Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Chantix
  2. Chantix Starter Pack
  3. Chantix Starting Month Box
  4. Chantix Start Month Pak

Descriptions


Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.

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

This product is available in the following dosage forms:

  • Tablet

Before Using

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of varenicline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-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 caution and an adjustment in the dose for patients receiving varenicline.

Pregnancy

Information about this varenicline-oral-route
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.

Breastfeeding

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.

Drug Interactions

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:

  • Angina (severe chest pain), history of or
  • Heart attack, history of or
  • Heart or blood vessel problems or
  • Stroke, history of—May increase risk to have more serious side effects.
  • Depression, history of or
  • Mental problems (e.g., psychosis), history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. It is also important to participate in a stop-smoking program while you use this medicine. This will make it easier for you to quit smoking.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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

Your doctor may also tell you to start taking this medicine anytime and then to stop smoking between days 8 and 35 of treatment.

You may be told to take this medicine for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take this medicine for 12 more weeks to help you keep off smoking.

Take this medicine after eating, and with a full glass of water.

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 oral dosage form (tablets):
    • To stop smoking:
      • Adults—
        • Days 1 to 3: 0.5 milligram (mg) once a day.
        • Days 4 to 7: 0.5 mg two times per day.
        • Days 8 to end of treatment: 1 mg two times per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. This will allow for changes in your dose and to help reduce any side effects.

This medicine may increase your risk of having a heart attack in certain patients with heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; pain in your legs when walking; shortness of breath; sweating; or troubled breathing.

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, stop taking this medicine and tell your doctor right away.

This medicine may cause serious types of allergic reactions, including angioedema. Stop taking this medicine and tell your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

This medicine may cause some people to become drowsy or dizzy, or to have problems with concentration. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or thinking clearly.

Tell your doctor if you have nausea or sleep problems (trouble sleeping or unusual dreams) while you are using this medicine. The dose of this medicine may need to be adjusted.

Side Effects

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

  1. Difficult or labored breathing
  2. hyperventilation
  3. shortness of breath
  4. tightness in the chest
  5. wheezing

Incidence not known

  1. Anger
  2. anxiety
  3. behavior changes
  4. depression
  5. discouragement
  6. feeling sad or empty
  7. feelings of panic
  8. hallucinations
  9. irregular heartbeats
  10. irritability
  11. loss of interest or pleasure
  12. mood swings
  13. nervousness
  14. restlessness
  15. 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

  1. Abnormal dreams
  2. bloated or full feeling
  3. change in taste
  4. difficulty having a bowel movement (stool)
  5. dry mouth
  6. excess air or gas in the stomach or intestines
  7. general feeling of discomfort or illness
  8. headache
  9. lack or loss of strength
  10. loss of taste
  11. nausea
  12. passing gas
  13. sleeplessness
  14. stomach pain
  15. trouble sleeping
  16. unable to sleep
  17. unusual tiredness or weakness

Less common

  1. Acid or sour stomach
  2. belching
  3. body aches or pain
  4. chills
  5. cough
  6. decreased appetite
  7. dizziness
  8. ear congestion
  9. fever
  10. heartburn
  11. increased appetite
  12. indigestion
  13. itching skin
  14. loss of appetite
  15. loss of voice
  16. nightmares
  17. rash
  18. runny nose
  19. sleepiness or unusual drowsiness
  20. sneezing or sore throat
  21. stomach discomfort or upset
  22. stuffy nose
  23. trouble concentrating
  24. unusual drowsiness, dullness, or feeling of sluggishness
  25. vomiting

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.