Chantix

DRUG DESCRIPTION

CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial agonist selective for ?4?2 nicotinic acetylcholine receptor subtypes.

Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 •C4H6O6. The chemical structure is:

CHANTIX® (varenicline) Structural Formula Illustration

CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with “Pfizer” on one side and “CHX 0.5” on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with “Pfizer” on one side and “CHX 1.0” on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.

What are the possible side effects of varenicline (Chantix)?

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...

Read All Potential Side Effects and See Pictures of Chantix »

What are the precautions when taking varenicline (Chantix)?

Before taking varenicline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (especially kidney dialysis), mental/mood disorders.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for nausea and...

Read All Potential Precautions of Chantix »


Chantix Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, headache, vomiting, drowsiness, gas, constipation, trouble sleeping, unusual dreams, or changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking varenicline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (especially kidney dialysis), mental/mood disorders.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for nausea and other side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Chantix Patient Information Including Side Effects

Brand Names: Chantix

Generic Name: varenicline (Pronunciation: ver EN e kleen)

  • What is varenicline (Chantix)?
  • What are the possible side effects of varenicline (Chantix)?
  • What is the most important information I should know about varenicline (Chantix)?
  • What should I discuss with my health care provider before taking varenicline (Chantix)?
  • How should I take varenicline (Chantix)?
  • What happens if I miss a dose (Chantix)?
  • What happens if I overdose (Chantix)?
  • What should I avoid while taking varenicline (Chantix)?
  • What other drugs will affect varenicline (Chantix)?
  • Where can I get more information?

What is varenicline (Chantix)?

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 are the possible side effects of varenicline (Chantix)?

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 (Chantix)?

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.

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