BUPROPION HYDROCHLORIDE tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Available from:
Proficient Rx LP
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)]. Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal major depressive episodes was established
Product summary:
Bupropion hydrochloride extended-release tablets, USP (XL) 150 mg are creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side. They are supplied as follows:        Bottles of 30 (NDC 71205-504-30)        Bottles of 60 (NDC 71205-504-60)        Bottles of 90 (NDC 71205-504-90) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from light. Bupropion hydrochloride extended-release tablets, USP (XL) may have an odor.
Authorization status:
Abbreviated New Drug Application
Authorization number:
71205-504-30, 71205-504-60, 71205-504-90

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BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, extended release

Proficient Rx LP

----------

MEDICATION GUIDE

Bupropion Hydrochloride

Extended-Release Tablets (XL)

(bue-PROE-pee-on HYE-

droe-KLOR-ide)

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 tablets (XL)?”

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?

Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children,

teenagers, or young adults within the first few months of treatment.

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.

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

trouble sleeping (insomnia)

attempts to commit suicide

new or worse irritability

new or worse depression

acting aggressive, being angry, or violent

new or worse anxiety

acting on dangerous impulses

feeling very agitated or restless

an extreme increase in activity and talking (mania)

panic attacks

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 tablets (XL) 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.

Although bupropion hydrochloride extended-release tablets (XL) are 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:

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 effects 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 tablets (XL) 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 tablets (XL). In

many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets

(XL), but in some people symptoms continued after stopping bupropion hydrochloride extended-release

tablets (XL). It is important for you to follow-up with your healthcare provider until your symptoms go

away. Before taking bupropion hydrochloride extended-release tablets (XL), 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

tablets (XL)?

Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride

extended-release tablets (XL), 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

tablets (XL). For more information, see the sections “ Who should not take bupropion hydrochloride

extended-release tablets (XL)?” and “ What should I tell my healthcare provider before taking bupropion

hydrochloride extended-release tablets (XL)?” 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 tablets (XL) unless your healthcare provider has said it is okay

to take them.

If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the

tablets and call your healthcare provider right away. Do not take bupropion hydrochloride extended-

release tablets (XL) 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 tablets (XL). 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 bupropion

hydrochloride extended-release tablets (XL)?”).

Manic episodes. Some people may have periods of mania while taking bupropion hydrochloride

extended-release tablets (XL), 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 extended-release tablets (XL), 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 tablets (XL). Stop taking bupropion hydrochloride extended-release

tablets (XL) 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 tablets (XL)?

Bupropion hydrochloride extended-release tablets (XL) should be used with a patient support program. It

is important to participate in the behavioral program, counseling, or other support program your

healthcare professional recommends.

Quitting smoking can lower your chances of having lung disease, heart disease, or getting certain types of

cancer that are related to smoking.

Who should not take bupropion hydrochloride extended-release tablets (XL)?

Do not take bupropion hydrochloride extended-release tablets (XL) 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, including WELLBUTRIN or

WELLBUTRIN SR, APLENZIN ®, ZYBAN, or FORFIVO XL ®Bupropion is the same active

ingredient that is in bupropion hydrochloride extended-release tablets (XL).

drink a lot of alcohol and abruptly stop drinking, or take medicines called sedatives (these make you

sleepy), benzodiazepines, or anti-seizure medicines, and you stop taking 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

tablets (XL) unless directed to do so by your healthcare provider.

do not start bupropion hydrochloride extended-release tablets (XL) 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 tablets (XL),

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 tablets (XL).

What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets

(XL)?

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, 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 hydrochloride extended-release

tablets (XL). See “Quitting Smoking, Quit-Smoking Medications, Changes in Thinking Behavior, and

Depression, 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.

are breastfeeding. Bupropion 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 tablets (XL).

How should I take bupropion hydrochloride extended-release tablets (XL)?

Start bupropion hydrochloride extended-release tablets (XL) before you stop smoking to give

bupropion hydrochloride extended-release tablets (XL) time to build up in your body. It takes about

1 week for bupropion hydrochloride extended-release tablets (XL) to start working.

