Patients should be instructed to set a date to quit smoking and to initiate CHANTIX treatment one week before the quit date.

Patients should be advised that CHANTIX should be taken after eating, and with a full glass of water.

Patients should be instructed how to titrate CHANTIX, beginning at a dose of 0.5 mg/day. Prescribers should explain that one 0.5 mg tablet should be taken daily for the first three days, and that for the next four days, one 0.5 mg tablet should be taken in the morning and one 0.5 mg tablet should be taken in the evening.

Patients should be advised that, after the first seven days, the dose should be increased to one 1 mg tablet in the morning and one 1 mg tablet in the evening.

Patients should be encouraged to continue to attempt to quit if they have early lapses after quit day.

Patients should also be provided with educational materials and necessary counseling to support an attempt at quitting smoking.

Patients should be informed that nausea and insomnia are side effects of CHANTIX and are usually transient; however, patients should be advised that if they are persistently troubled by these symptoms, they should notify the prescribing physician so that a dose reduction can be considered.

Patients should be informed that they may experience vivid, unusual or strange dreams during treatment with CHANTIX.

Patients should be informed that quitting smoking, with or without CHANTIX, may be associated with nicotine withdrawal symptoms (depression, agitation) or exacerbation of preexisting
psychiatric illness. Some patients have experienced depressed mood, agitation, changes in behavior, suicidal ideation and suicide when attempting to quit smoking while taking CHANTIX. They should be urged to report any such symptoms to their health care providers, and to reveal any history of psychiatric illness prior to initiating treatment.

Patients should be informed that some medications may require dose adjustment after quitting smoking.

Patients intending to become pregnant or planning to breastfeed
an infant should be advised of the risks of smoking and risks and benefits of smoking cessation with CHANTIX.

Patients should be advised to use caution driving or operating machinery until they know how quitting smoking with varenicline may affect them.