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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for varenicline tartrate (Chantix) regarding serious neuropsychiatric symptoms experienced in patients taking varenicline tartrate. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking varenicline tartrate who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during varenicline tartrate treatment, but in others, symptoms developed following withdrawal of varenicline tartrate therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using varenicline tartrate therapy for patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline, http://www.fda.gov/cder/drug/advisory/varenicline.htm, http://www.fda.gov/cder/foi/label/2008/021928s007lbl.pdf and http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm. |
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Varenicline is used to help people stop smoking. Varenicline is in a class of medications called smoking cessation aids. It works by blocking the pleasant effects of nicotine (from smoking) on the brain.
Varenicline comes as a tablet to take by mouth. It is usually taken once or twice a day with a full glass of water after eating. Take varenicline at around the same time(s) every day. If you are taking varenicline twice a day, take one dose in the morning and one dose in the evening. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take varenicline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of varenicline and gradually increase your dose over the first week of treatment.
Set a quit date to stop smoking, and start taking varenicline 1 week before that date. You may continue to smoke during this first week, but make sure to try to stop smoking on the date you have chosen.
It may take several weeks for you to feel the full benefit of varenicline. You may slip and smoke during your treatment. If this happens, you may still be able to stop smoking. Continue to take varenicline and to try not to smoke.
You will probably take varenicline for 12 weeks. If you have completely stopped smoking at the end of 12 weeks, your doctor may tell you to take varenicline for another 12 weeks. This may help keep you from starting to smoke again.
If you have not stopped smoking at the end of 12 weeks, talk to your doctor. Your doctor can try to help you understand why you were not able to stop smoking and make plans to try to quit again.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking varenicline,
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Varenicline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
Varenicline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Revised -
12/01/2007
Last Reviewed -
01/01/2007

The MedMaster Patient Drug Information database provides information copyrighted by the American Society of Health-System Pharmacists, Inc., Bethesda, Maryland Copyright© 2008. All Rights Reserved.
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Page last updated: 17 April 2008 |