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Wellbutrin srNDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 56 (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Based on these limited data, it
is unknown whether or not the dose of WELLBUTRIN SR needed for maintenance treatment is
identical to the dose needed to achieve an initial response. Patients should be periodically
reassessed to determine the need for maintenance treatment and the appropriate dose for such
Dosage Adjustment for Patients with Impaired Hepatic Function: WELLBUTRIN SR
should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not
exceed 100 mg every day or 150 mg every other day in these patients. WELLBUTRIN SR should
be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic
cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to
moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and
Dosage Adjustment for Patients with Impaired Renal Function: WELLBUTRIN SR
should be used with caution in patients with renal impairment and a reduced frequency and/or dose
should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
WELLBUTRIN SR Sustained-Release Tablets, 100 mg of bupropion hydrochloride, are blue, round, biconvex, film-coated tablets printed with “WELLBUTRIN SR 100” in bottles of 60 (NDC 0173-0947-55) tablets. WELLBUTRIN SR Sustained-Release Tablets, 150 mg of bupropion hydrochloride, are purple, round, biconvex, film-coated tablets printed with "WELLBUTRIN SR 150" in bottles of 60 (NDC 0173-0135-55) tablets. WELLBUTRIN SR Sustained-Release Tablets, 200 mg of bupropion hydrochloride, are light pink, round, biconvex, film-coated tablets printed with “WELLBUTRIN SR 200” in bottles of 60 (NDC 0173-0722-00) tablets. Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Dispense in
a tight, light-resistant container as defined in the USP.
WELLBUTRIN SR® (WELL byu-trin) (bupropion hydrochloride) Sustained-Release Tablets Read this Medication Guide carefully before you start using WELLBUTRIN SR and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about WELLBUTRIN SR, ask your doctor or pharmacist. 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?”
NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 57 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. Talk to your, or your family member’s, healthcare
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant medicines,
depression and other serious mental illnesses, and suicidal thoughts or actions?
4. Antidepressant medicines may increase suicidal thoughts or actions in some children,
teenagers, and young adults within the first few months of treatment.
5. Depression and 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.
6. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family
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 the healthcare provider right away to report new or sudden changes in mood, behavior, Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a 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:
• acting aggressive, being angry, or violent • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?
NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 58 • 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. • Not all antidepressant medicines prescribed for children are FDA approved for use in
children. Talk to your child’s healthcare provider for more information.
WELLBUTRIN SR has not been studied in children under the age of 18 and is not approved for use in children and teenagers. 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 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. Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion. If you, your family member, or your caregiver notice agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking bupropion and call your healthcare provider right away: • an extreme increase in activity and talking (mania) • seeing or hearing things that are not there • feeling people are against you (paranoia) • acting aggressive, being angry, or violent • other unusual changes in behavior or mood NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 59 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, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or 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. Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illnesses. You should also tell your doctor 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 WELLBUTRIN SR?
Seizures: There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN SR,
especially in people:
• with certain medical problems. • who take certain medicines. The chance of having seizures increases with higher doses of WELLBUTRIN SR. For more
information, see the sections “Who should not take WELLBUTRIN SR?” and “What should I
tell my doctor before using WELLBUTRIN SR?” Tell your doctor about all of your medical
conditions and all the medicines you take. Do not take any other medicines while you are
using WELLBUTRIN SR unless your doctor has said it is okay to take them.
If you have a seizure while taking WELLBUTRIN SR, stop taking the tablets and call
your doctor right away. Do not take WELLBUTRIN SR again if you have a seizure.
• High blood pressure (hypertension). Some people get high blood pressure, that can be
severe, while taking WELLBUTRIN SR. 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.
• Severe allergic reactions. Some people have severe allergic reaction to
WELLBUTRIN SR. Stop taking WELLBUTRIN SR and call your doctor right away if
you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around
NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 60 the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. • Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while
taking WELLBUTRIN SR, 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 doctor. What is WELLBUTRIN SR?
WELLBUTRIN SR is a prescription medicine used to treat adults with a certain type of depression
called major depressive disorder.
Who should not take WELLBUTRIN SR?
Do not take WELLBUTRIN SR if you
• have or had a seizure disorder or epilepsy.
