication Guide provided with this bottle.
See prescribing information for dosage information.
Store at controlled room temperature, 68o to 77oF (20o to 25oC) [see USP].
Keep dry and out of light.
60 Tablets
GlaxoSmithKline
RTP, NC 27709
Made in Spain
Trademark owned or licensed by GSK.
©2019 GSK or licensor.
- 62000000041495 Rev. 7/19
PRINCIPAL DISPLAY PANEL
NDC 0173-0722-00
WellbutrinSR
(bupropion HCl)
Sustained-Release Tablets
Rx only
Twice-A-Day
(After Initial Titration)
200 mg
Each sustained-release tablet contains 200 mg bupropion HCl.
WARNING: Do not use with other medicines that contain bupropion HCl.
Federal Law requires dispensing of Wellbutrin SR with the Medication Guide provided with this bottle.
See prescribing information for dosage information.
Store at controlled room temperature, 68o to 77oF (20o to 25oC) [see USP].
Keep dry and out of light.
60 Tablets
GlaxoSmithKline
RTP, NC 27709
Made in Spain
Trademark owned or licensed by GSK.
©2019 GSK or licensor.
- 62000000041494 Rev. 7/19
also known as
- bupropion (tablet, extended release)
- BUPROPION HCL ER XL (tablet, extended release)
- Bupropion hydrochloride (tablet, extended release)
- BUPROPION HYDROCHLORIDE (SR) (tablet, extended release)
- Bupropion Hydrochloride (SR) (tablet, film coated, extended release)
- Bupropion Hydrochloride (tablet, film coated, extended release)
- Bupropion hydrochloride (XL) (tablet, extended release)
- Bupropion Hydrochloride (XL) (tablet, film coated, extended release)
- Bupropion Hydrochloride Extended Release (tablet)
- BUPROPION HYDROCHLORIDE SR (tablet, extended release)
- Bupropion Hydrochloride SR (tablet, film coated, extended release)
- Bupropion Hydrochloride XL (tablet, extended release)
- Bupropion Hydrochloride XL (tablet, film coated, extended release)
- Bupropion HydrochlorideXL XL (tablet, film coated, extended release)
- Forfivo XL (tablet, film coated, extended release)
- WELLBUTRIN XL (tablet, extended release)
- ZYBAN (tablet, film coated)