Pronunciation:

var-EN-i-kleen

Brand Names:

• Chantix
• Chantix Start Month Pak

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Smoking Cessation Agent

Uses of This Medicine:

Varenicline is used as part of a support program to help you stop smoking. Educational materials and necessary counseling should also be provided as part of the support program .

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of varenicline in in children up to 18 years of age. Safety and efficacy have not been established and use is not recommended .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of varenicline in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require care in dosing and monitoring in patients receiving varenicline .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Mental illness—Use with caution. Quitting smoking with or without treatment with varenicline can cause nicotine withdrawal symptoms and may make these conditions worse .

• Kidney problems—Caution should be used. For severe kidney problems, your doctor will start you on a lower dose .

Proper Use of This Medicine:

You should set a date to stop smoking. You should start taking varenicline one week before this date .

You should take this medicine with a full glass of water after eating .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For an aid to stop smoking:
  • For oral dosage form (tablet):
    • Adults—
      • Days 1 to 3: 0.5 milligram (mg) one time a day.
      • Days 4 to 7: 0.5 milligram (mg) two times a day.
      • Days 8 to End of treatment: 1 milligram (mg) twice a day .
    • Children—Use and dose will be determined by your doctor.

If you have successfully stopped smoking at the end of 12 weeks, your doctor may prescribe another 12 weeks of this medicine to increase your long-term abstinence .

If you do not succeed in stopping smoking during the first 12 weeks or if you relapse during treatment, you should make another attempt after you have addressed concerns with your doctor .

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

If your symptoms, especially nausea and insomnia, do not improve or if they persist, check with your doctor .

You should inform your doctor of any medicines that you are taking. After you quit smoking, your doctor may need to adjust doses on some of your medicines .

Make sure your doctor knows if you are pregnant or breastfeeding. This medicine should only be used if your doctor tells you to. Smoking can seriously harm your unborn child. Try to stop smoking without using medicine. This medicine is believed to be safer than smoking. However, the risks to your unborn child from the medicine are not fully known .

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away .

Make sure you know how quitting smoking with this medicine may affect you before you drive, use machines, or do anything else that could be dangerous if you are not alert .

You will probably still want to smoke sometimes. Have a plan for coping with situations where you may be tempted to smoke. This medicine is only part of a complete program to quit smoking .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Difficult or labored breathing

shortness of breath

tightness in chest

wheezing

Incidence not known

Changes in behavior

thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abnormal dreams

bloated, full feeling

change in taste

difficulty having a bowel movement (stool)

dry mouth

excess air or gas in stomach or intestines

general feeling of discomfort or illness

headache

lack or loss of strength

loss of taste

nausea

passing gas

sleeplessness

stomach pain

trouble sleeping

unable to sleep

unusual tiredness or weakness

Less common

Acid or sour stomach

belching

body aches or pain

chills

cough

decreased appetite

ear congestion

fever

heartburn

increased appetite

indigestion

itching skin

loss of appetite

loss of voice

nasal congestion

nightmare

rash

runny nose

sleepiness or unusual drowsiness

sneezing or sore throat

stomach discomfort or upset

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

Incidence not known

Anxiety

discouragement

feeling sad or empty

hyperventilation

irregular heartbeats

irritability

loss of interest or pleasure

nervousness

restlessness

shaking

trouble concentrating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.