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USP DI Vol. II - BUPROPION (Systemic)

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
  • Smokingcessation adjunct

Description

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

Bupropion is sold under different brand names for different uses. If youare 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 prescriptionfor bupropion at a time.

This medicine is available only with your doctor's prescription, in thefollowing 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 willdo. This is a decision you and your doctor will make. For bupropion, the followingshould be considered:

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

Pregnancy?Studies have not been done in pregnant women. Bupropionhas 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 pregnantor if you may become pregnant.

Breast-feeding?Bupropion passes into breast milk. Because it maycause unwanted effects in nursing babies, use of bupropion is not recommendedduring breast-feeding.

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

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingbupropion, it is especially important that your health care professional knowif 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 bupropionmay 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 anMAO inhibitor or you may increase the chance of serious side effects;at least 14 days should be allowed between stopping treatment with an MAOinhibitor and starting treatment with bupropion

Other medical problems?The presence of other medicalproblems may affect the use of bupropion. Make sure you tell your doctor ifyou 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 thatmakes you sleepy) or benzodiazepines (alprazolam [e.g., Xanax], diazepam [e.g.,Valium], triazolam [e.g., Restoril])?The risk of seizures may be increasedwhen 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 doctorordered. To do so may increase the chance of side effects.

For patients taking the prompt-release tablet formof this medicine

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

For patients taking the sustained-release tablet formof 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 formof 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 yourdoctor 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 youfeel better. Your doctor should check your progress at regular visits.
  • You will probably need to keep taking bupropion for at least 6 monthsto help prevent the return of the depression.

Dosing?The dose of bupropion will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 timeallowed between doses, and the length of time you take the medicine dependon 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 isnot 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 isnot 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 increaseyour dose as needed. However, the dose usually is not more than 150 mg twotimes 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 increaseyour dose as needed. However, the dose usually is not more than 150 mg threetimes a day.
      • Children?Use and dose must be determined by your doctor.

Missed dose?If you are taking the extended-release or the prompt-releaseform of this medicine and you miss a dose, skip the missed dose and go backto 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 otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Yourdoctor should check your progress at regular visits, especially during thefirst few months of treatment with this medicine. The amount of bupropionyou take may have to be changed often to meet the needs of your conditionand to help avoid unwanted effects.

Do not take bupropion within 14 days of taking an MAOinhibitor.

Bupropion may cause some people to be agitated, irritable or display otherabnormal behaviors. It may also cause some people to have suicidal thoughtsand tendencies or to become more depressed. If you or your caregiver noticeany of these adverse effects, tell your doctor right away.

Bupropion is sold under different brand names for different uses. If youare 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 prescriptionfor 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 alertand clearheaded.


Side Effects of This Medicine

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

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

    More common

      Agitation; anxiety

    Less common

      Buzzing or ringing in ears; headache(severe); skin rash, hives, or itching

    Rare

      Confusion; extreme distrust; fainting; false beliefs that cannotbe changed by facts; hallucinations (seeing, hearing,or feeling things that are not there); seizures (convulsions),especially with higher doses; trouble in concentrating

    Incidence not determined

      Actions that are out of control; anger; assault; attack; being impulsive; chest pain or discomfort; fast or pounding heartbeat; force; inability to sit still; irritability; need to keep moving; nervousness; restlessness; sweating; talking, feeling, and acting with excitement

    Symptoms of overdose?may be more severe than side effects seen at regulardoses, or two or more may occur together

      Fast heartbeat; hallucinations (seeing, hearing,or feeling things that are not there); loss of consciousness; nausea; seizures (convulsions); vomiting

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

    More common

      Abdominal pain; constipation; decrease in appetite; dizziness; dryness of mouth; increased sweating; nausea or vomiting; tremblingor shaking; trouble in sleeping; weight loss (unusual)

    Less common

      Blurred vision; change in sense of taste; drowsiness; feeling offast or irregular heartbeat; frequent need to urinate; muscle pain; sore throat; unusual feeling of well-being

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


Revised: 01/07/2005