Varenicline

Pronunciation

Generic Name: varenicline (var-EN-i-kleen)
Brand Name: Chantix

Serious mental or mood problems (including depression, suicidal thoughts, suicidal attempts) and completed suicides have been reported in patients taking varenicline. Nicotine withdrawal may also have contributed to some of these events. However, these events have also occurred in patients who continued to smoke. These events have occurred both in patients with and without a history of mental or mood problems. Safety and effectiveness of varenicline in patients with a history of certain mental or mood problems (eg, schizophrenia, bipolar disorder, severe depression) have not been confirmed.

Watch patients who take varenicline closely. Stop taking varenicline and contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood, hostility or agitation, or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

Discuss the benefits and the risks of varenicline with your doctor. Discuss any other questions or concerns with your doctor.


Varenicline is used for:

Helping people to quit smoking cigarettes.

Varenicline is a smoking cessation agent. It works in the brain by blocking the pleasurable effects of smoking. This helps to decrease your desire to smoke.

Do NOT use varenicline if:

  • you are allergic to any ingredient in varenicline or you have developed a skin reaction (eg, red, swollen, blistered, or peeling skin) from taking it

Contact your doctor or health care provider right away if this applies to you.

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Before using varenicline:

Some medical conditions may interact with varenicline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems or dialysis, heart or blood vessel problems, seizures, mental or mood problems (eg, bipolar disorder, depression, schizophrenia), or suicidal thoughts or actions
  • if you have tried to quit smoking before and experienced any unusual symptoms or side effects
  • if you drink alcohol
  • if you are using other medicines to quit smoking

Some MEDICINES MAY INTERACT with varenicline. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Nicotine replacement therapy because the risk of nausea, headache, vomiting, dizziness, stomach upset, and tiredness may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if varenicline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use varenicline:

Use varenicline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Varenicline comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get varenicline refilled.
  • There are 2 ways that you can use varenicline to help you quit smoking. Talk with your doctor about how to start treatment with varenicline.
  • Take varenicline by mouth after a meal with a full glass (8 oz [240 mL]) of water.
  • Take varenicline on a regular schedule to get the most benefit from it. Taking it at the same time each day will help you remember to take it.
  • Even if you smoke after your quit date, continue to try to quit.
  • If you miss a dose of varenicline, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use varenicline.

Important safety information:

  • Varenicline may cause drowsiness or trouble focusing. These effects may be worse if you take it with alcohol or certain medicines. Use varenicline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Traffic accidents and other accidents have happened in people taking varenicline. Discuss any questions or concerns with your doctor.
  • Check with your doctor before you drink alcohol while you are using varenicline. You may need to lower how much alcohol you drink.
  • Varenicline may be used as a part of a treatment program that includes a variety of treatment measures (eg, educational materials, counseling).
  • Tell your doctor about any other medicines that you take. If you are taking certain other medicines (eg, insulin, theophylline, warfarin), quitting smoking may affect their actions or side effects. Your dose of these medicines may need to be changed. Discuss any questions or concerns with your doctor.
  • Some patients have experienced changes in behavior or mood while taking varenicline. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; aggressive, agitated, or abnormal behavior; personality change; thoughts of hurting other people; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • People who try to quit smoking may experience symptoms that could be caused by nicotine withdrawal. These may include the urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, trouble concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some patients may experience worsening of mental health problems they already have, such as depression. Be sure to tell your doctor if you have a history of any of these problems. Discuss any questions or concerns with your doctor.
  • Stroke and heart attack have been reported rarely in patients using varenicline. However, smoking may also increase the risk for these events. Most of the reported cases occurred in patients who had a history of heart or certain blood vessel problems. Contact your doctor right away if you develop symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech, vision problems) or a heart attack (eg, chest, jaw, or left arm pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes). Contact your doctor right away if you develop any symptoms of new or worsening heart or blood vessel problems.
  • A very bad skin reaction (Stevens-Johnson syndrome) has happened with varenicline. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Use varenicline with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using varenicline while you are pregnant. It is not known if varenicline is found in breast milk. Do not breast-feed while taking varenicline.

Possible side effects of varenicline:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; dry mouth; gas; headache; nausea; stomach pain or upset; taste changes; tiredness or weakness; trouble sleeping; vivid, strange, or unusual dreams; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); behavior changes; fainting; fast, slow, or irregular heartbeat; hallucinations; memory loss; new or worsening mental or mood problems (eg, aggression, agitation, anger, anxiety, depression, nervousness, thoughts of hurting other people); persistent trouble sleeping; seizures; severe or persistent headache; severe or persistent nausea; shortness of breath; suicidal thoughts or actions.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of varenicline:

Store varenicline at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep varenicline out of the reach of children and away from pets.

General information:

  • If you have any questions about varenicline, please talk with your doctor, pharmacist, or other health care provider.
  • Varenicline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take varenicline or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about varenicline. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to varenicline. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using varenicline.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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