• are taking ZYBAN® (used to help people stop smoking) or any other medicines that
contain bupropion hydrochloride, such as WELLBUTRIN® Tablets or WELLBUTRIN
XL® Extended-Release Tablets. Bupropion is the same active ingredient that is in
• drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden. • have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL®*(phenelzine sulfate), PARNATE®(tranylcypromine sulfate), or MARPLAN®*(isocarboxazid). • have or had an eating disorder such as anorexia nervosa or bulimia. • are allergic to the active ingredient in WELLBUTRIN SR, bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in WELLBUTRIN SR. What should I tell my doctor before using WELLBUTRIN SR?
Tell your doctor 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.”
a. Tell your doctor about your other medical conditions including if you:
• are pregnant or plan to become pregnant. It is not known if WELLBUTRIN SR can
• are breastfeeding. WELLBUTRIN SR passes through your milk. It is not known if
• have liver problems, especially cirrhosis of the liver.
• have kidney problems.
NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 61 • have 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 a lot of alcohol. • abuse prescription medicines or street drugs. • Tell your doctor about all the medicines you take, including prescription and non
prescription 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 using WELLBUTRIN SR. How should I take WELLBUTRIN SR?
• Take WELLBUTRIN SR exactly as prescribed by your doctor.
• Do not chew, cut, or crush WELLBUTRIN SR Tablets. You must swallow the tablets
whole. Tell your doctor if you cannot swallow medicine tablets.
• Take WELLBUTRIN SR at the same time each day. • Take your doses of WELLBUTRIN SR at least 8 hours apart. • You may take WELLBUTRIN SR with or without food. • If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time. This is very important. Too much WELLBUTRIN SR can
increase your chance of having a seizure.
• If you take too much WELLBUTRIN SR, or overdose, call your local emergency room or • Do not take any other medicines while using WELLBUTRIN SR unless your doctor has
told you it is okay.
• It may take several weeks for you to feel that WELLBUTRIN SR is working. Once you feel better, it is important to keep taking WELLBUTRIN SR exactly as directed by your doctor. Call your doctor if you do not feel WELLBUTRIN SR is working for you. • Do not change your dose or stop taking WELLBUTRIN SR without talking with your doctor What should I avoid while taking WELLBUTRIN SR?
• Do not drink a lot of alcohol while taking WELLBUTRIN SR. If you usually drink a lot of
alcohol, talk with your doctor 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 WELLBUTRIN SR affects you. WELLBUTRIN SR can impair your ability to perform these tasks. NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 62 What are possible side effects of WELLBUTRIN SR?
WELLBUTRIN SR can cause serious side effects. Read this entire Medication Guide for more
information about these serious side effects.
The most common side effects of WELLBUTRIN SR are loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often. If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. These are not all the side effects of WELLBUTRIN SR. For a complete list, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store WELLBUTRIN SR?
• Store WELLBUTRIN SR at room temperature. Store out of direct sunlight. Keep
WELLBUTRIN SR in its tightly closed bottle. • WELLBUTRIN SR tablets may have an odor. General Information about 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. Keep WELLBUTRIN SR out of the reach of children.
This Medication Guide summarizes important information about WELLBUTRIN SR. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about WELLBUTRIN SR that is written for health professionals. 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. 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. WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, ZYBAN, and PARNATE are registered *The following are registered trademarks of their respective manufacturers: NARDIL®/Warner Lambert Company; MARPLAN®/Oxford Pharmaceutical Services, Inc. This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709 Manufactured by: GlaxoSmithKline Research Triangle Park, NC 27709 or DSM Pharmaceuticals, Inc. Greenville, NC 27834 NDA 18-644/S-039 NDA 18-644/S-040 NDA 20-358/S-046 NDA 20-358/S-047 Page 64 2009, GlaxoSmithKline. All rights reserved.
SON Number: ERSON-09-04 November 8, 2007 STRATEGIC ENVIRONMENTAL RESEARCH AND DEVELOPMENT PROGRAM ENVIRONMENTAL RESTORATION (ER) FOCUS AREA FY 2009 STATEMENT OF NEED IMPROVED UNDERSTANDING OF THE FATE AND TRANSPORT OF MUNITIONS CONSTITUENTS ON OPERATIONAL RANGES 1. OBJECTIVE OF PROPOSED WORK The objective of this Statement of Need (SON) is to solicit fundamental and