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.
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