Varenicline

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 other purposes not listed in this medication guide.

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

Before using varenicline, tell your doctor if you have kidney disease, or a history of mental illness.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

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

Less serious side effects are more likely, and you may have none at all. Varenicline can cause persistent nausea for up to several months. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can interact with varenicline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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

Before using varenicline, tell your doctor if you have kidney disease, or a history of mental illness. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether varenicline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old.

How should I take varenicline?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

To improve your chances for successful smoking cessation, set a date to quit smoking. Start taking varenicline one week before your planned quit date.

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 instructions. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

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.

It is important to take varenicline regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is not causing harmful effects, your kidney function may need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. Be sure to take the medicine after eating.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a varenicline overdose are unknown.

What should I avoid while taking varenicline?

Varenicline can cause drowsiness, which 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. Stop using this medication and call your doctor at once if you have any mood or behavior changes, or if you feel agitated, hostile, depressed, or have thoughts about suicide or hurting yourself.

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

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

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

Less serious side effects may include:

• nausea (may persist for several months);

• stomach pain, indigestion, vomiting, constipation, gas;

• weakness, tired feeling;

• increased appetite;

• unpleasant taste in your mouth;

• headache; or

• 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.

Varenicline Dosing Information

Usual Adult Dose for Smoking Cessation:

Days 1 - 3: 0.5 mg orally once a day
Days 4 - 7: 0.5 mg orally twice a day
Days 8 - end of treatment: 1 mg orally twice a day

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); or

• theophylline (Respbid, Theobid, Theoclear, Theo-Dur, Uniphyl).

This list is not complete and there may be other drugs that can interact with or be affected by varenicline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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.
• 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.