Pick a date to stop smoking that is during the second week you are taking bupropion hydrochloride

extended-release tablets (XL).

Take bupropion hydrochloride extended-release tablets (XL) exactly as prescribed by your

healthcare provider. Do not change your dose or stop taking bupropion hydrochloride extended-

release tablets (XL) without talking with your healthcare provider first.

Bupropion hydrochloride extended-release tablets (XL) are usually taken for 7 to 12 weeks. Your

healthcare provider may decide to prescribe bupropion hydrochloride extended-release tablets (XL)

for longer than 12 weeks to help you stop smoking. Follow your healthcare provider’s instructions.

Swallow bupropion hydrochloride extended-release tablets (XL) whole. Do not chew, cut, or crush

bupropion hydrochloride extended-release tablets (XL). 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 tablets (XL) may have an odor. This is normal.

Take your doses of bupropion hydrochloride extended-release tablets (XL) at least 8 hours apart.

You may take bupropion hydrochloride extended-release tablets (XL) with or without food.

It is not dangerous to smoke and take bupropion hydrochloride extended-release tablets (XL) at the

same time. But, you will lower your chance of breaking your smoking habit if you smoke after the

date you set to stop smoking.

You may use bupropion hydrochloride extended-release tablets (XL) and nicotine patches (a type of

nicotine replacement therapy) at the same time, following the precautions below.

You should only use bupropion hydrochloride extended-release tablets (XL) and nicotine patches

together under the care of your healthcare provider. Using bupropion hydrochloride extended-

release tablets (XL) and nicotine patches together may raise your blood pressure, and sometimes

this can be severe.

Tell your healthcare provider if you plan to use nicotine patches. Your healthcare provider should

check your blood pressure regularly if you use nicotine patches with bupropion hydrochloride

extended-release tablets (XL) to help you quit smoking.

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 tablets (XL) can increase your chance of having a seizure.

If you take too much bupropion hydrochloride extended-release tablets (XL), 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 tablets (XL)

unless your healthcare provider has told you it is okay.

What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)?

Limit or avoid using alcohol during treatment with bupropion hydrochloride extended-release

tablets (XL). 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 tablets (XL) affect you. Bupropion hydrochloride extended-release tablets (XL) can affect

your ability to do these things safely.

What are possible side effects of bupropion hydrochloride extended-release tablets (XL)?

Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects. See the sections at

the beginning of this Medication Guide for information about serious side effects of bupropion

hydrochloride extended-release tablets (XL).

The most common side effects of bupropion hydrochloride extended-release tablets (XL) include:

trouble sleeping

feeling anxious

stuffy nose

nausea

dry mouth

constipation

dizziness

joint aches

If you have trouble sleeping, do not take bupropion hydrochloride extended-release tablets (XL) 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 tablets (XL). 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 Accord Healthcare Inc. at 1-866-941-7875

How should I store bupropion hydrochloride extended-release tablets (XL)?

Store bupropion hydrochloride extended-release tablets (XL) at room temperature between 59°F

and 86°F (15°C to 30°C).Protect from light.

Keep bupropion hydrochloride extended-release tablets (XL) and all medicines out of the reach of

children.

General information about the safe and effective use of bupropion hydrochloride extended-release tablets

(XL).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use bupropion hydrochloride extended-release tablets (XL) for a condition for which it was not

prescribed. Do not give bupropion hydrochloride extended-release tablets (XL) 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 tablets (XL) 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 tablets (XL), 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 tablets (XL). 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

tablets (XL) that is written for health professionals.

For more information about bupropion hydrochloride extended-release tablets (XL), go to

www.accordhealthcare.us or call Accord Healthcare at 1-866-941-7875.

What are the ingredients in bupropion hydrochloride extended-release tablets (XL)?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol

dibehanate, magnesium stearate, ethyl cellulose, polyethylene glycol, colloidal hydrated silica, triethyl

citrate, methacrylic acid - ethyl acrylate copolymer , shellac, iron oxide black and propylene glycol.

