Posology : מינונים

2   DOSAGE AND ADMINISTRATION

2.1 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. Provide patients with appropriate educational materials and counseling to support the quit attempt.

The patient should set a date to stop smoking. Begin CHAMPIX dosing one week before this date.
Alternatively, the patient can begin CHAMPIX dosing and then quit smoking between days 8 and 35 of treatment.

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

The recommended dose of CHAMPIX 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 1 mg twice daily treatment:


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

For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with CHAMPIX. Patients should begin CHAMPIX dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue CHAMPIX treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready [see Clinical Studies (14.5)].

Patients who are motivated to quit, and who did not succeed in stopping smoking during prior CHAMPIX therapy for reasons other than intolerability due to adverse events or who relapsed after treatment, should be encouraged to make another attempt with CHAMPIX once factors contributing to the failed attempt have been identified and addressed.

Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of CHAMPIX.

2.2 Dosage in 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 (estimated creatinine clearance less than 30 mL per min), the recommended starting dose of CHAMPIX is 0.5 mg once daily. The dose may then be titrated as needed to a maximum dose of 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Elderly 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 Use in Specific Populations (8.5)].