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