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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.

    Neuropsychiatric Symptoms and Suicide Risk
  • Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving varenicline for smoking cessation. (See Neuropsychiatric Symptoms and Suicidality under Cautions.)
  • Such effects have occurred in patients with or without psychiatric illnesses. Safety and efficacy of varenicline not established in patients with serious psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder); such patients may experience recurrence or worsening of symptoms during varenicline therapy.
  • Depressed mood may be a symptom of nicotine withdrawal; however, some symptoms occurred in varenicline-treated patients who continued to smoke.
  • Most symptoms occurred during varenicline therapy, but some were reported following discontinuance of drug.
  • Monitor all patients receiving varenicline for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).
  • Patient should discontinue varenicline and immediately contact clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.
  • Symptoms resolved upon drug discontinuance in many cases, but persisted in some. Provide ongoing patient monitoring and supportive care until symptoms resolve.
  • Weigh risks of varenicline therapy against benefits of its use for smoking cessation.

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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