"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complaine"...
- Clinician Information:
Budeprion XL Patient Information including How Should I Take
In this Article
- What is bupropion (Budeprion XL)?
- What are the possible side effects of bupropion?
- What is the most important information I should know about bupropion?
- What should I discuss with my healthcare provider before taking bupropion?
- How should I take bupropion?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking bupropion?
- What other drugs will affect bupropion?
- Where can I get more information?
What should I discuss with my healthcare provider before taking bupropion?
Do not take bupropion if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.
You should not take bupropion if you have:
- epilepsy or a seizure disorder;
- an eating disorder such as anorexia or bulimia;
- if you are using a second form of bupropion; or
- if you have suddenly stopped using alcohol or sedatives (such as Valium).
Bupropion may cause seizures, especially in people with certain medical conditions. Tell your doctor about all of your medical conditions.
To make sure you can safely take bupropion, tell your doctor if you have any of these other conditions:
- a history of head injury, seizures, or brain or spinal cord tumor;
- heart disease, high blood pressure, history of heart attack;
- kidney or liver disease (especially cirrhosis); or
- bipolar disorder (manic depression).
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category C. It is not known whether bupropion will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Bupropion passes into breast milk and could be harmful to a nursing baby. You should not breast-feed while you are taking bupropion.
How should I take bupropion?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Bupropion can be taken with or without food.
Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time, which could increase side effects including seizures.
If you take Zyban to help you stop smoking, you may continue to smoke for about 1 week after you start the medicine. Set a date to quit smoking during the second week of treatment. Talk to your doctor if you are having trouble quitting after you have used Zyban for at least 7 weeks.
Your doctor may prescribe nicotine patches or gum to help support your smoking cessation treatment. Be sure you read all directions and safety information for the nicotine product. Using nicotine with Zyban may raise your blood pressure and your doctor may want to check your blood pressure regularly. Do not smoke at any time if you are using a nicotine product along with Zyban. Too much nicotine can cause serious side effects.
Do not stop taking bupropion without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.
This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking bupropion.
Store at room temperature away from moisture and heat.
Additional Budeprion XL Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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