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Wellbutrin Xl (Bupropion Hcl Xl)

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Wellbutrin XL (Bupropion HCL XL)

What is Wellbutrin XL? Wellbutrin, also known by the trade name bupropion, is an antidepressant medication. The XL version is an extended-release formula and is usually taken once daily. Wellbutrin XL is often used to treat seasonal affective disorder, a form of depression occurring during the fall and winter months. It's also a standard treatment for major depression (MDD) in adults. The full effects of the medication may not be felt for up to four weeks. Doctors typically start patients on low doses of the medication and increase it until the ideal dosage is achieved. When stopping Wellbutrin XL, doctors may taper doses downward for two weeks before complete termination.

Important Information Before Use:

  • Wellbutrin is not approved for use in people younger than 18.
  • Tell your doctor about all of your medication allergies. Additionally, tell your doctor and pharmacist which prescription and nonprescription drugs you currently take. Even herbal products like St. John's Wort can lead to unwanted drug interactions.
  • Wellbutrin, like many antidepressants, can have a dangerous interaction with a class of drugs called monoamine oxidase inhibitors (MAOIs). If you currently take an MAOI or have stopped taking one within the last 2 weeks, your doctor will likely not prescribe Wellbutrin. Examples of these drugs include Marplan (isocarboxazid), Nardil (phenelzine), and Emsam (selegiline).
  • If you have substance abuse problems, talk to your doctor before taking Wellbutrin.
  • Talk with your doctor about your medical history. Your doctor will need to know if you have ever had a heart attack, head injury, brain or spine tumor, high blood pressure, diabetes, or heart disease.
  • Alcohol can increase the side effects of Wellbutrin, particularly drowsiness.
  • Although Wellbutrin XL is not specifically approved to help with smoking cessation, people who have taken Zyban (Wellbutrin) have experienced psychiatric symptoms such as anger, paranoia, hallucinations, and hostility.

Important Information During Use:

  • Let your doctor know if you are breastfeeding, pregnant, or plan to become pregnant.
  • Be mindful of worsening depression or thoughts of suicide. There is a small risk of suicide or self-harm with any antidepressant.
  • Take Wellbutrin exactly as prescribed. Don't double up in the event of a skipped dose, and don't take more than your prescribed dosage. Don't chew or crush the tablets because this causes the drug to be released too quickly.
  • Taking Wellbutrin with food will prevent stomach upset.
  • You may see something that looks like a tablet in your stool. This is actually the empty casing for the medicine and doesn't mean that you didn't get your dosage.

Wellbutrin XL Side Effects

Serious:

  • Seizures
  • Confusion
  • Hallucinations
  • Irrational fears
  • Fever
  • Rash, blisters, or hives
  • Itching
  • Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • Hoarse voice
  • Trouble breathing or swallowing
  • Chest pain
  • Muscle or joint pain
  • Rapid, pounding, or irregular heartbeat

Less Serious:

  • Drowsiness
  • Excitement
  • Dry mouth
  • Dizziness
  • Headache
  • Nausea or vomiting
  • Weight loss
  • Constipation
  • Excessive sweating

Withdrawing:

Withdrawal from Wellbutrin is usually not considered serious. Gradual tapering of the dose minimizes any withdrawal effects while allowing faster reinstatement of the medication should symptoms of depression return.

Possible Symptoms of Wellbutrin Withdrawal:

  • Nausea or vomiting
  • Intense and frequent dreams
  • Headache
  • Vertigo
  • Changes to senses and perception
  • Numbness of extremities

Source:

GoodTherapy.org

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Update: Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies
Drug Safety and Availability
Postmarket Drug Safety Information for Patients and Providers

Drug Safety and Availability

Postmarket Drug Safety Information for Patients and Providers

Index to Drug-Specific Information
Approved Risk Evaluation and Mitigation Strategies (REMS)

Drug Safety Information for Healthcare Professionals

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Update: Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies

FDA’s update on this issue is an activity that is funded under FDA’s user fee program in the Center for Drug Evaluation and Research (CDER). Some FDA activities that do not rely on annual appropriations are continuing during the government shutdown.

