Medication Guide App

Generic Name: varenicline (ver EN e kleen)
Brand Name: Chantix

What is varenicline?

Varenicline is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

Varenicline may also be used for purposes not listed in this medication guide.

What is the most important information I should know about varenicline?

Varenicline may cause changes in your thoughts or behavior. Stop using this medicine and call your doctor at once if you have: any mood or behavior changes, confusion, anxiety, panic attacks, hallucinations, extreme fear, or if you feel impulsive, agitated, aggressive, restless, hostile, depressed, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

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What should I discuss with my health care provider before taking varenicline?

To make sure you can safely take varenicline, tell your doctor if you have any of these other conditions:

  • a history of depression or mental illness;

  • kidney disease (or if you are on dialysis);

  • heart disease, circulation problems; or

  • if you drink alcohol.

FDA pregnancy category C. It is not known whether varenicline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether varenicline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Varenicline is not approved for use by anyone younger than 18 years old.

How should I take varenicline?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may choose from 2 ways to use varenicline. Ask your doctor which of the following methods is best for you:

  • Set a date to quit smoking and start taking varenicline one week before that date. This will allow the drug to build up in your body. Make sure to quit smoking on your planned quit date.

  • You may also start taking varenicline before you set a planned quit date. Once you start taking the medicine, choose a quit date that is between 8 and 35 days after you start treatment.

To improve your chances for successful smoking cessation, be sure to quit smoking on your planned quit date.

Take varenicline after eating. Take the medicine with a full glass of water.

When you first start taking varenicline, you will take a low dose and then gradually increase your dose over the first several days of treatment. Follow your doctor's dosing instructions very carefully.

In most cases, varenicline treatment lasts for 12 weeks. Your doctor may recommend a second 12-week course of varenicline to improve the chance that you will quit smoking long-term.

Use varenicline regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You should remain under the care of a doctor while taking varenicline.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking varenicline?

Do not drink large amounts alcohol while taking varenicline. This medicine can increase the effects of alcohol.

Do not use other medicines to quit smoking while you are taking varenicline, unless your doctor tells you to. Using varenicline while wearing a nicotine patch can cause unpleasant side effects such as headache, dizziness, upset stomach, nausea, and vomiting.

This medicine may impair your thinking or reactions. You may also have mood or behavior changes when you quit smoking. Until you know how varenicline and the smoking cessation process are going to affect you, be careful if you drive or do anything that requires you to be cautious and alert.

Varenicline side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Varenicline may cause changes in your thoughts or behavior. Stop using varenicline and call your doctor at once if you have any mood or behavior changes, confusion, anxiety, panic attacks, hallucinations, extreme fear, or if you feel impulsive, agitated, aggressive, restless, hostile, depressed, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Your family or other caregivers should also be alert to changes in your mood or behavior.

Call your doctor at once if you have:

  • shortness of breath;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, leg pain when you walk;

  • chest pain or pressure, pain spreading to your jaw or shoulder, vomiting, sweating;

  • seizure (convulsions);

  • the first sign of any blistering type of skin rash, no matter how mild; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea (may persist for several months), vomiting;

  • constipation, gas;

  • sleep problems (insomnia); or

  • unusual dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect varenicline?

After you stop smoking, the doses of any medications you are using may need to be adjusted. Tell your doctor about all other medicines you use, especially:

  • insulin;

  • a blood thinner such as warfarin (Coumadin, Jantoven); or

  • asthma medicine (theophylline and others).

This list is not complete. Other drugs may interact with varenicline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about varenicline.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.01. Revision Date: 2014-11-05, 3:03:53 PM.

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