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|Wellbutrin SR

BUPROPION (Systemic)

Some commonly used brand names are:

In the U.S.—

• Wellbutrin
• Wellbutrin SR
• Wellbutrin XL
• Zyban

In Canada—

• Wellbutrin SR
• Zyban

Another commonly used name is amfebutamone .

Category

• Antidepressant
• Smoking cessation adjunct

Description

Bupropion (byoo-PROE-pee-on) is used to relieve mental depression and is used as part of a support program to help you stop smoking.

Bupropion is sold under different brand names for different uses. If you are already taking medicine for mental depression or to help you stop smoking, discuss this with your health care professional before taking bupropion. It is very important that you receive only one prescription for bupropion at a time .

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Extended-release tablets (U.S.)
• Sustained-release tablets (U.S. and Canada)
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bupropion, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bupropion. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. Bupropion has not been reported to cause birth defects or other problems in animal studies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Bupropion passes into breast milk. Because it may cause unwanted effects in nursing babies, use of bupropion is not recommended during breast-feeding.

Children—Bupropion must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure venlafaxine is safe and effective in children

Older adults—This medicine has been tested in a limited number of patients 60 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking bupropion, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Antipsychotics (medicine for mental illness) or
• Corticosteroids (cortisone-like medicine) or
• Fluoxetine (e.g., Prozac) or
• Lithium (e.g., Lithane) or
• Maprotiline (e.g., Ludiomil) or
• Theophylline (e.g., Somophyllin-T) or
• Trazodone (e.g., Desyrel) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or
• Ritonavir (e.g., Norvir)—Using these medicines with bupropion may increase the risk of seizures

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take bupropion while you are taking or within 14 days of taking an MAO inhibitor or you may increase the chance of serious side effects; at least 14 days should be allowed between stopping treatment with an MAO inhibitor and starting treatment with bupropion

Other medical problems—The presence of other medical problems may affect the use of bupropion. Make sure you tell your doctor if you have any other medical problems, especially:

• Anorexia nervosa, or history of or
• Brain tumor or
• Bulimia, or history of or
• Drug abuse or
• Head injury, history of or
• Mental retardation or
• Seizure disorders
• Sudden stop in drinking alcohol or using sedatives (medicine that makes you sleepy) or benzodiazepines (alprazolam [e.g., Xanax], diazepam [e.g., Valium], triazolam [e.g., Restoril])—The risk of seizures may be increased when bupropion is taken by patients with these conditions

• Bipolar disorder (manic-depressive illness) or risk of or
• Other nervous, mental, or emotional conditions or
• High blood pressure—Bupropion may make the condition worse

• Heart disease—Higher blood levels of bupropion may result, increasing the chance of side effects, or blood pressure may be increased

• Kidney disease or
• Liver disease—Higher blood levels of bupropion may result, increasing the chance of side effects

Proper Use of This Medicine

Use bupropion only as directed by your doctor . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

For patients taking the prompt-release tablet form of this medicine

• Take doses at least 4 hours apart to decrease the chance of seizures.

For patients taking the sustained-release tablet form of this medicine

• Take doses at least 8 hours apart to decrease the chance of seizures.
• Swallow tablets whole. Do not crush, break, or chew them.

For patients taking the extended-release tablet form of this medicine

• Take doses at least 24 hours apart to decrease the chance of seizures.
• Swallow tablets whole. Do not crush, break, or chew them.

To lessen stomach upset, this medicine may be taken with food, unless your doctor has told you to take it on an empty stomach.

For patients taking this medicine for mental depression

• Usually this medicine must be taken for several weeks before you feel better. Your doctor should check your progress at regular visits.
• You will probably need to keep taking bupropion for at least 6 months to help prevent the return of the depression.

Dosing—The dose of bupropion will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of bupropion. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking bupropion .

• For oral extended-release dosage form (tablets):
  • For mental depression:
    • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 450 mg one time a day.
    • Children—Use and dose must be determined by your doctor.

• For oral sustained-release dosage form (tablets):
  • For mental depression:
    • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 200 mg two times a day.
    • Children—Use and dose must be determined by your doctor.
  • To help you stop smoking:
    • Adults—At first, 150 mg once a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 150 mg two times a day.
    • Children—Use and dose must be determined by your doctor.

• For oral prompt-release dosage form (tablets):
  • For mental depression:
    • Adults—At first, 100 mg two times a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 150 mg three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you are taking the extended-release or the prompt-release form of this medicine and you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. The amount of bupropion you take may have to be changed often to meet the needs of your condition and to help avoid unwanted effects.

Do not take bupropion within 14 days of taking an MAO inhibitor .

Bupropion may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Bupropion is sold under different brand names for different uses. If you are already taking medicine for mental depression or to help you stop smoking, discuss this with your health care professional before taking bupropion. It is very important that you receive only one prescription for bupropion at a time .

Drinking of alcoholic beverages should be limited or avoided, if possible, while taking bupropion. This will help prevent seizures.

This medicine may cause some people to feel a false sense of well-being, or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur :

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 01/07/2005

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