Manufactured For:

Accord Healthcare, Inc.,

1009, Slater Road,

Suite 210-B,

Durham, NC 27703,

Manufactured By:

Intas Pharmaceuticals Limited,

Plot No. : 457, 458,

Village - Matoda,

Bavla Road, Ta.- Sanand,

Dist.- Ahmedabad - 382 210,

INDIA.

This Medication Guide has been approved by the U.S. Food and Drug Administration

All other product/brand names are the trademarks of their respective owners.

10 0390 0 666435

Issued June 2018

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

Revised: 11/2020

Document Id: 42201f4a-8856-4499-8bc3-d18612b1ec34

34391-3

Set id: 42201f4a-8856-4499-8bc3-d18612b1ec34

Version: 1

Effective Time: 20201101

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BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, extended release

Proficient Rx LP

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE

EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION

HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL).

BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use

Initial U.S. Approval: 1985

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

INDICATIONS AND USAGE

Bupropion hydrochloride extended-release tablets (XL) are aminoketone antidepressant, indicated for the treatment of

major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term

usefulness for the individual patient. ( 1)

DOSAGE AND ADMINISTRATION

Ge ne ral:

Major Depressive Disorder

Seasonal Affective Disorder

Hepatic Impairment

Renal Impairment

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking

antide pre ssants.

Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1)

Increase dose gradually to reduce seizure risk. ( 2.1, 5.3)

Periodically reassess the dose and need for maintenance treatment. ( 2.2)

Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily ( 2.2)

After 4 days, may increase the dose to 300 mg once daily. ( 2.2)

Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.3)

Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. ( 2.3)

After one week, may increase the dose to 300 mg once daily. ( 2.3)

Continue treatment through the winter season. ( 2.3)

Moderate to severe hepatic impairment: 150 mg every other day ( 2.6)

Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6, 8.7)

Consider reducing the dose and/or frequency of dosing. ( 2.7, 8.6)

Extended-release tablets: 150 mg, 300 mg ( 3)

Seizure disorder. ( 4, 5.3)

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Most common adverse reactions are (incidence ≥5%; ≥2× placebo rate): dry mouth, nausea, insomnia, dizziness,

pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency,

rash. ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or

www.accordhealthcare.us or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2020

Current or prior diagnosis of bulimia or anorexia nervosa ( 4, 5.3)

Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( 4, 5.3)

Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion

hydrochloride extended-release tablets (XL) or within 14 days of stopping treatment with bupropion hydrochloride

extended-release tablets (XL). Do not use bupropion hydrochloride extended-release tablets (XL) within 14 days of

stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride extended-

release tablets (XL) in a patient who is being treated with linezolid or intravenous methylene blue. ( 4, 7.6)

Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL)

( 4, 5.8)

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 hydrochloride extended-release tablets (XL) for the occurrence of such symptoms and instruct them to

discontinue bupropion hydrochloride extended-release tablets (XL) and contact a healthcare provider if they

experience such adverse events. ( 5.2)

Seizure Risk: The risk is dose-related. Can minimize risk by limiting daily dose to 450 mg and gradually increasing the

dose. Discontinue if seizure occurs. ( 4, 5.3, 7.3)

Hypertension: Bupropion hydrochloride extended-release tablets (XL) 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)

CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir,

lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical exposure, 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 tablets (XL) with caution. ( 5.3,

7.3)

Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion

hydrochloride extended-release tablets (XL). ( 7.4)

MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride

extended-release tablets (XL). ( 7.6)

Drug-laboratory test interactions: Bupropion hydrochloride extended-release tablets (XL) can cause false- positive

urine test results for amphetamines. ( 7.7)

Pregnancy: Use only if benefit outweighs potential risk to the fetus. ( 8.1)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder

