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Varenicline tartrate Oral tablet

It is used to help people quit smoking

Generic Name: varenicline

Brand Names: Chantix Starter Pack, Chantix

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[UPDATED 07/22/2011] FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking—those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD). The updated label now also includes alternative directions for patients to select a quit smoking date. For more information visit the FDA website at: [Web] and [Web].

[Posted 06/16/2011] ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline (Chantix) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

BACKGROUND: FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with varenicline or placebo. While cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with varenicline than in patients treated with placebo. The events included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease. FDA is continuing to evaluate the cardiovascular safety of varenicline and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available.

RECOMMENDATION: See the Data Summary section of the Drug Safety Communication for additional information.

Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of varenicline should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.

Patients are encouraged to read the Medication Guide they receive along with their varenicline prescription. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for varenicline tartrate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of varenicline tartrate and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

VARENICLINE (var EN i kleen) is used to help people quit smoking. It can reduce the symptoms caused by stopping smoking. It is used with a patient support program recommended by your physician.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • bipolar disorder, depression, schizophrenia or other mental illness
  • heart disease
  • kidney disease
  • peripheral vascular disease
  • stroke
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to varenicline, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

You should set a date to stop smoking and tell your doctor. Start this medicine one week before the quit date. You can also start taking this medicine before you choose a quit date, and then pick a quit date that is between 8 and 35 days of treatment with this medicine. Stick to your plan; ask about support groups or other ways to help you remain a 'quitter'.

Take this medicine by mouth after eating. Take with a full glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

  • insulin
  • other stop smoking aids
  • theophylline
  • warfarin

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Ask for ongoing advice and encouragement from your doctor or healthcare professional, friends, and family to help you quit. If you smoke while on this medication, quit again

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.


Last Updated: July 25, 2011
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