Bupropion Sustained-Release Tablets

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Bupropion Sustained-Release Tablets


Generic Name: Bupropion Sustained-Release Tablets (Smoking Deterrent) (bue-PROE-pee-on)
Brand Name: Zyban

Although Bupropion Sustained-Release Tablets is not used to treat depression, it contains the same ingredient that is in Wellbutrin, an antidepressant. Antidepressants may increase the risk of suicidal thoughts or actions in children and teenagers. The risk may be greater during the first few months that patients take Bupropion Sustained-Release Tablets. Be sure that the benefits of using Bupropion Sustained-Release Tablets outweigh the risks. Talk with the patient"s doctor if you have any questions.

Family and caregivers must closely observe patients who take Bupropion Sustained-Release Tablets. It is important to keep in close contact with the patient"s doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior.


Bupropion Sustained-Release Tablets is used for:

Helping certain patients to stop smoking cigarettes. It may also be used for other conditions as determined by your doctor.

Bupropion Sustained-Release Tablets is an antidepressant that has been found to aid in the stopping of smoking.

Do NOT use Bupropion Sustained-Release Tablets if:

  • you are allergic to any ingredient in Bupropion Sustained-Release Tablets
  • you are taking any other medicine that contains bupropion
  • you have a history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)
  • you are suddenly stopping the use of alcohol or sedatives (eg, benzodiazepines) after long-term use
  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bupropion Sustained-Release Tablets:

Some medical conditions may interact with Bupropion Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse
  • if you have diabetes, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), or a recent heart attack
  • if you have a history of seizure, head injury, tumor in the brain or spinal cord, or liver problems (eg, cirrhosis)

Some MEDICINES MAY INTERACT with Bupropion Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amantadine, antipsychotics (eg, haloperidol, risperidone), corticosteroids (eg, prednisone), insulin, levodopa, MAOIs (eg, phenelzine), nicotine patches, oral hypoglycemics (eg, glipizide), other antidepressants (eg, fluoxetine, amitriptyline), sympathomimetics (eg, pseudoephedrine), theophylline, or tiagabine because they may increase the risk of Bupropion Sustained-Release Tablets"s side effects
  • Carbamazepine, phenobarbital, or phenytoin because they may decrease Bupropion Sustained-Release Tablets"s effectiveness
  • Antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine), or tricyclic antidepressants (eg, nortriptyline) because the risk of their side effects may be increased by Bupropion Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bupropion Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bupropion Sustained-Release Tablets:

Use Bupropion Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Bupropion Sustained-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Bupropion Sustained-Release Tablets refilled.
  • Take Bupropion Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow Bupropion Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
  • Several weeks may pass before your symptoms improve. Do not stop taking Bupropion Sustained-Release Tablets without checking with your doctor.
  • Take your doses at the same times each day at least 8 hours apart unless directed otherwise by your doctor. This may help to decrease the risk of seizures with Bupropion Sustained-Release Tablets.
  • It takes about 1 week for Bupropion Sustained-Release Tablets to work. You should begin taking Bupropion Sustained-Release Tablets while you are still smoking. However, you and your doctor should decide on a date that you will stop smoking during the 2nd week of taking Bupropion Sustained-Release Tablets.
  • If you have not made progress towards stopping smoking by the 12th week, contact your doctor.
  • If you are not able to stop smoking while using Bupropion Sustained-Release Tablets, talk to your doctor to determine why you were not successful. After the reasons have been reduced or eliminated, you should try to stop smoking again.
  • Continue to take Bupropion Sustained-Release Tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of Bupropion Sustained-Release Tablets, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bupropion Sustained-Release Tablets.

Important safety information:

  • Bupropion Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Bupropion Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Bupropion Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Bupropion Sustained-Release Tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you drink large amounts of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Bupropion Sustained-Release Tablets.
  • If you already drink alcohol or use sedatives, do not suddenly stop them without first checking with your doctor. Suddenly stopping them may increase your seizure risk.
  • Do not take decongestants (eg, pseudoephedrine), stimulants, or diet pills while you are taking Bupropion Sustained-Release Tablets without first checking with your doctor. They may increase your risk of seizures.
  • The risk of seizures may be greater if you take Bupropion Sustained-Release Tablets in high doses or for a long time. Do NOT take more than the recommended dose, change your dose, or use Bupropion Sustained-Release Tablets for longer than prescribed without checking with your doctor.
  • Children and teenagers who take Bupropion Sustained-Release Tablets may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Bupropion Sustained-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • If you have trouble sleeping, you may be taking your dose too close to bedtime. Talk with your doctor about changing your dosing schedule.
  • It is important to follow the program that your doctor has prescribed, including behavioral changes, counseling, or support services, in order to stop smoking.
  • Bupropion Sustained-Release Tablets can be used together with the nicotine skin patches only under the supervision of your doctor. Using these medicines together may raise your blood pressure. If you are already using a nicotine skin patch, your blood pressure should be checked regularly.
  • Do not smoke if you are using Bupropion Sustained-Release Tablets along with the nicotine skin patch or any nicotine product.
  • Stopping smoking may change the amount of certain medicines (eg, theophylline, warfarin) in your blood. Be sure your doctor knows all the medicines that you are taking.
  • Bupropion Sustained-Release Tablets contains the same ingredients as Wellbutrin, an antidepressant. Do not take Bupropion Sustained-Release Tablets if you are also taking Wellbutrin or other brands of bupropion. Discuss any questions or concerns with your doctor.
  • Use Bupropion Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
  • Bupropion Sustained-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bupropion Sustained-Release Tablets while you are pregnant. Bupropion Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Bupropion Sustained-Release Tablets.

Possible side effects of Bupropion Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; loss of appetite; nausea; nervousness; stomach pain; stuffy nose; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; concentration problems, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated sense of well-being, inability to sit still, or other unusual or severe mental or mood changes; confusion; changes in sexual desire or ability; delusions; fainting; fast or irregular heartbeat; fever or chills; hallucinations; hearing problems or ringing in the ears; joint or muscle pain; menstrual changes; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent anxiety, agitation, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; fast, slow, or irregular heartbeat; fever; hallucinations; loss of consciousness; rigid or painful muscles; seizures; severe dizziness; slow or difficult breathing.

Proper storage of Bupropion Sustained-Release Tablets:

Store Bupropion Sustained-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bupropion Sustained-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Bupropion Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Bupropion Sustained-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Bupropion Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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