1.2 Seasonal Affective Disorder

2 DOSAGE AND ADMINISTRATION

2.1 General Instructions for Use

2.2 Dosage for Major Depressive Disorder (MDD)

2.3 Dosage for Seasonal Affective Disorder (SAD)

2.4 Switching Patients from WELLBUTRIN Tablets or from WELLBUTRIN SR Sustained-Release

Tablets

2.5 To Discontinue Bupropion Hydrochloride Extended-Release Tablets (XL), Taper the Dose

2.6 Dosage Adjustment in Patients with Hepatic Impairment

2.7 Dose Adjustment in Patients with Renal Impairment

2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

2.9 Use of Bupropion Hydrochloride Extended-Release Tablets (XL) with Reversible MAOIs such

as Linezolid or Methylene Blue

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

5.2 Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment

5.3 Seizure

5.4 Hypertension

5.5 Activation of Mania/Hypomania

5.6 Psychosis and Other Neuropsychiatric Reactions

5.7 Angle-Closure Glaucoma

5.8 Hypersensitivity Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-Release Tablets (XL)

7.2 Potential for Bupropion Hydrochloride Extended-Release Tablets (XL) to Affect Other Drugs

7.3 Drugs That Lower Seizure Threshold

7.4 Dopaminergic Drugs (Levodopa and Amantadine)

7.5 Use with Alcohol

7.6 MAO Inhibitors

7.7 Drug-Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

10 OVERDOSAGE

10.1 Human Overdose Experience

10.2 Overdosage Management

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Major Depressive Disorder

14.2 Seasonal Affective Disorder

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

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 [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)].

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder

Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major

depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

The efficacy of the immediate-release formulation of bupropion was established in two 4-week

controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The

efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was

established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to

bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)].

1.2 Seasonal Affective Disorder

Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal

major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).

The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal

major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a

history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies

(14.2)].

Sections or subsections omitted from the full prescribing information are not listed.

2 DOSAGE AND ADMINISTRATION

2.1 General Instructions for Use

To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3)].

Bupropion hydrochloride extended-release tablets (XL) should be swallowed whole and not crushed,

divided, or chewed. Bupropion hydrochloride extended-release tablets (XL) should be administered in

the morning and may be taken with or without food.

2.2 Dosage for Major Depressive Disorder (MDD)

The recommended starting dose for MDD is 150 mg once daily in the morning. After 4 days of dosing,

the dose may be increased to the target dose of 300 mg once daily in the morning.

It is generally agreed that acute episodes of depression require several months or longer of

antidepressant treatment beyond the response in the acute episode. It is unknown whether the bupropion

hydrochloride extended-release tablets (XL) dose needed for maintenance treatment is identical to the

dose that provided an initial response. Periodically reassess the need for maintenance treatment and the

appropriate dose for such treatment.

2.3 Dosage for Seasonal Affective Disorder (SAD)

The recommended starting dose for SAD is 150 mg once daily. After 7 days of dosing, the dose may be

increased to the target dose of 300 mg once daily in the morning. Doses above 300 mg of bupropion

HCl extended-release were not assessed in the SAD trials.

For the prevention of seasonal MDD episodes associated with SAD, initiate bupropion hydrochloride

extended-release tablets (XL) in the autumn, prior to the onset of depressive symptoms. Continue

treatment through the winter season. Taper and discontinue bupropion hydrochloride extended-release

tablets (XL) in early spring. For patients treated with 300 mg per day, decrease the dose to 150 mg once

daily before discontinuing bupropion hydrochloride extended-release tablets (XL). Individualize the

timing of initiation, and duration of treatment should be individualized, based on the patient’s historical

pattern of seasonal MDD episodes.

2.4 Switching Patients from WELLBUTRIN Tablets or from WELLBUTRIN SR Sustained-

Release Tablets

When switching patients from WELLBUTRIN Tablets to bupropion hydrochloride extended-release

tablets (XL) or from WELLBUTRIN SR Sustained-Release Tablets to bupropion hydrochloride

extended-release tablets (XL), give the same total daily dose when possible.

2.5 To Discontinue Bupropion Hydrochloride Extended-Release Tablets (XL), Taper the Dose

When discontinuing treatment in patients treated with bupropion hydrochloride extended-release tablets

(XL) 300 mg once daily, decrease the dose to 150 mg once daily prior to discontinuation.

2.6 Dosage Adjustment in Patients with Hepatic Impairment

In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is

150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider

reducing the dose and/or frequency of dosing [see Use in Specific Populations (8.7) and Clinical

Pharmacology (12.3)].

