CHANTIX varenicline tartrate tablet film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Cardinal Health

INN (Isem Internazzjonali):

varenicline tartrate

Kompożizzjoni:

varenicline 0.5 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

CHANTIX- VARENICLINE TARTRATE TABLET, FILM COATED
CARDINAL HEALTH
----------
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
Dosage and Administration
Alternative Instructions for Setting a Quit Date (2.1) 7/2011
Warnings and Precautions
Cardiovascular Events (5.4)
7/2011
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. 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)
Renal impairment: Reduce the dose in