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BUDEPRION SR- bupropion hydrochloride tablet, extended release


  1. Patient Information
  2. 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 (sr)?
  3. Talk To Your, Or Your Family Members, Healthcare Provider About:
  4. What Is The Most Important Information I Should Know About Antidepressant Medicines, Depression And Other Serious Mental Illnesses, And Suicidal Thoughts Or Actions?
  5. 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:
  6. What Else Do I Need To Know About Antidepressant Medicines?
  7. 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:
  8. Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release Tablets (sr), Especially In People:
  9. Do Not Take Bupropion Hydrochloride Extended-release Tablets (sr) If You:
  10. What Should I Avoid While Taking Bupropion Hydrochloride Extended-release Tablets (sr)?
  11. What Are Possible Side Effects Of Bupropion Hydrochloride Extended-release Tablets (sr)?
  12. How Should I Store Bupropion Hydrochloride Extended-release Tablets (sr)?
  13. What Are The Ingredients In Bupropion Hydrochloride Extended-release Tablets (sr)?
  14. Revised: 5/2015document Id:

Patient Information 

BUDEPRION SR
(buPROPion HCl Extended-Release Tablets)

Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (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 Bupropion Hydrochloride Extended-release Tablets (sr)? 

"

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 Members, Healthcare Provider About: 

  • 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? 

  • 1.Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • 2.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.

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: 

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • 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? 

  • 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.

Bupropion hydrochloride extended-release tablets (SR) have 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 bupropion hydrochloride extended-release tablets (SR) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBANwhich 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: 

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • panic attacks
  • feeling very agitated or restless
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • abnormal thoughts or sensations

Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release Tablets (sr), Especially In People: 

The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (SR). For more information,

Bupropion hydrochloride extended-release tablets (SR) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Do Not Take Bupropion Hydrochloride Extended-release Tablets (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 WELLBUTRINTablets or WELLBUTRIN XLExtended-Release Tablets.Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (SR).
  • 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 bupropion hydrochloride extended-release tablets (SR), bupropion, or to any of the inactive ingredients.

    Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems.

    • Take bupropion hydrochloride extended-release tablets (SR) exactly as prescribed by your doctor.
    • Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (SR).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. You must swallow the tablets whole.Tell your doctor if you cannot swallow medicine tablets.
    • Take bupropion hydrochloride extended-release tablets (SR) at the same time each day.
    • Take your doses of bupropion hydrochloride extended-release tablets (SR) at least 8 hours apart.
    • You may take bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (SR) can increase your chance of having a seizure.
    • If you take too much bupropion hydrochloride extended-release tablets (SR), or overdose, call your local emergency room or poison control center right away.
    • Do not take any other medicines while using bupropion hydrochloride extended-release tablets (SR) unless your doctor has told you it is okay.
    • It may take several weeks for you to feel that bupropion hydrochloride extended-release tablets (SR) are working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (SR) exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride extended-release tablets (SR) are working for you.
    • Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (SR) without talking with your doctor first.

What Should I Avoid While Taking Bupropion Hydrochloride Extended-release Tablets (sr)? 

  • Do not drink a lot of alcohol while taking bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (SR) affect you. Bupropion hydrochloride extended-release tablets (SR) can impair your ability to perform these tasks.

What Are Possible Side Effects Of Bupropion Hydrochloride Extended-release Tablets (sr)? 

Bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (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 Bupropion Hydrochloride Extended-release Tablets (sr)? 

  • Store bupropion hydrochloride extended-release tablets (SR) at room temperature. Store out of direct sunlight. Keep bupropion hydrochloride extended-release tablets (SR) in its tightly closed bottle.
  • Bupropion hydrochloride extended-release tablets (SR) may have an odor.

General Information about bupropion hydrochloride extended-release tablets (SR).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (SR) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (SR) to other people, even if they have the same symptoms you have. It may harm them. Keep bupropion hydrochloride extended-release tablets (SR) out of the reach of children.

This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for health professionals.

What Are The Ingredients In Bupropion Hydrochloride Extended-release Tablets (sr)? 

Active ingredient: bupropion hydrochloride.

Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose. The 100 mg tablet also contains FD&C Red No. 40, FD&C Yellow No. 5, hypromellose, iron oxide yellow, macrogol, polydextrose, titanium dioxide and triacetin. The 150 mg tablet also contains hypromellose, iron oxide yellow, macrogol, polydextrose, titanium dioxide and triacetin.

The 100 mg strength of this product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin sensitivity.

Rx only

ZYBAN, WELLBUTRIN, WELLBUTRIN XL, and PARNATEare registered trademarks of GlaxoSmithKline.
NARDILis a registered trademark of Warner Lambert Company.
MARPLANis a registered trademark of Oxford Pharmaceutical Services, Inc.
KALETRAis a registered trademark of Abbott Laboratories.

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

Manufactured By:
IMPAX Laboratories, Inc.
Hayward, CA 94544 USA

Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

Rev. 06/2010
514-05

Bupropion HCl 150mg SR Tablet

Label
BUDEPRION SR
bupropion hydrochloride tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-2873(NDC:0093-5502)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (TYPE E)(UNII: 66O7AQV0RT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYDEXTROSE(UNII: VH2XOU12IE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
ColorYELLOW (light yellow)Scoreno score
ShapeROUNDSize7mm
FlavorImprint CodeG;2444
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-2873-160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63629-2873-290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:63629-2873-330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:63629-2873-4120 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:63629-2873-545 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:63629-2873-6180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07591303/23/2004
Labeler -Bryant Ranch Prepack (171714327)
Registrant -Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-2873) , RELABEL(63629-2873)

Revised: 5/2015document Id: 

763ec70c-b853-4664-a648-74046636e1b2Set id: c3ce7349-8ef2-4e66-a7d7-24fe71d18866Version: 1001Effective Time: 20150504Bryant Ranch Prepack



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