2.7 Dose Adjustment in Patients with Renal Impairment

Consider reducing the dose and/or frequency of bupropion hydrochloride in patients with renal

impairment (glomerular filtration rate less than 90 mL/min) [see Use in Specific Populations (8.6) and

Clinical Pharmacology (12.3)] .

2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and

initiation of therapy with bupropion hydrochloride extended-release tablets (XL). Conversely, at least

14 days should be allowed after stopping bupropion hydrochloride extended-release tablets (XL)

before starting an MAOI antidepressant [see Contraindications (4) and Drug Interactions (7.6)].

2.9 Use of Bupropion Hydrochloride Extended-Release Tablets (XL) with Reversible MAOIs

such as Linezolid or Methylene Blue

Do not start bupropion hydrochloride extended-release tablets (XL) in a patient who is being treated

with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase

risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric

condition, non-pharmacological interventions, including hospitalization, should be considered [see

Contraindications (4)].

In some cases, a patient already receiving therapy with bupropion hydrochloride extended-release

tablets (XL) may require urgent treatment with linezolid or intravenous methylene blue. If acceptable

alternatives to linezolid or intravenous methylene blue treatment are not available and the potential

benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of

hypertensive reactions in a particular patient, bupropion hydrochloride extended-release tablets (XL)

should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The

patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous

methylene blue, whichever comes first. Therapy with bupropion hydrochloride extended-release

tablets (XL) may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local

injection) or in intravenous doses much lower than 1 mg per kg with bupropion hydrochloride extended-

release tablets (XL) is unclear. The clinician should, nevertheless, be aware of the possibility of a drug

interaction with such use [see Contraindications (4) and Drug Interactions (7.6)].

3 DOSAGE FORMS AND STRENGTHS

Bupropion hydrochloride extended-release tablets, USP (XL) 150 mg are creamy-white to pale yellow,

round tablets printed with “GS1” on one side and plain on the other side.

Bupropion hydrochloride extended-release tablets, USP (XL) 300 mg are creamy-white to pale yellow,

round tablets printed with “GS2” on one side and plain on the other side.

4 CONTRAINDICATIONS

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with

seizure disorder.

Bupropion hydrochloride extended-release tablets (XL) 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 bupropion hydrochloride extended-release tablets (XL) [see

Warnings and Precautions (5.3)].

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing

abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see

Warnings and Precautions (5.3) and Drug Interactions (7.3)].

The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion

hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with

bupropion hydrochloride extended-release tablets (XL) is contraindicated. There is an increased

risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of

their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes

in behavior, whether or not they are taking antidepressant medications, and this risk may persist until

significant remission occurs. Suicide is a known risk of depression and certain other psychiatric

disorders, and these disorders themselves are the strongest predictors of suicide. There has been a

long-standing concern that antidepressants may have a role in inducing worsening of depression and the

emergence of suicidality in certain patients during the early phases of treatment.

Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (Selective Serotonin

Reuptake Inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and

behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive

disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk

of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction

with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive

compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9

antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults

with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2

months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of

suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs

studied. There were differences in absolute risk of suicidality across the different indications, with the

highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable

within age strata and across indications. These risk differences (drug-placebo difference in the number

of cases of suicidality per 1000 patients treated) are provided in Table 1.

Table 1: Risk Differences in the Number of Suicidality Cases by Age Group in the Pooled

Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients

Age Range

Drug-Placebo Difference in Number of Cases

of Suicidality per 1000 Patients Treated

Increases Compared to Placebo

<18 years

14 additional cases

18 to 24 years

5 additional cases

Decreases Compared to Placebo

25 to 64 years

1 fewer case

≥65 years

6 fewer cases

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the

used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets

(XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting

bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs

such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration

(2.9), Warnings and Precautions (5.4) and Drug Interactions (7.6)].

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known

hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release

tablets (XL). Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been

reported [see Warnings and Precautions (5.8)].

number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with

depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored

appropriately and observed closely for clinical worsening, suicidality, and unusual changes in

behavior, especially during the initial few months of a course of drug therapy, or at times of dose

changes, either increases or decreases [see Boxed Warning and Use in Specific Populations (8.4)].

