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APLENZIN ER- bupropion hydrobromide tablet, extended release


  1. Patient Information
  2. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  3. What Else Do I Need To Know About Antidepressant Medicines?
  4. What Other Important Information Should I Know About Aplenzin?
  5. Do Not Take Aplenzin If You:
  6. How Should I Take Aplenzin?
  7. What Should I Avoid While Taking Aplenzin?
  8. What Are Possible Side Effects Of Aplenzin?
  9. What Are The Ingredients In Aplenzin?
  10. Aplenzin Er 348 Mg Package Label:
  11. Revised: 2/2011document Id:

Patient Information 

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.
3.

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 the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • 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 providerright awayif 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.

Aplenzin has not been studied in children under the age of 18 and is not approved for use in children and teenagers.

What Other Important Information Should I Know About Aplenzin? 

There is a chance of having a seizure (convulsion, fit) with Aplenzin, especially in people:

  • with certain medical problems.
  • who take certain medicines.

The chance of having seizures increases with higher doses of Aplenzin. For more information,

Aplenzin is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Do Not Take Aplenzin 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, such as WELLBUTRINTablets, or WELLBUTRIN SRSustained-Release Tablets, or WELLBUTRIN XLExtended-Release Tablets.Bupropion is the same active ingredient that is in Aplenzin.
  • 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 Aplenzin, bupropion, or to any of the inactive ingredients.

    • Tell your doctor about your medical conditions. Tell your doctor if you:
      • are pregnant or plan to become pregnant.It is not known if Aplenzin can harm your unborn baby.
      • are breastfeeding. Aplenzin passes through your milk. It is not known if Aplenzin can harm your baby.
      • have liver problems, especially cirrhosis of the liver.
      • have kidney problems.
      • 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 Aplenzin.

How Should I Take Aplenzin? 

  • Take Aplenzin exactly as prescribed by your doctor.
  • Do not chew, cut, or crush Aplenzin tablets.You must swallow the tablets whole.Tell your doctor if you cannot swallow medicine tablets.
  • Take Aplenzin at the same time each day.
  • Take your doses of Aplenzin at least 24 hours apart.
  • You may take Aplenzin 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 Aplenzin can increase your chance of having a seizure.
  • If you take too much Aplenzin, or overdose, call your local emergency room or poison control center right away.
  • The Aplenzin tablet is covered by a shell that slowly releases the medicine inside your body. You may notice something in your stool that looks like a tablet. This is normal. This is the empty shell passing from your body.
  • Do not take any other medicines while using Aplenzin unless your doctor has told you it is okay.
  • If you are taking Aplenzin for the treatment of major depressive disorder, it may take several weeks for you to feel that Aplenzin is working. Once you feel better, it is important to keep taking Aplenzin exactly as directed by your doctor. Call your doctor if you do not feel Aplenzin is working for you.
  • Do not change your dose or stop taking Aplenzin without talking with your doctor first.

What Should I Avoid While Taking Aplenzin? 

  • Do not drink a lot of alcohol while taking Aplenzin. 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 Aplenzin affects you. Aplenzin can impair your ability to perform these tasks.

What Are Possible Side Effects Of Aplenzin? 

  • Seizures.Some patients may get seizures while taking Aplenzin.If you have a seizure while taking Aplenzin, stop taking the tablets and call your doctor right away.Do not take Aplenzin again if you have a seizure.
  • Hypertension (high blood pressure).Some patients may get high blood pressure, sometimes severe, while taking Aplenzin. The chance of high blood pressure may be increased if you also use nicotine replacement therapy (for example, a nicotine patch) to help you stop smoking.
  • Severe allergic reactions. Stop taking Aplenzin and call your doctor right awayif 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.
  • Unusual thoughts or behaviors.Some patients may have unusual thoughts or behaviors while taking Aplenzin, including delusions (believe you are someone else), hallucinations (

    • Store Aplenzin at room temperature. Store out of direct sunlight. Keep Aplenzin in its tightly closed bottle.
    • Aplenzin tablets may have an odor.

    General Information about Aplenzin.

    • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Aplenzin for a condition for which it was not prescribed. Do not give Aplenzin to other people, even if they have the same symptoms you have. It may harm them. Keep Aplenzin out of the reach of children.

    This Medication Guide summarizes important information about Aplenzin. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about Aplenzin that is written for health professionals or you can call toll-free [800-633-1610].

What Are The Ingredients In Aplenzin? 

Active ingredient: bupropion hydrobromide.

Inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths.The tablets are printed with edible black ink.

The following are registered trademarks of their respective manufacturers: WELLBUTRIN/GlaxoSmithKline, WELLBUTRIN SR/GlaxoSmithKline, WELLBUTRIN XL/GlaxoSmithKline, ZYBAN/GlaxoSmithKline; PROZAC/Eli Lilly and Company; ZOLOFT/Pfizer Pharmaceuticals; LUVOX/Solvay Pharmaceuticals, Inc.; ANAFRANIL/Mallinckrodt Inc.; NARDIL/Warner Lambert Company; MARPLAN/Oxford Pharmaceutical Services, Inc.

Rx only

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

LB0060-00
Rev. 10/08
50090346

Aplenzin Er 348 Mg Package Label: 

Label Image

APLENZIN ER
bupropion hydrobromide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:16590-922(NDC:0024-5811)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROBROMIDE(UNII: E70G3G5863) (BUPROPION - UNII:01ZG3TPX31)BUPROPION HYDROBROMIDE348 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
GLYCERYL BEHENATE(UNII: R8WTH25YS2)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Product Characteristics
Colorwhite (white to off-white)Scoreno score
ShapeROUNDSize8mm
FlavorImprint CodeBR;348
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16590-922-3030 in 1 BOTTLE
2NDC:16590-922-6060 in 1 BOTTLE
3NDC:16590-922-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02210803/30/2009
Labeler -STAT RX USA LLC (786036330)
Establishment
NameAddressID/FEIBusiness Operations
STAT RX USA LLC786036330relabel, repack

Revised: 2/2011document Id: 

13551a6c-64f2-45df-8b41-5c97b2c01421Set id: 2315d6e5-144d-4163-9711-f855c759cf8eVersion: 1Effective Time: 20110210STAT RX USA LLC



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