Varenicline

Generic name: Varenicline
Dosage form: oral tablet (0.5 mg; 0.5 mg-1 mg; 1 mg)

Usage of 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 purposes not listed in this medication guide.

Varenicline side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Varenicline may cause serious side effects. Stop using varenicline and call your doctor at once if you have:

a seizure (convulsions);

thoughts about suicide or hurting yourself;

strange dreams, sleepwalking, trouble sleeping;

new or worsening mental health problems--mood or behavior changes, depression, agitation, hostility, aggression;

heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; o

stroke symptoms--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance.

Your family or other caregivers should also be alert to changes in your mood or behavior.

Common side effects of varenicline may include:

nausea (may persist for several months), vomiting;

constipation, gas;

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.

Before taking Varenicline

You should not use varenicline if you used it in the past and had:

a serious allergic reaction--trouble breathing, swelling in your face (lips, tongue, throat) or neck; or

a serious skin reaction--blisters in your mouth, peeling skin rash.

Tell your doctor if you have ever had:

depression or mental illness;

a seizure;

kidney disease (or if you are on dialysis);

heart or blood vessel problems; or

if you drink alcohol.

Tell your doctor if you are pregnant. It is not known whether varenicline will harm an unborn baby if you use the medicine during pregnancy. However, smoking while you are pregnant can harm the unborn baby or cause birth defects.

If you breast-feed while using varenicline, your baby may spit up or vomit more than normal, and may have a seizure.

Varenicline is not approved for use by anyone younger than 18 years old.

How to use Varenicline

Usual Adult Dose for Smoking Cessation:

Days 1 to 3: 0.5 mg orally once a dayDays 4 to 7: 0.5 mg orally 2 times a dayDays 8 to end of treatment: 1 mg orally 2 times a dayDuration of therapy: 12 weeksComments:-The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date OR the patient may begin treatment and quit smoking between Days 8 and 35.-Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.-In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.Use: As an aid to smoking cessation treatment

Warnings

When you stop smoking, you may have nicotine withdrawal symptoms with or without using medication such as varenicline. This includes feeling restless, depressed, angry, frustrated, or irritated.

Stop taking varenicline and call your doctor if you have if you feel depressed, agitated, hostile, aggressive, or have thoughts about suicide or hurting yourself.

Do not drink large amounts alcohol. Varenicline can increase the effects of alcohol or change the way you react to it.

What other drugs will affect Varenicline

After you stop smoking, your doctor may need to adjust the doses of certain medicines you take on a regular basis.

Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Disclaimer

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