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility,

aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been

reported in adult and pediatric patients being treated with antidepressants for major depressive disorder

as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the

emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal

impulses has not been established, there is concern that such symptoms may represent precursors to

emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing

the medication, in patients whose depression is persistently worse, or who are experiencing emergent

suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if

these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive

disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the

need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior,

and the other symptoms described above, as well as the emergence of suicidality, and to report

such symptoms immediately to healthcare providers. Such monitoring should include daily

observation by families and caregivers. Prescriptions for bupropion hydrochloride extended-

release tablets (XL) should be written for the smallest quantity of tablets consistent with good

patient management, in order to reduce the risk of overdose.

5.2 Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment

Bupropion hydrochloride extended-release tablets (XL) are not approved for smoking cessation

treatment; however, bupropion HCl sustained-release is approved for this use. Serious

neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation.

These postmarketing reports 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 [see Adverse

Reactions (6.2)]. Some patients who stopped smoking may have been experiencing symptoms of nicotine

withdrawal, including depressed mood. Depression, rarely including suicidal ideation, has been

reported in smokers undergoing a smoking cessation attempt without medication. However, some of

these adverse events occurred in patients taking bupropion who continued to smoke.

Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric

disease; some patients experienced worsening of their psychiatric illnesses.

Observe patients for the occurrence of neuropsychiatric adverse events. Advise patients and

caregivers that the patient should stop taking bupropion hydrochloride extended-release tablets

(XL) and contact a healthcare provider immediately if agitation, depressed mood, or changes in

behavior or thinking that are not typical for the patient are observed, or if the patient develops

suicidal ideation or suicidal behavior. The healthcare provider should evaluate the severity of the

adverse events and the extent to which the patient is benefiting from treatment, and consider

options including continued treatment under closer monitoring, or discontinuing treatment. In many

postmarketing cases, resolution of symptoms after discontinuation of bupropion was reported.

5.3 Seizure

Bupropion hydrochloride extended-release tablets (XL) can cause seizure. The risk of seizure is dose-

related. The dose should not exceed 300 mg once daily. Increase the dose gradually. Discontinue

bupropion hydrochloride extended-release tablets (XL) and do not restart treatment if the patient

experiences a seizure.

The risk of seizures is also related to patient factors, clinical situations, and concomitant medications

that lower the seizure threshold. Consider these risks before initiating treatment with bupropion

hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL)

are contraindicated in patients with a seizure disorder or conditions that increase the risk of seizure

(e.g., severe head injury, arteriovenous malformation, CNS tumor or CNS infection, severe stroke,

anorexia nervosa or bulimia, or abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and

antiepileptic drugs [see Contraindications (4)]. The following conditions can also increase the risk of

seizure: concomitant use of other medications that lower the seizure threshold (e.g., other bupropion

products, antipsychotics, tricyclic antidepressants, theophylline, and systemic corticosteroids),

metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia), or use

of illicit drugs (e.g., cocaine) or abuse or misuse of prescription drugs such as CNS stimulants.

Additional predisposing conditions include diabetes mellitus treated with oral hypoglycemic drugs or

insulin, use of anorectic drugs, excessive use of alcohol, benzodiazepines, sedative/hypnotics, or

opiates.

Incidence of Seizure with Bupropion Use

The incidence of seizure with bupropion hydrochloride extended-release tablets (XL) has not been

formally evaluated in clinical trials. In studies using bupropion HCl sustained-release up to 300 mg per

day the incidence of seizure was approximately 0.1% (1/1000 patients). In a large prospective, follow-

up study, the seizure incidence was approximately 0.4% (13/3200) with bupropion HCl immediate-

release in the range of 300 mg to 450 mg per day.

Additional data accumulated for bupropion immediate-release suggests that the estimated seizure

incidence increases almost tenfold between 450 mg and 600 mg/day. The risk of seizure can be reduced

if the bupropion hydrochloride extended-release tablets (XL) dose does not exceed 450 mg once daily

and the titration rate is gradual.

5.4 Hypertension

Treatment with bupropion hydrochloride extended-release tablets (XL) can result in elevated blood

pressure and hypertension.

