ZYBAN is an aminoketone agent indicated as an aid to smoking cessation
treatment. (1)ZYBAN is a prescription medicine to help people 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.
Quitting smoking can lower your chances of having lung disease, heart disease, or
1175 getting certain types of cancer that are related to smoking.
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
• Take ZYBAN exactly as prescribed by your healthcare provider. Do not change
your dose or stop taking ZYBAN without talking with your healthcare provider
• 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.
• 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.
Do not take any other medicines while taking ZYBAN unless your
healthcare provider has told you it is okay.
ZYBAN can cause serious side effects. See the sections at the beginning of this
Medication Guide for information about serious side effects of ZYBAN.
The most common side effects of ZYBAN include:
• trouble sleeping
• stuffy nose
• dry mouth
• feeling anxious
• joint aches
If you have trouble sleeping, do not take ZYBAN too close to bedtime.
Tell your healthcare provider right away about any side effects that bother you.
These are not all the possible side effects of ZYBAN. For more information, ask your
healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
You may also report side effects to GlaxoSmithKline at 1-888-825-5249.
Store ZYBAN at room temperature between 59°F and 86°F (15°C to 30°C).
• Keep ZYBAN dry and out of the light.
CYP2B6 inducers: Dose increase may be necessary if coadministered
with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz,
carbamazepine, phenobarbital and phenytoin) based on clinical response,
but should not exceed the maximum recommended dose. (7.1)
• Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can
increase concentrations of: antidepressants (e.g., venlafaxine,
nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline),
antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers
(e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone,
flecainide). Consider dose reduction when using with bupropion. (7.2)
• Drugs that lower seizure threshold: Dose ZYBAN with caution. (5.3, 7.3)
• Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur
when used concomitantly with ZYBAN. (7.4)
• MAOIs: Increased risk of hypertensive reactions can occur when used
concomitantly with ZYBAN. (7.6)
• Drug-laboratory test interactions: ZYBAN can cause false-positive urine
test results for amphetamines. (7.8)
Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in
approximately one-third of all cases. Other serious reactions reported with overdoses of
bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG
changes such as conduction disturbances (including QRS prolongation) or arrhythmias. Fever,
muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been
reported mainly when bupropion was part of multiple drug overdoses.
Although most patients recovered without sequelae, deaths associated with overdoses of
bupropion alone have been reported in patients ingesting large doses of the drug. Multiple
uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported
in these patients.
Consult a Certified Poison Control Center for up–to-date guidance and advice. Telephone
numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR).
Call 1-800-222-1222 or refer to www.poison.org.
There are no known antidotes for bupropion. In case of an overdose, provide supportive care,
including close medical supervision and monitoring. Consider the possibility of multiple drug
overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and
vital signs. Induction of emesis is not recommended.