Drug Uses

Zyban is indicated as an aid to smoking cessation treatment.

How Taken

Zyban comes as a tablet to take it orally. It is usually taken twice a day and may be taken with or without food. It is important to swallow Zyban Tablets whole. Do not chew, divide, or crush tablets.

Warnings/Precautions

Do not take Zyban if you have taken a monoamine oxidase inhibitor (MAOI) in the last 14 days. Zyban is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take Zyban without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Zyban will be harmful to a nursing baby. Do not take Zyban without first talking to your doctor if you are breast-feeding a baby.

Missed Dose

If you forget to take a dose, do not take an extra tablet to catch up for the dose you forgot. Wait and take your next tablet at the regular time. Do not take more tablets than your doctor prescribed. This is important so you do not increase your chance of having a seizure.

Possible Side Effects

Like all medicines, Zyban may cause side effects. Do not rely on this summary alone for information about side effects. Your doctor can discuss with you a more complete list of side effects that may be relevant to you. Hypertension (high blood pressure), in some cases severe, has been reported when taking Zyban alone and in combination with nicotine replacement therapy (for example a nicotine patch). The most common side effects include dry mouth and difficulty sleeping. These side effects are generally mild and often disappear after a few weeks. If you have difficulty sleeping, avoid taking your medicine too close to bedtime. The most common side effects that stopped taking Zyban during clinical studies were shakiness and skin rash. Stop taking Zyban and contact your doctor or health care professional if you have signs of an allergic reaction such as a rash, hives, or difficulty in breathing. It is not possible to predict whether a mild rash will develop into a more serious reaction. Therefore, if you experience a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of lips or tongue, tell a doctor immediately, since these symptoms may be the first signs of a serious reaction. Discuss any other troublesome side effects with your doctor.

Storage

Store Zyban at room temperature, out of direct sunlight. Keep Zyban in a tightly closed container. Keep Zyban out of the reach of children.

Overdose

Seek emergency medical attention if an overdose is suspected. Symptoms of a Zyban overdose include seizures, hallucinations, loss of consciousness, weakness, a fast heartbeat, and heart attack.

More Information

Avoid alcohol or drink it only in moderation while taking Zyban. Alcohol may increase the risk of having a seizure while taking Zyban. However, if you usually drink a lot of alcohol, talk with your doctor before stopping. Suddenly stopping may increase the risk of having a seizure. Talk to your doctor about alcohol use before starting treatment with Zyban. Use caution when driving, operating machinery, or performing other hazardous activities. Zyban may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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The drug is called Chantix. It comes in tablet form and is not recommended for pregnant smokers, smokers younger than 18, or use with other smoking-cessation products, the FDA's Curt Rosebraugh, MD, MPH, told reporters at a teleconference.
Rosebraugh is the deputy director of the Office for Drug Evaluation II at the FDA's Center for Drug Evaluation and Research.
The active ingredient in Chantix, varenicline tartrate, is a new drug that got a priority FDA review; it took six months for approval instead of the usual 10 months for routine reviews.
"We did a priority review because at the time the application was filed, a preliminary review of the efficacy studies indicated that smokers treated with Chantix may have a superior rate of smoking cessationsmoking cessation compared to another currently approved smoking-cessation product, which was Zyban," Rosebraugh says.
12 Weeks of Treatment
The approved course of Chantix treatment is 12 weeks, but longer treatment may help some patients. In addition to Chantix, counseling is also recommended as part of the treatment program.
"The way that the label is written is that if you take 12 weeks of therapy and successfully stop smoking at the end of that 12 weeks, an additional 12-week course of treatment is recommended to further increase the likelihood of long-term smoking cessation," Rosebraugh says.
Chantix acts at the same sites in the brain as nicotine. It may help people who want to quit smoking in two ways: by providing some nicotine effects to ease withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.
"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction," says Steven Galson, MD, MPH, in the FDA news release. Galson directs the FDA's Center for Drug Evaluation and Research.
"Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit," Galson says.
The effectiveness of Chantix in smoking cessationsmoking cessation was demonstrated in six clinical trials, which included 3,659 chronic cigarette smokers who were treated with Chantix.
Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smokingquit smoking. These smokers had previously averaged 21 cigarettes a day for about 25 years.
In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban, states the FDA's news release.
In those two studies, both Chantix and Zyban were superior to placebo. After 12 weeks of treatment, a bigger proportion of Chantix users had quit smoking.
But 50 weeks after treatment stopped, the differences between the percentage of people who had used Chantix or Zyban and were still smoke-free weren't statistically significant, meaning they may have been due to chance, notes Rosebraugh.
In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomniainsomnia, abnormal dreams, and dysgeusia (change in taste perception), according to the FDA.
Chantix is made and distributed by the drug company Pfizer.
American Cancer Society's Comments
The American Cancer Society issued a statement on Chantix. The statement is attributed to Thomas J. Glynn, PhD, the American Cancer Society's director for cancer and science trends and for international tobacco programs.
In the statement, Glynn calls the drug's approval "very welcome news."
While noting that long-term results in real-life settings aren't yet clear, Glynn says "if smokers comply with the Chantix treatment regimen and take advantage of an accompanying behavioral treatment program, we would expect success rates to be high and, equally important, that smokers and those who treat them will have an important new tool to call upon."

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