Assess blood pressure before initiating treatment with bupropion hydrochloride extended-release

tablets (XL), and monitor periodically during treatment. The risk of hypertension is increased if

bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs or other

drugs that increase dopaminergic or noradrenergic activity [see Contraindications (4)].

Data from a comparative trial of the sustained-release formulation of bupropion HCl, nicotine

transdermal system (NTS), the combination of sustained-release bupropion plus NTS, and placebo as an

aid to smoking cessation suggest a higher incidence of treatment-emergent hypertension in patients

treated with the combination of sustained-release bupropion and NTS. In this trial, 6.1% of subjects

treated with the combination of sustained-release bupropion and NTS had treatment-emergent

hypertension compared to 2.5%, 1.6%, and 3.1% of subjects treated with sustained-release bupropion,

NTS, and placebo, respectively. The majority of these subjects had evidence of pre-existing

hypertension. Three subjects (1.2%) treated with the combination of sustained-release bupropion and

NTS and 1 subject (0.4%) treated with NTS had study medication discontinued due to hypertension

compared with none of the subjects treated with sustained-release bupropion or placebo. Monitoring of

However, the symptoms persisted in some cases; therefore, ongoing monitoring and supportive

care should be provided until symptoms resolve.

compared with none of the subjects treated with sustained-release bupropion or placebo. Monitoring of

blood pressure is recommended in patients who receive the combination of bupropion and nicotine

replacement.

In the 3 trials of bupropion HCl extended-release in seasonal affective disorder, there were significant

elevations in blood pressure. Hypertension was reported as an adverse reaction for 2% of the

bupropion group (11/537) and none in the placebo group (0/511). In the SAD trials, 2 patients treated

with bupropion discontinued from the study because they developed hypertension. None of the placebo

group discontinued because of hypertension. The mean increase in systolic blood pressure was 1.3

mmHg in the bupropion group and 0.1 mmHg in the placebo group. The difference was statistically

significant (p=0.013). The mean increase in diastolic blood pressure was 0.8 mmHg in the bupropion

group and 0.1 mmHg in the placebo group. The difference was not statistically significant (p=0.075). In

the SAD trials, 82% of patients were treated with 300 mg per day, and 18% were treated with 150 mg

per day. The mean daily dose was 270 mg per day. The mean duration of bupropion exposure was 126

days.

In a clinical trial of bupropion immediate-release in MDD subjects with stable congestive heart failure

(N=36), bupropion was associated with an exacerbation of pre-existing hypertension in 2 subjects,

leading to discontinuation of bupropion treatment. There are no controlled studies assessing the safety

of bupropion in patients with a recent history of myocardial infarction or unstable cardiac disease.

5.5 Activation of Mania/Hypomania

Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears

to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to

initiating bupropion hydrochloride extended-release tablets (XL), screen patients for a history of

bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar

disorder, suicide, or depression). Bupropion hydrochloride extended-release tablets (XL) are not

approved for the treatment of bipolar depression.

5.6 Psychosis and Other Neuropsychiatric Reactions

Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms,

including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Some

of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated upon dose

reduction and/or withdrawal of treatment. Discontinue bupropion hydrochloride extended-release

tablets (XL) if these reactions occur.

5.7 Angle-Closure Glaucoma

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant

drugs including bupropion hydrochloride extended-release tablets (XL) may trigger an angle-closure

attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

5.8 Hypersensitivity Reactions

Anaphylactoid/anaphylactic reactions have occurred during clinical trials with bupropion. Reactions

have been characterized by pruritus, urticaria, angioedema, and dyspnea, requiring medical treatment. In

addition, there have been rare, spontaneous postmarketing reports of erythema multiforme, Stevens-

Johnson Syndrome, and anaphylactic shock associated with bupropion. Instruct patients to discontinue

bupropion hydrochloride extended-release tablets (XL) and consult a healthcare provider if they

develop an allergic or anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus, hives, chest pain,

edema, and shortness of breath) during treatment.

There are reports of arthralgia, myalgia, fever with rash and other symptoms of serum sickness

suggestive of delayed hypersensitivity.

6 ADVERSE REACTIONS

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