Usual Dosage for Adults

The patient should set a date to stop smoking.
SmokeLESS dosing should start one week before this date.
SmokeLESS should be taken after eating and with a full glass of water.

The recommended dose of SmokeLESS 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

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

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 SmokeLESS 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.

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.

Use in children

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

Things to remember when taking SmokeLESS

- SmokeLESS should be taken after eating and with a full glass (8 ounces) of water.

- If patients miss a dose, they should take it as soon as they remember. If it's close to the time of the next dose, they should wait. Then just take the next regular dose.

- If patients slip up and smoke while taking SmokeLESS, they should not give up and keep trying to quit and keep taking SmokeLESS.
Some people need a few weeks for it to work best. In studies, some people who smoked after their Quit Date were able to quit successfully.

- Even if patients successfully quit smoking in the first few weeks of their SmokeLESS treatment, they should remember that SmokeLESS is recommended for the full 12 weeks. In studies, 44% of people who took varenicline were quit during weeks 9 to 12 of treatment (compared 18% on sugar pill).

- Some patients have reported changes in behavior, agitation, depressed mood, suicidal thoughts or actions when attempting to quit smoking while taking varenicline or after stopping it. If either the patient, his/her family, or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for them, or if they develop suicidal thoughts or actions, they should stop taking SmokeLESS and call the doctor right away. Also they should tell the doctor about any history of depression or other mental health problems before taking SmokeLESS, as these symptoms may worsen while taking SmokeLESS.

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