CHANTIX- varenicline tartrate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VARENICLINE TARTRATE (UNII: 82269ASB48) (VARENICLINE - UNII:W6HS99O8ZO)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CHANTIX is indicated for use as an aid to smoking cessation treatment. CHANTIX is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX. Risk Summary Available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see Data]. Smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see Clinical Considerations) . In animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (MRHD). Additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the MRHD [see Data] . The estimated background risk of oral clefts is increased by

Product summary:

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 Continuing 4-week card: 1 mg × 56 tablets NDC 71205-381-56 Bottles Store at 25ºC (77ºF); excursions permitted to 15–30ºC (59–86ºF) (see USP Controlled Room Temperature).

Authorization status:

New Drug Application

Patient Information leaflet

Proficient Rx LP
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised Feb 2019
MEDICATION GUIDE
CHANTIX® (CHANT-iks)
(varenicline)
Tablets
What is the most important information I should know about CHANTIX?
When you try to quit smoking, with or without CHANTIX, you may have
symptoms that may be due to
nicotine withdrawal, including:
•
urge to smoke
•
depressed mood
•
trouble sleeping
•
irritability
•
frustration
•
anger
•
feeling anxious
•
difficulty concentrating
•
restlessness
•
decreased heart rate
•
increased appetite
•
weight gain
Some people have even experienced suicidal thoughts when trying to
quit smoking without medication.
Sometimes quitting smoking can lead to worsening of mental health
problems that you already have,
such as depression.
Some people have had serious side effects while taking CHANTIX to help
them quit smoking, including:
New or worse mental health problems, such as changes in behavior or
thinking, aggression, hostility,
agitation, depressed mood, or suicidal thoughts or actions. Some
people had these symptoms when they
began taking CHANTIX, and others developed them after several weeks of
treatment, or after stopping
CHANTIX. These symptoms happened more often in people who had a
history of mental health
problems before taking CHANTIX, than in people without a history of
mental health problems.
Stop taking CHANTIX and call your healthcare provider right away if
you, your family, or caregiver
notice any of these symptoms. Work with your healthcare provider to
decide whether you should
continue to take CHANTIX. In many people, these symptoms went away
after stopping CHANTIX, but
in some people symptoms continued after stopping CHANTIX. It is
important for you to follow-up with
your healthcare provider until your symptoms go away.
Before taking CHANTIX, tell your healthcare provider if you have ever
had depression or other mental
health problems. You should also tell your healthcare provider about
any symptoms you ha

Summary of Product characteristics

CHANTIX- VARENICLINE TARTRATE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CHANTIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CHANTIX.
CHANTIX (VARENICLINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Events (5.5)
6/2018
INDICATIONS AND USAGE
CHANTIX is a nicotinic receptor partial agonist indicated for use as
an aid to smoking cessation treatment. (1 and 2.1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 mg and 1 mg (3)
CONTRAINDICATIONS
History of serious hypersensitivity or skin reactions to CHANTIX. (4)
WARNINGS AND PRECAUTIONS
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®
Begin CHANTIX dosing one week before the date set by the patient to
stop smoking. Alternatively, the patient can
begin CHANTIX dosing and then quit smoking between days 8 and 35 of
treatment. (2.1)
Starting Week: 0.5 mg once daily on days 1–3 and 0.5 mg twice daily
on days 4–7. (2.1)
Continuing Weeks: 1 mg twice daily for a total of 12 weeks. (2.1)
An additional 12 weeks of treatment is recommended for successful
quitters to increase likelihood of long-term
abstinence. (2.1)
Consider a gradual approach to quitting smoking with CHANTIX for
patients who are sure that they are not able or
willing to quit abruptly. Patients should begin CHANTIX dosing and
reduce smoking by 50% from baseline within the
first four weeks, by an additional 50% in the next four weeks, and
continue reducing with the goal of reaching
complete abstinence by 12 weeks. Continue treatment for an additional
12 weeks, for a total of 24 weeks. (2.1)
Severe Renal Impairment (estimated creatinine clearance less than 30
mL/min): Begin with 0.5 mg once daily and
titrate to 0.5 mg twice daily. For patients with end-stage renal
disease undergoing hemodialysis, a maximum of 0.5 mg
daily may be given if tolerated. (2.2)
Consider dose reduction for patients