CHANTIX- varenicline tartrate kit 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:

Physicians Total Care, Inc.

INN (International Name):

VARENICLINE TARTRATE

Composition:

VARENICLINE 0.5 mg

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 Pregnancy Category C. There are no adequate and well-controlled studies of CHANTIX use in pregnant women. In animal studies, CHANTIX caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. CHANTIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. These exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on AUC) at the maximum recommended human dose (MRHD) of 1 mg BID. While no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (exposures

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: Store at 25ºC (77ºF); excursions permitted to 15–30ºC (59–86ºF) (see USP Controlled Room Temperature).

Authorization status:

New Drug Application

Patient Information leaflet

CHANTIX - VARENICLINE TARTRATE
CHANTIX - VARENICLINE TARTRATE TABLET, FILM COATED
Physicians Total Care, Inc.
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MEDICATION GUIDE
CHANTIX (CHANT-iks)
(varenicline) Tablets
Read the Medication Guide that comes with CHANTIX before you start
taking it and each time you get a
refill. There may be new information. This information does not take
the place of talking with your doctor
about your condition or treatment.
What is the most important information I should know about CHANTIX?
Some people have had changes in behavior, hostility, agitation,
depressed mood, and suicidal thoughts or
actions while using CHANTIX to help them quit smoking. Some people had
these symptoms when they
began taking CHANTIX, and others developed them after several weeks of
treatment, or after stopping
CHANTIX.
If you, your family, or caregiver notice agitation, hostility,
depression or changes in behavior or thinking
that are not typical for you, or you develop any of the following
symptoms, stop taking CHANTIX and
call your doctor right away:
•
thoughts about suicide or dying, or attempts to commit suicide
•
new or worse depression, anxiety, or panic attacks
•
feeling very agitated or restless
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
abnormal thoughts or sensations
•
seeing or hearing things that are not there (hallucinations)
•
feeling people are against you (paranoia)
•
feeling confused
•
other unusual changes in behavior or mood
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, and increased appetite
or 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 probl

Summary of Product characteristics

CHANTIX - VARENICLINE TARTRATE
CHANTIX - VARENICLINE TARTRATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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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
INITIAL U.S. APPROVAL: 2006
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Serious neuropsychiatric events have been reported in patients taking
CHANTIX. ( 5.1 and 6.2)
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 while taking CHANTIX or
shortly after discontinuing CHANTIX. ( 5.1 and 6.2)
Weigh the risks of CHANTIX against 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. ( 5.1 and
6.2)
RECENT MAJOR CHANGES
Contraindications
4/2010
Known Hypersensitivity (4)
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
Begin CHANTIX dosing one week before the date set by the patient to
stop smoking. (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)
Renal impairment: Reduce the dose in patients with severe renal
impairment (estimated creatinine clearance <30
mL/min). (2.2)
Consider dose reduction for patients who cannot tolerate adverse
effects