Zyban

• Storage instructions...
  Store at room temperature in a tightly closed container. Keep out of direct sunlight.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Zyban.

• Side effects include:
  Dry mouth and sleeplessness

These are generally mild and usually disappear after a few weeks. If you have difficulty sleeping, avoid taking Zyban close to bedtime and ask your doctor about reducing your dosage.

Why should Zyban not be prescribed?

Because Zyban has been known to trigger convulsions, no one with a seizure disorder should take this drug. Also avoid Zyban if you are taking any other drug that contains bupropion, Zyban's active ingredient. The more bupropion you take, the more likely you are to have a seizure.

Zyban's seizure-triggering potential is greater in people with an eating disorder such as bulimia or anorexia, and in those undergoing abrupt withdrawal from alcohol, sedatives, and tranquilizers such as Librium and Valium. If you suffer from one of these problems, never take Zyban. Avoid it, too, if you are taking a drug classified as an MAO inhibitor, such as antidepressants. Allow at least 14 days to pass between taking one of these drugs and starting your Zyban therapy.

If bupropion or any other ingredient in Zyban has ever given you an allergic reaction, the drug is not for you.

Special warnings about Zyban

Because the chance of a seizure from Zyban rises with the amount in your system, never take more than one 150-milligram tablet at a time, and limit your total daily intake to 2 doses (300 milligrams).

A variety of conditions can predispose you to seizures, including:

• Prior head injuries
• Prior seizures
• Central nervous system tumors
• Cirrhosis of the liver
• Too much alcohol
• Abrupt withdrawal from alcohol, tranquilizers, or sedatives
• Addiction to narcotics or cocaine
• Use of over-the-counter stimulants or diet pills
• Use of diabetes medications
• Use of antidepressants, major tranquilizers, steroids, or theophylline

If any of these apply to you, use Zyban with care. If you do have a seizure while taking Zyban, stop taking the drug and never take it again.

Stop taking Zyban and call your doctor immediately if you have difficulty breathing or swallowing; notice swelling in your face, lips, tongue, or throat; develop swollen arms and legs; or break out with itchy eruptions. These are warning signs of a potentially severe allergic reaction.

If you have a liver or kidney condition, make sure the doctor is aware of it. Your dosage may need to be reduced. (If you have severe cirrhosis of the liver, your dosage must be reduced.) Also make certain the doctor knows about any heart condition you may have.

Zyban can interfere with your driving ability. Don't drive or operate dangerous machinery until you are certain of the drug's effect on you.

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Possible food and drug interactions when taking Zyban

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If Zyban is used with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Zyban with the following:

• Alcohol
• Amantadine
• Antidepressants
• Beta-blockers (heart and blood pressure medications)
• Carbamazepine
• Cimetidine
• Cyclophosphamide
• Heart-stabilizing drugs
• Levodopa
• Major tranquilizers
• MAO inhibitors
• Orphenadrine
• Phenobarbital
• Phenytoin
• Steroids such as prednisone and hydrocortisone
• Theophylline
• Warfarin

Quitting smoking, with or without Zyban treatment, could change the way your body metabolizes certain drugs, for example, theophylline and warfarin. Make sure your doctor knows all the prescription and over-the-counter medicines you're taking.

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Special information if you are pregnant or breastfeeding

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Zyban has not been tested in pregnant women. If you are pregnant or plan to become pregnant, do your best to quit smoking with the aid of counseling and support before turning to drug therapy. For the sake of the baby, you should avoid smoking or taking nicotine in any other form while pregnant.

Zyban appears in breast milk and could affect a nursing infant. Ask your doctor whether it will be better to discontinue the medication or to stop breastfeeding.

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Recommended dosage for Zyban

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ADULTS

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The usual starting dose is one 150-milligram tablet in the morning for the first 3 days. After that, take one 150-milligram tablet in the morning and another in the early evening. Keep doses at least 8 hours apart. The maximum recommended dose is 300 milligrams daily.

Continue taking Zyban for 7 to 12 weeks. Your doctor may recommend continuing treatment for up to 6 months.

Kidney and Liver Disease

Your doctor may reduce the frequency of your doses to avoid high blood levels of Zyban. If you have severe cirrhosis of the liver, you should take no more than 150 milligrams every other day.

CHILDREN

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The safety and efficacy of Zyban have not been established in children under 18.

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Overdosage

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Information on Zyban overdose is limited. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Zyban overdose may include:
  Blurred vision, confusion, grogginess, jitteriness, light-headedness, nausea, seizure, sluggishness, visual hallucinations