Serious neuropsychiatric events (eg, depression, suicidal ideation, suicide attempt and completed suicide) have been reported in patients taking varenicline. All patients being treated with varenicline should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms may occur during treatment or after discontinuation of therapy and in patients with or without preexisting psychiatric illness. Drug discontinuation, ongoing monitoring, and supportive care is advised if symptoms develop. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking varenicline in the postmarketing experience. The risks of varenicline should be weighed against the benefits of its use .
Smoking Cessation Agent
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.
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:
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.
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.
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.
|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.|
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.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of 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:
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 1 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.
If you are motivated to quit smoking and did not succeed before treatment with this medicine or if you returned to smoking after taking varenicline, talk with your doctor about whether another course of varenicline treatment may be right for you.
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.
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.
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.
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, 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, tell your doctor right away.
This medicine may cause serious types of allergic reactions, including angioedema. 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 breathing or swallowing, or chest tightness while you are using this medicine.
Serious skin reactions can occur with this medicine. 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.
While you are taking this medicine be careful to limit the amount of alcohol that you drink.
Sleepwalking may occur while you are using this medicine. This can sometimes lead to a behavior that is harmful to you or other people, or to property. Check with your doctor right away if you start sleepwalking.
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:
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:
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.