"The US Food and Drug Administration (FDA) has changed the labeling on the smoking cessation drug varenicline (Chantix, Pfizer Inc) to reflect concerns that the drug may lower tolerance to alcohol and is linked to a rare risk for seizures"...
DOSAGE AND ADMINISTRATION
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. Provide patients with appropriate educational materials and counseling to support the quit attempt.
The patient should set a date to stop smoking. Begin CHANTIX dosing one week before this date. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment.
CHANTIX should be taken after eating and with a full glass of water.
The recommended dose of CHANTIX 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 should be treated with CHANTIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks' treatment with CHANTIX 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.
Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of CHANTIX.
Dosage In 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 (estimated creatinine clearance < 30 mL/min), the recommended starting dose of CHANTIX is 0.5 mg once daily. The dose may then be titrated 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 [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
Elderly 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 [see Use In Specific Populations].
Dosage Forms And Strengths
Capsular, biconvex tablets: 0.5 mg (white to off-white, debossed with “Pfizer” on one side and “CHX 0.5” on the other side) and 1 mg (light blue, debossed with “Pfizer” on one side and “CHX 1.0” on the other side).
Storage And Handling
CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with “Pfizer” on one side and “CHX 0.5” on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with “Pfizer” on one side and “CHX 1.0” on the other side. CHANTIX is supplied in the following package configurations:
|Packs||Starting Month PAK (First month of therapy): Pack includes 1 card of 0.5 mg x 11 tablets and 3 cards of 1 mg x 14 tablets||NDC 0069-0471-97|
|Continuing Month PAK (Continuing months of therapy): Pack includes 4 cards of 1 mg x 14 tablets||NDC 0069-0469-97|
|Starting Month Box: 0.5 mg x 11 tablets and 1 mg x 42 tablets||NDC 0069-0471-02|
|Continuing Month Box : 1 mg x 56 tablets||NDC 0069-0469-12|
|Bottles||0.5 mg - bottle of 56||NDC 0069-0468-56|
|1 mg - bottle of 56||NDC 0069-0469-56|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) (see USP Controlled Room Temperature).
Distributed by: Pfizer Labs, Diuisnn of Pfizer Inc, Nr, NY 10G17. Revised September 2014
Last reviewed on RxList: 10/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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