Chantix Indications

CHANTIX is indicated as an aid to smoking cessation treatment.

DOSAGE AND ADMINISTRATION

Usual Dosage for Adults

Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Patients should be provided with appropriate educational materials and counseling to support the quit attempt.

The patient should set a date to stop smoking. CHANTIX dosing should start one week before this date.

CHANTIX should be taken after eating and with a full glass of water.

The recommended dose of CHANTIX is 1 mg twice daily following a 1-week titration as follows:

Days 1 – 3: 0.5 mg once daily
Days 4 – 7: 0.5 mg twice daily
Day 8 – End of treatment: 1 mg twice daily

Patients who cannot tolerate adverse effects of CHANTIX may have the dose lowered temporarily or permanently.

Patients should be treated with CHANTIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHANTIX is recommended to further increase the likelihood of long-term abstinence.

Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed.

Special Populations

Patients with impaired renal function

No dosage adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment, the recommended starting dose of CHANTIX is 0.5 mg once daily. Patients may then titrate as needed to a maximum dose of 0.5 mg twice a day. For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated well (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Pharmacokinetics in Special Populations, Renal impairment).

Dosing in elderly patients and patients with impaired hepatic function

No dosage adjustment is necessary for patients with hepatic impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See PRECAUTIONS, Geriatric Use).

Use in children

Safety and effectiveness of CHANTIX in pediatric patients have not been established; therefore, CHANTIX is not recommended for use in patients under 18 years of age.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be with a healthcare provider, considering the unique characteristics of the patient.

The FDA's public health advisory emphasizes the following safety information on Chantix:

Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.
Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix.
Patients taking Chantix should immediately report changes in mood and behavior to their doctor.
Patients taking Chantix may experience vivid, unusual, or strange dreams.
Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.