Generic Name: bupropion (Oral route)
Suicidality and Antidepressant Drugs
Use in Treating Psychiatric Disorders: Although Zyban(R) is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications Wellbutrin(R), Wellbutrin SR(R), and Wellbutrin XL(R). 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 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.
Use in Smoking Cessation Treatment: Wellbutrin(R), Wellbutrin SR(R), and Wellbutrin XL(R) are not approved for smoking cessation treatment, but bupropion under the name Zyban(R) is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.
All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking bupropion in the postmarketing experience. When symptoms were reported, most were during treatment with bupropion, but some were following discontinuation of treatment with bupropion.
These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of bupropion.
Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of bupropion was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.
The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. Bupropion has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial .
Wellbutrin(R): 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.
Zyban(R): Serious neuropsychiatric events, including depression, suicidal ideation, suicide attempt, and completed suicide, have been reported in patients with and without pre-existing psychiatric disease who were taking bupropion for smoking cessation; some experienced worsening of their psychiatric illnesses. All patients should be observed for changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. The patient should stop taking bupropion and contact a healthcare provider immediately if any neuropsychiatric behavior that is not typical for the patient is observed, or if the patient develops suicidal ideation or suicidal behavior. This risk should be weighed against the benefits of its use.
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidepressant
Chemical Class: Aminoketone
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.
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bupropion in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving bupropion.
|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.|
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.
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.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
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:
This section provides information on the proper use of a number of products that contain bupropion. It may not be specific to Budeprion SR. Please read with care.
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.
This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
Swallow the sustained-release tablets whole. Do not break, crush, or chew it.
You may take this medicine with or without food. But, if you have nausea, take this medicine with food.
If you are taking Zyban® tablets to help you stop smoking, you may continue to smoke for about 1 week after you start using this medicine. Then, you should set a target date to quit smoking during your second week of Zyban® treatment. Talk to your doctor if you are having trouble to stop smoking after you have used this medicine for at least 7 weeks.
Do not smoke if you are using a nicotine patch or any other medicine containing nicotine together with Zyban® tablets. To do so, may increase risk for more serious side effects.
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.
If you have trouble with sleeping (insomnia), do not take this medicine too close to bedtime.
For patients taking the extended-release tablet form of this medicine:
To lessen stomach upset, this medicine may be taken with food, unless your doctor has told you to take it on an empty stomach.
To help you remember to use your medicine, take it at the same time each day.
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.
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 tablets and you miss a dose, skip the missed dose and go back to your regular dosing schedule.
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.
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 inhibitor (MAOI) 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 right away.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and 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.
Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
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
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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