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 should I discuss with my healthcare 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.
Take this medicine with a full glass of water.
Take the medicine after eating.
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.
Store varenicline at room temperature away from moisture and heat.
What happens if I miss a dose of varenicline?
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.
Where can I get more information about varenicline?
Your pharmacist has information about varenicline written for health professionals that you may read.
What are the possible side effects of varenicline?
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.
Call your doctor at once if you have any of these other serious side effects:
-
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.
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.
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 is going to affect you, be careful if you drive or do anything that requires you
to be cautious and alert.
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.
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 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.
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.
What happens if I have an overdose of varenicline?