Wellbutrin XL

Wellbutrin XL is a prescription medication used to treat depression, seasonal depression, and to quit smoking, depending on the form. Wellbutrin XL belongs to a group of drugs called antidepressants, which work by affecting certain natural chemicals in the brain. It is not known how bupropion helps patients quit smoking.

This medication comes in as an extended-release tablet and is usually taken once daily, in the morning.

Common side effects of bupropion include nervousness, constipation, trouble sleeping, headache, and nausea.

Bupropion is a prescription medication used to treat depression and to quit smoking, depending on the form.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Valeant Pharmaceuticals International

The most common side effects of bupropion are:

• nervousness
• constipation
• trouble sleeping
• dry mouth
• headache
• nausea
• vomiting
• and shakiness (tremor)

If you have nausea, take your medicine with food.

Bupropion can cause serious side effects (see "Black Box Warning" and "Drug Precautions").

If you have trouble sleeping, do not take your medicine too close to bedtime. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• MAO inhibitors (isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate))
• amantadine (Symmetrel)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• cyclophosphamide (Cytoxan, Neosar)
• diet pills
• insulin or oral medications for diabetes
• medications for irregular heartbeat such as flecainide (Tambocor) and propafenone (Rythmol)
• medications for mental illness such as haloperidol (Haldol), risperidone (Risperdal), and thioridazine (Mellaril)
• medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin)
• levodopa (Sinemet, Larodopa)
• nicotine patch
• oral steroids such as dexamethasone (Decadron, Dexone)
• methylprednisolone (Medrol), and prednisone (Deltasone)
• orphenadrine (Norflex)
• other antidepressants such as desipramine (Norpramin), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), paroxetine (Paxil) and sertraline (Zoloft)
• sedatives
• sleeping pills
• theophylline (Theobid, Theo-Dur, others)
• thiotepa

This is not a complete list of all drug interactions of bupropion. Ask your doctor for more information.

What is the most important information I should know about this medication, depression, and other serious mental illnesses, and suicidal thoughts or actions?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
• Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

What else do I need to know about this bupropion when being treated for depression?

• Never stop this medication without first talking to a healthcare provider. Stopping this medication suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions

Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion.

If you, your family member, or your caregiver notice agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking bupropion and call your healthcare provider right away:

• thoughts about suicide or dying
• an extreme increase in activity and talking (mania)
• attempts to commit suicide
• abnormal thoughts or sensations
• new or worse depression
• seeing or hearing things that are not there (hallucinations)
• new or worse anxiety
• panic attacks
• feeling people are against you (paranoia)
• feeling very agitated or restless
• feeling confused
• acting aggressive, being angry, or violent
• other unusual changes in behavior or mood
• acting on dangerous impulses

When you try to quit smoking, with or without bupropion, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.

Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illnesses. You should also tell your doctor about any symptoms you had during other times you tried to quit smoking, with or without bupropion.

What Other Important Information Should I Know About This Medication?

• Seizure: There is a chance of having a seizure (convulsion, fit) with bupropion , especially in people with certain medical problems or who take certain medicines.
• High blood pressure (hypertension): Some people get high blood pressure, that can be severe, while taking bupropion. The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking.
• Severe allergic reactions: Some people have severe allergic reactions to bupropion. Stop taking bupropion and call your doctor right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
• Unusual thoughts or behaviors: Some patients have unusual thoughts or behaviors while taking bupropion, including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your doctor.

Do not take bupropion if you:

• have or had a seizure disorder or epilepsy.
• are taking any other form of bupropion already (immediate-release, sustained-release, extended-release tablets)
• drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
• have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), or Marplan (isocarboxazid).
• have or had an eating disorder such as anorexia nervosa or bulimia.
• are allergic to the active ingredient in bupropion or to any of the inactive ingredients.

Do not drink a lot of alcohol while taking bupropion. If you usually drink a lot of alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your risk of having seizures.

Do not drive a car or use heavy machinery until you know how bupropion affects you. Bupropion can impair your ability to perform these tasks.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of bupropion there are no specific foods that you must exclude from your diet when receiving bupropion.

Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems.

Tell your doctor about your other medical conditions including if you:

• are pregnant or plan to become pregnant. It is not known if bupropion can harm your unborn baby.
• are breastfeeding. Bupropion passes through your milk. It is not known if bupropion can harm your baby.
• have liver problems, especially cirrhosis of the liver.
• have kidney problems.
• have an eating disorder, such as anorexia nervosa or bulimia.
• have had a head injury.
• have had a seizure (convulsion, fit).
• have a tumor in your nervous system (brain or spine).
• have had a heart attack, heart problems, or high blood pressure.
• are a diabetic taking insulin or other medicines to control your blood sugar.
• drink a lot of alcohol.
• abuse prescription medicines or street drugs.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are using bupropion.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Bupropion passes through your milk. It is not known if bupropion can harm your baby.

• Take bupropion exactly as prescribed by your doctor.
• Take bupropion at the same time each day.
• This immdiate release tablet is usually taken 3 times daily.
• The sustained-release tablet (SR) is usually taken twice daily.
• The extended-release tablet (XL) is usually taken once daily, in the morning.
• You may take bupropion with or without food.
• If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time. This is very important. Too much bupropion can increase your chance of having a seizure.
• Do not take any other medicines while using bupropion unless your doctor has told you it is okay.
• For treating depression, it may take several weeks for you to feel that bupropion is working. Once you feel better, it is important to keep taking bupropion exactly as directed by your doctor. Call your doctor if you do not feel bupropion is working for you.
• Do not change your dose or stop taking bupropion without talking with your doctor first.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how you respond to this medication
• your renal function
• your hepatic function
• the type of bupropion formulation you are taking

The recommended starting dose of bupropion hydrochloride tablets is 200 mg per day, given as 100 mg twice daily. A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day.

The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily.

The usual adult target dose for bupropion hydrochloride extended-release tablets (XL) is 300 mg/day, given once daily in the morning.

If you take too much bupropion call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If bupropion is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

 Buproprion is available in three different types of tablets.

1. Buproprion tablet which is available in both 75mg and 150mg strengths.  This tablet may be taken every eight hours or up to three times a day.
2. Buproprion SR (Sustained Release) is available as a 100mg, 150mg, and 200mg tablet. The Sustained Release coating allows for this medication to be taken every twelve hours or twice a day.
3. Buproprion XL (Extended Release) is available as a 150mg, 300mg, and 450mg tablet. The Extended Release coating on allows for this medication to taken once every twenty four hours or once a day. The 450mg is available only as a brand name medication called Forfivo XL.

• Store bupropion at room temperature.
• Store out of direct sunlight.
• Keep bupropion in its tightly closed bottle.

Warning

Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders:

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

This medication, the sustained release, and the extended release formulations are not approved for smoking cessation treatment, but bupropion under the name bupropion 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.