Applies to the following strength(s): 0.5 mg ; 1 mg ; 0.5 mg-1 mg
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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
-The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date.
-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.
-In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
Use: Smoking cessation
Renal Dose Adjustments
-Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended
-Severe renal impairment (CrCl less than 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 2 times a day
-End-stage renal disease undergoing hemodialysis: A maximum dose of 0.5 mg once daily may be administered if tolerated
Liver Dose Adjustments
No adjustment recommended
-Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue therapy for an additional 12 weeks for a total of 24 weeks of treatment.
-A flexible approach to quitting smoking may be adopted. Patients can begin dosing and then quit smoking between days 8 and 35 of treatment.
-Patients who are motivated to quit and who do not succeed in stopping smoking during prior 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.
-Dose tapering is not required at the end of treatment; however, the dose may be tapered off at the end of treatment for patients with a high risk of relapse.
-A temporary or permanent dose reduction should be considered in patients who cannot tolerate the adverse effects of this drug.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for varenicline. It includes a medication guide. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
US BOXED WARNINGS:
SERIOUS NEUROPSYCHIATRIC EVENTS: Serious neuropsychiatric events (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients taking this drug. Some cases may be complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking this drug who continued to smoke. These events have occurred in patients with and without preexisting psychiatric disease.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
This drug is removed by hemodialysis.
-The tablets should be swallowed whole with water.
-This drug can be taken with or without food.
More about varenicline
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- During Pregnancy or Breastfeeding
- Dosage Information
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- Drug class: smoking cessation agents
Other brands: Chantix