WARNING:
All patients being treated with CHANTIX should be observed
for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood,
and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms,
as well as worsening of pre-existing psychiatric illness and completed suicide have been reported
in some patients attempting to quit smoking while taking CHANTIX in the post-marketing experience.
When symptoms were reported, most were during CHANTIX treatment, but some were following
discontinuation of CHANTIX therapy.
These events have occurred in patients with and without
pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia,
bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies
of CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established.
Advise patients and caregivers that the patient
should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility,
depressed mood, or changes in behavior or thinking that are not typical for the patient are observed,
or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases,
resolution of symptoms after discontinuation of CHANTIX was reported, although in some cases the
symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until
symptoms resolve.
The risks of CHANTIX should be weighed against the benefits
of its use. CHANTIX has been demonstrated to increase the likelihood of abstinence from smoking for
as long as one year compared to treatment with placebo. The health benefits of quitting smoking are
immediate and substantial.
(See WARNINGS/Neuropsychiatric Symptoms and Suicidality, PRECAUTIONS/Information for Patients, and
ADVERSE REACTIONS/Post-Marketing Experience )
CHANTIX® 4 2
Varenicline, as the tartrate salt, is a powder which is a white
to off-white to slightly yellow solid with the following chemical name:
7,8,9,10-tetrahydro-6,10-methano-6H -pyrazino[2,3-h][3]benzazepine,
(2R ,3R )-2,3-dihydroxybutanedioate (1:1). It is highly soluble
in water. Varenicline tartrate has a molecular weight of 361.35 Daltons,
and a molecular formula of C13 13 3 ·
C4 6 6
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. Each 0.5 mg CHANTIX tablet contains
0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free
base; each 1mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent
to 1 mg of varenicline free base. The following inactive ingredients are
included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium
phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate,
Opadry® ® ®