CHANTIX- varenicline tartrate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

U.S. Pharmaceuticals

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 twice daily. While no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (e

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 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 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
U.S. Pharmaceuticals
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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 problems that
you already have, such as depression.
Before takin

Summary of Product characteristics

CHANTIX- VARENICLINE TARTRATE
U.S. PHARMACEUTICALS
----------
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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions
Neuropsychiatric Symptoms and Suicidality (5.1)
02/2013
Cardiovascular Events (5.4)
12/2012
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
•
•
•
•
•
•
•
•
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
•
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)
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