There is an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. Serious neuropsychiatric events have been reported in patients taking buPROPion for smoking cessation. Observe all patients for neuropsychiatric effects, even if they are not using buPROPion for smoking cessation .Oral route(Tablet, Extended Release;Tablet, Extended Release, 24 HR)
Forfivo(TM) XL: There is an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. Serious neuropsychiatric events have been reported in patients taking buPROPion for smoking cessation. Observe all patients for neuropsychiatric effects, even if they are not using buPROPion for smoking cessation .Zyban(R): Serious neuropsychiatric reactions have been reported in patients taking sustained-release buPROPion hydrochloride for smoking cessation. Weigh the risks of sustained-release buPROPion hydrochloride use against the benefits prior to use. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. There was a reduction in risk with antidepressants compared with placebo in adults aged 65 and older. Monitor for worsening of depression and for emergence of suicidal thoughts and behaviors .Oral route(Tablet, Extended Release)
Suicidal thinking and behavior in children, adolescents, and young adults have been reported with antidepressants. Monitor patients closely for clinical worsening and suicidal thoughts and behaviors; advise families and caregivers of the need for close observation and communication with the prescriber. BuPROPion hydrobromide is not approved for smoking cessation, but serious neuropsychiatric reactions have occurred during and after discontinuing treatment in patients taking buPROPion for smoking cessation. Observe all patients for neuropsychiatric reactions, and patients should contact a healthcare provider if such reactions occur .
Bupropion is used to treat depression and to prevent depression in patients with seasonal affective disorder (SAD), which is sometimes called winter depression. It is also used as part of a support program to help people stop smoking.
Bupropion is sold under different brand names. If you are already taking medicine for 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 at a time for bupropion.
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 potential unwanted effect, 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 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.
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 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.
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:
Take this medicine 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 tablet whole. Do not break, crush, divide, or chew it.
You may take this medicine with or without food. But if you have nausea, take the medicine with food.
A part of the extended-release tablet may pass into your stool. This is normal and is nothing to worry about.
Use of Zyban® tablets:
If you have trouble sleeping (insomnia), do not take this medicine too close to bedtime.
If you use this medicine to prevent depression with seasonal affective disorder, take it during the autumn season before your symptoms start. Continue using the medicine through the winter season and until early spring.
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 Wellbutrin XL® extended-release tablet 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.
Do not take bupropion with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking bupropion during the 2 weeks after you stop a MAO inhibitor, and wait 2 weeks after stopping bupropion before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may have confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.
Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is 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. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you 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. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.
Drinking alcoholic beverages should be limited or avoided, if possible, with bupropion. This will help prevent seizures.
This medicine may cause some people to have a false sense of wellbeing, 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 drowsy, dizzy, or less alert.
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 certain side effects when you stop the medicine, such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headaches, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause a change in your appetite or weight. Your doctor may need to check your weight on a regular basis.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this 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:
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:
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.