Zyban

Zyban is a prescription medication used to help people stop smoking. It belongs to a class of medications called antidepressants. It is unknown how Zyban helps patients quit smoking.

This medication comes in tablet form and is usually taken 2 times a day, with or without food. Zyban tablets should be swallowed whole and not crushed, chewed, or divided.

Common side effects of Zyban include dry mouth, difficulty falling asleep or staying asleep, and nausea. Zyban can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Zyban is a prescription medication used to help patients quit smoking. 

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

• GlaxoSmithKline LLC

Serious side effects have been reported with Zyban. See the “Zyban Precautions” section.

The most common side effects of Zyban are:

• trouble sleeping
• stuffy nose
• dry mouth
• dizziness
• feeling anxious
• nausea
• constipation
• joint aches

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

This is not a complete list of Zyban side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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)
• medications that increase the activity of the enzyme CYP2B6 such as ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital and phenytoin
• medications for irregular heartbeat such as flecainide (Tambocor) and propafenone (Rythmol)
• medications for mental illness such as haloperidol (Haldol), risperidone (Risperdal), and thioridazine (Mellaril)
• other antidepressants such as venlafaxine (Effexor), desipramine (Norpramin), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), paroxetine (Paxil) and sertraline (Zoloft)
• levodopa
• amantadine

This is not a complete list of all drug interactions of Zyban. Ask your doctor 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 Zyban to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with Zyban.

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 Zyban, 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 Zyban, 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 Zyban.

Although Zyban is not a treatment for depression, it contains bupropion, the same active ingredient as the antidepressant medications Wellbutrin, Wellbutrin SR, and Wellbutrin XL. 

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?

• 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

What Other Important Information Should I Know About This Medication?

• Seizure: There is a chance of having a seizure (convulsion, fit) with Zyban, 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 Zyban. 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.
• Manic episodes. Some people may have periods of mania while taking Zyban, including:
  • Greatly increased energy
  • Severe trouble sleeping
  • Racing thoughts
  • Reckless behavior
  • Unusually grand ideas
  • Excessive happiness or irritability
  • Talking more or faster than usual
• Visual problems.
  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

• Severe allergic reactions: Some people have severe allergic reactions to Zyban. Stop taking Zyban 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 Zyban, 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 Zyban 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).
  • Do not take an MAOI within 2 weeks of stopping Zyban unless directed to do so by your healthcare provider.
  • Do not start Zyban if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
• have or had an eating disorder such as anorexia nervosa or bulimia.
• are allergic to the active ingredient in Zyban or to any of the inactive ingredients.

Do not drink a lot of alcohol while taking Zyban. 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 Zyban affects you. Zyban 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 Zyban there are no specific foods that you must exclude from your diet when receiving Zyban.

Before taking Zyban, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have liver problems, especially cirrhosis of the liver.
• have kidney problems.
• have, or have had, an eating disorder such as anorexia nervosa or bulimia.
• ever had depression, suicidal thoughts or actions, or other mental health problems.
• 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 alcohol.
• abuse prescription medicines or street drugs.
• are pregnant or plan to become pregnant.
• are breastfeeding. Zyban passes into your milk in small amounts.

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 Zyban.

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. 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. Zyban's active ingredient, bupropion, passes through breastmilk. It is not known if Zyban can harm your baby.

Start Zyban before you stop smoking to give Zyban time to build up in your body. It takes about 1 week for Zyban to start working.

Pick a date to stop smoking that is during the second week you are taking Zyban.

Take Zyban exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Zyban without talking with your healthcare provider first.

Zyban is usually taken for 7 to 12 weeks. Your healthcare provider may decide to prescribe ZYBAN for longer than 12 weeks to help you stop smoking. Follow your healthcare provider’s instructions.

Swallow Zyban Tablets whole. Do not chew, cut, or crush Zyban Tablets. If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. Tell your healthcare provider if you cannot swallow tablets.

Zyban tablets may have an odor. This is normal.

• Take your doses of Zyban at least 8 hours apart.
• You may take Zyban with or without food.

It is not dangerous to smoke and take Zyban at the same time. But, you will lower your chance of breaking your smoking habit if you smoke after the date you set to stop smoking.

You may use Zyban and nicotine patches (a type of nicotine replacement therapy) at the same time, following the precautions below.

• You should only use Zyban and nicotine patches together under the care of your healthcare provider. Using Zyban and nicotine patches together may raise your blood pressure, and sometimes this can be severe.
• Tell your healthcare provider if you plan to use nicotine patches. Your healthcare provider should check your blood pressure regularly if you use nicotine patches with Zyban to help you quit smoking.

Zyban should be used with a patient support program. It is important to participate in the behavioral program, counseling, or other support program your healthcare professional recommends.

If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time. This is very important. Too much Zyban can increase your chance of having a seizure.

If you take too much Zyban, or overdose, call your local emergency room or poison control center right away.

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

The recommended starting dose of Zyban is 150 mg per day for first 3 days.

Your doctor will increase your dose gradually to reduce seizure risk. 

Your doctor will start your medication one week before quit day.

After 3 days, your doctor will increase the dose to 300 mg per day, given as 150 mg twice daily at an interval of at least 8 hours.

Your doctor will more than likely reduce the dose or reduce the number of times you take Zyban will if your liver and/or kidney does not work well. 

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

If Zyban 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 Zyban at room temperature between 59°F and 86°F (15°C to 30°C).
• Keep Zyban dry and out of the light.
• Keep Zyban and all other medications out of children's reach. 

WARNING: NEUROPSYCHIATRIC REACTIONS; AND SUICIDAL THOUGHTS AND BEHAVIORS

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION

Serious neuropsychiatric reactions have occurred in patients taking ZYBAN® for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of these symptoms have occurred in patients taking ZYBAN who continued to smoke.

The risks of ZYBAN should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared with treatment with placebo. The health benefits of quitting smoking are immediate and substantial.

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Although ZYBAN is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN® , WELLBUTRIN®  SR, and WELLBUTRIN XL® . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.