Pronunciation:

bue-PROE-pee-on

Brand Names:

• Budeprion SR
• Budeprion XL
• Buproban
• Wellbutrin
• Wellbutrin SR
• Wellbutrin XL
• Zyban

Dosage Forms:

• Tablet, Extended Release, 24 HR
• Tablet, Extended Release, 12 HR
• Tablet
• Tablet, Extended Release

Warnings:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of bupropion or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Bupropion is not approved for use in pediatric patients .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Classifications:

Therapeutic—

Antidepressant

Chemical—

Aminoketone

Uses of This Medicine:

Bupropion is used to treat mental depression. It is also used as part of a support program to help people stop smoking. This medicine may also be used to prevent depression in patients with seasonal affective disorder, which is sometimes called winter depression .

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 doctor 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 .

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bupropion in the pediatric population. Studies with other medicines used for depression have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking these medicines. Because of this toxicity, use in children is not recommended .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of bupropion in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving bupropion .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Selegiline
• Toloxatone
• Tranylcypromine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

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

• Alcohol use, if stopped suddenly, or
• Anorexia nervosa, or history of, or
• Bulimia, or history of, or
• Sedative (sleeping medicine) use, if stopped suddenly (e.g., alprazolam [Xanax®], diazepam [Valium®], triazolam [Restoril®]), or
• Seizures (convulsions), or history of—Should not use in patients with these conditions .

• Bipolar disorder (mental disease with cycles of elation and depression), or history of, or
• High blood pressure or
• Psychosis (mental disease that affects emotions and behaviors)—May make these conditions worse .

• Brain tumor or
• Diabetes or
• Drug or alcohol abuse (e.g., opiates, cocaine, stimulants) or
• Head injury, history of or
• Liver cirrhosis, severe—The risk of seizures may be increased when bupropion is taken by patients with these conditions .

• Heart attack, recent or
• Heart disease—May cause side effects to become worse .

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

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 the 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 the tablets whole. Do not crush, break, or chew them.
• If you use this medicine to prevent depression in seasonal affective disorder, take it during the autumn season before your symptoms start. Continue using this medicine through the winter season and until early spring .

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:

• This medicine must be taken for several weeks, usually 4 weeks, before you start to feel better. You will probably need to keep taking bupropion for several months to help prevent the return of your depression. Your doctor will check your progress at regular visits, especially during the first few weeks that you take this medicine .
• You should take this medicine at the same time each day .

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

• 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 once a day.
    • Children—Use and dose must be determined by your doctor .
  • For seasonal affective disorder:
    • 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 300 mg once 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 milligrams (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 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg three times a day.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 .

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

Do not take bupropion with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking bupropion. If you do, you might have convulsions (seizures) .

Your blood pressure might get too high while you are using this medicine. This may cause headaches, blurred vision, and other symptoms. You might need to measure your blood pressure at home. If you think your blood pressure is getting too high, call your doctor right away .

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, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away .

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you take this medicine .

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

This medicine may cause some people to have 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 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 immediately 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

fainting

false beliefs that cannot be changed by facts

hallucinations

having extreme distrust of people

seeing, hearing, or feeling things that are not there

seizures (convulsions)

trouble with concentrating

Incidence not known

Actions that are out of control

anger

assaulting others

attacking others

being aggressive

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, or acting with excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

Fast heartbeat

hallucinations

loss of consciousness

nausea

seeing, hearing, or feeling things that are not there

seizures (convulsions)

vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain

constipation

decrease in appetite

dizziness

dry mouth

increased sweating

nausea or vomiting

trembling or shaking

trouble with sleeping

weight loss (unusual)

Less common

Blurred vision

change in sense of taste

drowsiness

feeling of fast or irregular heartbeat

frequent need to urinate

muscle pain

sore throat

unusual feeling of well-being

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