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CHANTIX- varenicline tartrate kitCHANTIX- varenicline tartrate tablet, film coated

Patient Information

SeeMedication Guide

17.1 Set Quit Date and Continue to Attempt to Quit if Lapse

Instruct patients to set a date to quit smoking and to initiate CHANTIX treatment one week before the quit date. Encourage patients to continue to attempt to quit if they have early lapses after quit day[seeDosage and Administration (2.1)].

17.2 How To Take

Advise patients that CHANTIX should be taken after eating, and with a full glass of water[seeDosage and Administration (2.1)].

17.3 Starting Week Dosage

Instruct patients on how to titrate CHANTIX, beginning at a dose of 0.5 mg/day. 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[seeDosage and Administration (2.1)].

17.4 Continuing Weeks Dosage

Advise patients 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[seeDosage and Administration (2.1)].

17.5 Dosage Adjustment for CHANTIX or Other Drugs

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

Inform patients that some drugs may require dose adjustment after quitting smoking[seeDosage and Administration (2.1)].

17.6 Counseling and Support

Provide patients with educational materials and necessary counseling to support an attempt at quitting smoking[seeDosage and Administration (2.1)].

17.7 Neuropsychiatric Symptoms

Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking CHANTIX. If patients develop agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for them, or if patients develop suicidal ideation or behavior, they should be urged to discontinue CHANTIX and report these symptoms to their healthcare provider immediately[seeBoxed Warning,Warnings and Precautions (5.1),Adverse Reactions (6.2)].

17.8 History of Psychiatric Illness

Encourage patients to reveal any history of psychiatric illness prior to initiating treatment.

17.9 Nicotine Withdrawal

Inform patients that quitting smoking, with or without CHANTIX, may be associated with nicotine withdrawal symptoms (including depression or agitation) or exacerbation of pre-existing psychiatric illness.

17.10 Angioedema

Inform patients that there have been reports of angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue CHANTIX and immediately seek medical care if they experience these symptoms[seeWarnings and Precautions (5.2), andAdverse Reactions (6.2)].

17.11 Serious Skin Reactions

Inform patients that serious skin reactions, such as Stevens-Johnson Syndrome and erythema multiforme, were reported by some patients taking CHANTIX. Advise patients to stop taking CHANTIX at the first sign of rash with mucosal lesions or skin reaction and contact a healthcare provider immediately[seeWarnings and Precautions (5.3), andAdverse Reactions (6.2)].

17.12 Patients with Cardiovascular Disease

Patients with cardiovascular disease should be instructed to notify their health care providers of symptoms of new or worsening cardiovascular events and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction.[seeWarnings and Precautions (5.4), andAdverse Reactions (6.1)].

17.13 Driving or Operating Machinery

Advise patients to use caution driving or operating machinery until they know how quitting smoking and/or varenicline may affect them[seeWarnings and Precautions (5.5)].

17.14 Vivid, Unusual, or Strange Dreams

Inform patients that they may experience vivid, unusual or strange dreams during treatment with CHANTIX.

17.15 Pregnancy and Lactation

Patients who are pregnant or breastfeeding or planning to become pregnant should be advised of: the risks of smoking to a pregnant mother and her developing baby, the potential risks of CHANTIX use during pregnancy and breastfeeding, and the benefits of smoking cessation with and without CHANTIX[seeUse in Specific Populations (8.1and8.3)].

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