CHANTIX- varenicline tartrate tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

varenicline tartrate (UNII: 82269ASB48) (varenicline - UNII:W6HS99O8ZO)

থেকে পাওয়া:

Rebel Distributors Corp

INN (International Name):

varenicline tartrate

রচনা:

varenicline 0.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 5

পণ্য সারাংশ:

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).

অনুমোদন অবস্থা:

New Drug Application

তথ্য লিফলেট

CHANTIX- VARENICLINE TARTRATE TABLET, FILM COATED
Rebel Distributors Corp
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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 healthcare provider 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 ha

পণ্য বৈশিষ্ট্য

CHANTIX- VARENICLINE TARTRATE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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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
Boxed Warning
7/2009
Contraindications
4/2010
Known Hypersensitivity (4)
Warnings and Precautions
7/2009
Neuropsychiatric Symptoms and Suicidality (5.1), Angioedema and
Hypersensitivity Reactions (5.2), Serious Skin Reactions (5.3),
Accidental Injury (5.4)
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 d