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Varenicline Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Smoking Cessation

Days 1 to 3: 0.5 mg orally once a day
Days 4 to 7: 0.5 mg orally twice a day
Days 8 to end of treatment: 1 mg orally twice a day

Renal Dose Adjustments

CrCl greater than or equal to 30 mL/min: no adjustment recommended
CrCl less than or equal to 30 mL/min: Recommended initial dose of 0.5 mg orally once a day. May be titrated up to a maximum dose of 0.5 mg twice a day.

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Patients who develop intolerable side effects may benefit from a temporary or permanent decrease in dosage.

It is recommended to treat patients for a minimum duration of 12 weeks. An additional 12 week course of treatment may be beneficial to patients who successfully stopped smoking at the end of the first 12 week session.

Patients who do not successfully stop smoking during initial 12 week session, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed.

Precautions

In an effort to improve tolerability and reduce the incidence of nausea, varenicline should be administered after a meal and with a full glass of water.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Hemodialysis: Varenicline is removed by hemodialysis. Maximum dose of 0.5 mg orally once a day is recommended in patients with end stage renal disease (ESRD) on hemodialysis.
Peritoneal dialysis: Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for varenicline. This includes a medication guide. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Prescribers should carefully instruct patients on how to titrate varenicline and about maintenance dosage.

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 is recommended to further increase the likelihood of long-term abstinence.

Patients should be encouraged to continue to attempt to quit if they have early lapses after quit day.

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