Serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide have been reported in patients taking varenicline. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking varenicline who continued to smoke.
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, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking varenicline in the post-marketing experience. When symptoms were reported, most were during varenicline treatment, but some were following discontinuation of varenicline therapy.
These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of varenicline and the safety and efficacy of varenicline in such patients has not been established.
Advise patients and caregivers that the patient should stop taking varenicline and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of varenicline was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.
The risks of varenicline should be weighed against the benefits of its use. Varenicline has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial .
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. 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 .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Smoking Cessation Agent
Varenicline is used as part of a support program to help you stop smoking. Educational materials and necessary counseling should also be provided as part of the support program .
varenicline 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 varenicline, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to varenicline 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 in children up to 18 years of age. Safety and efficacy have not been established and use is not recommended .
Appropriate studies performed to date have not demonstrated geriatrics-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 care in dosing and monitoring in 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
The presence of other medical problems may affect the use of varenicline. Make sure you tell your doctor if you have any other medical problems, especially:
You should set a date to stop smoking. You should start taking varenicline one week before this date .
You should take varenicline with a full glass of water after eating .
The dose of varenicline 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 varenicline. 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 have successfully stopped smoking at the end of 12 weeks, your doctor may prescribe another 12 weeks of varenicline to increase your long-term abstinence .
If you do not succeed in stopping smoking during the first 12 weeks or if you relapse during treatment, you should make another attempt after you have addressed concerns with your doctor .
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.
If your symptoms, especially nausea and insomnia, do not improve or if they persist, check with your doctor .
You should inform your doctor of any medicines that you are taking. After you quit smoking, your doctor may need to adjust doses on some of your medicines .
Make sure your doctor knows if you are pregnant or breastfeeding. varenicline should only be used if your doctor tells you to. Smoking can seriously harm your unborn child. Try to stop smoking without using medicine. varenicline is believed to be safer than smoking. However, the risks to your unborn child from the medicine are not fully known .
varenicline 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 .
Make sure you know how quitting smoking with varenicline may affect you before you drive, use machines, or do anything else that could be dangerous if you are not alert .
You will probably still want to smoke sometimes. Have a plan for coping with situations where you may be tempted to smoke. varenicline is only part of a complete program to quit smoking .
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
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
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.
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