Champix Dosage/Direction for Use

Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
The recommended dose of varenicline is 1 mg twice daily following a 1-week titration as follows: See Table 19.

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The patient should set a date to stop smoking. Varenicline dosing should start 1 week before this date. Alternatively, a flexible approach to quitting may be adopted: the patient can begin varenicline dosing and then quit smoking between Days 8 and 35 of treatment (see Pharmacology: Pharmacodynamics: Flexibility in Setting a Quit Date under Actions).
Patients should be treated with varenicline for 12 weeks.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with varenicline at 1 mg twice daily is recommended for the maintenance of abstinence (see Pharmacology: Pharmacodynamics: Maintenance of Abstinence Study under Actions).
A gradual approach to quitting smoking with varenicline should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue taking varenicline for an additional 12 weeks for a total of 24 weeks of treatment (see Pharmacology: Pharmacodynamics: Gradual Approach to Quitting Smoking under Actions).
Patients who are motivated to quit and who did not succeed in stopping smoking during prior varenicline therapy, or who relapsed after treatment, should be encouraged to make another attempt with varenicline (see Pharmacology: Pharmacodynamics: Study in Subjects Re-treated with Varenicline under Actions).
Patients who cannot tolerate adverse effects of varenicline may have the dose lowered temporarily or permanently.
Varenicline tablets should be swallowed whole with water. Varenicline can be taken with or without food.
Patients with renal insufficiency: No dosage adjustment is necessary for patients with mild (estimated creatinine clearance >50 ml/min and ≤80 ml/min) to moderate (estimated creatinine clearance ≥30 ml/min and ≤50 ml/min) renal impairment.
For patients with severe renal impairment (estimated creatinine clearance <30 ml/min), the recommended dose of varenicline is 1 mg once daily. Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily. There is insufficient clinical experience with varenicline in patients with end stage renal disease (see Pharmacology: Pharmacokinetics: Patients with renal insufficiency under Actions).
Patients with hepatic impairment: No dosage adjustment is necessary for patients with hepatic impairment (see Pharmacology: Pharmacokinetics: Patients with hepatic impairment under Actions).
Use in elderly patients: No dosage adjustment is necessary for elderly patients. Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient (see Patients with renal insufficiency as previously mentioned and Pharmacology: Pharmacokinetics: Patients with renal insufficiency and Use in elderly patients under Actions.)
Use in pediatric patients: Varenicline is not recommended for use in pediatric patients because its efficacy in this population was not demonstrated (see Pharmacology: Pharmacodynamics: Pediatric population and Pharmacokinetics: Use in pediatric patients under Actions).