[10-10-2013] FDA is providing an update on its request for studies to assess the bioequivalence of marketed bupropion hydrochloride (HCl) extended-release (ER) 300 mg tablets. We have completed our review of the studies from all four manufacturers of bupropion HCl ER 300 mg products currently on the market: Actavis, Inc.,* Mylan Inc., Par Pharmaceutical (formerly Anchen Pharmaceuticals), and Watson.*

Data submitted by Actavis, Inc., Mylan Inc., and Par Pharmaceutical confirmed that their generic bupropion HCl ER 300 mg tablet products are therapeutically equivalent to the reference-listed drug, Wellbutrin XL 300 mg. Patients can have confidence that these generics will have the same clinical effect and safety as the brand name drug.

Based on data submitted by Watson, FDA has determined that that company’s generic bupropion HCl ER 300 mg tablet product is not therapeutically equivalent to Wellbutrin XL 300 mg. Watson has agreed to voluntarily withdraw this product from the distribution chain. Also, FDA has changed the Therapeutic Equivalence Code for the Watson product from AB (therapeutically equivalent) to BX (data are insufficient to determine therapeutic equivalence) in the Orange Book. FDA does not anticipate a drug shortage.

We recommend that patients taking the Watson product continue taking their medication and contact their health care professional or pharmacist to address any concerns.

*Note that Actavis and Watson recently merged.

FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg

[10-3-2012] The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to Wellbutrin XL 300 mg. FDA has changed the therapeutic equivalence rating for this product in the Agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) from AB to BX, signifying that Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg. Impax has requested that the Agency withdraw approval of budeprion XL 300 mg extended-release tablets. Impax and Teva have stopped shipping the product and are issuing detailed information to their customers. This announcement relates only to Budeprion XL 300 mg manufactured by Impax and marketed by Teva. It does not affect the Impax/Teva Budeprion 150 mg product or generic bupropion products made by other manufacturers.

Background

FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product. This methodology was based on FDA’s guidance at the time the products were approved. FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.

The Impax/Teva product, Budeprion XL 300 mg, was approved in December 2006. Soon after, FDA began to receive reports that patients who were switched from Wellbutrin XL 300 mg to its generic counterparts were experiencing reduced efficacy. FDA analyzed those reports and concluded that the complaints appeared to be linked to the Impax/Teva product. FDA therefore asked Impax/Teva to conduct a study directly on its 300 mg extended-release product to compare its bioequivalence to Wellbutrin XL 300 mg. FDA asked that the study include patients who had reported lack of efficacy after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg. Impax/Teva began the study, but terminated it in late 2011, reporting that, despite efforts to enroll patients, Impax/Teva was unable to recruit a significant number of affected patients to generate the necessary data.

In 2010, in light of the public health interest in obtaining bioequivalence data, FDA decided to sponsor a bioequivalence study comparing Budeprion XL 300 mg to Wellbutrin XL 300 mg. This study was conducted in 24 healthy adult volunteers and was designed to measure both the rate and the extent of release of bupropion into the blood. The results of this study became available in August 2012, and show that Budeprion XL 300 mg tablets fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg.

FDA has not identified any new safety information associated with Budeprion XL 300 mg; however, in some patients, the drug may not provide the desired efficacy (beneficial effect).

FDA did not conduct bioequivalence studies of the other four generic versions of Wellbutrin XL 300 mg. FDA did, however, recently ask each of the other manufacturers – Anchen, Actavis, Watson, and Mylan – to conduct their own studies to assess the bioequivalence of their 300 mg extended-release bupropion tablets to Wellbutrin XL 300 mg. FDA has asked these companies to submit the data from those studies no later than March 2013. FDA believes the study results may be unique to the Impax/Teva version of 300 mg bupropion hydrochloride. FDA does not currently have data indicating that the other four generic products are not bioequivalent to Wellbutrin XL 300 mg. The Agency will review the data from the additional bioequivalence studies when the data are received, and will provide additional updates at that time.

Conclusion

Budeprion XL 300 mg tablets manufactured by Impax and marketed by Teva are not therapeutically equivalent to Wellbutrin XL 300 mg and will be removed from the market by Impax/Teva. FDA’s actions with respect to Budeprion XL 300 mg reflect FDA’s ongoing role in monitoring drugs on the market to ensure their continued safety and efficacy. The role of patients and health care professionals in sharing their experiences with generic versions of Wellbutrin XL 300 mg contributed to further studies, which led to this action. FDA remains firmly committed to its science-based responsibilities and to making sure that generic drugs are safe and effective. This commitment is reflected in the results of the FDA-sponsored bioequivalence study described above.

Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should talk with their health care professionals if they have questions about taking this medication.
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Page Last Updated: 10/11/2013

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA

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