CHANTIX- varenicline tartrate kit

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Proficient Rx LP

INN (Isem Internazzjonali):

VARENICLINE TARTRATE

Kompożizzjoni:

VARENICLINE 0.5 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 (

Sommarju tal-prodott:

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: Starting 4-week card: 0.5 mg × 11 tablets and 1 mg × 42 tablets NDC 63187-618-53 Starting Month Box: 0.5 mg × 11 tablets and 1 mg × 42 tablets NDC 63187-618-53 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) (see USP Controlled Room Temperature).

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

CHANTIX- VARENICLINE TARTRATE
Proficient Rx LP
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MEDICATION GUIDE
CHANTIX® (CHANT-iks)
(varenicline) Tablets
What is the most important information I should know about CHANTIX?
Some people have had serious side effects while using CHANTIX to help
them quit smoking, including:
New or worse mental health problems, such as changes in behavior,
hostility, agitation, depressed mood,
and 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.
Before taking CHANTIX, tell your doctor if you have ever had
depression or other mental health
problems. You should also tell your doctor about any symptoms you had
during other times you tried to
quit smoking, with or without CHANTIX.
Stop taking CHANTIX and call your doctor right away if you, your
family, or caregiver notice agitation,
hostility, depression or changes in your behavior or thinking that are
not typical for you, or you develop
any of the following symptoms:
•
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 menta

Karatteristiċi tal-prodott

CHANTIX- VARENICLINE TARTRATE
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
INITIAL U.S. APPROVAL: 2006
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
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RECENT MAJOR CHANGES
Dosage and Administration
Usual Dosage for Adults (2.1)
10/2014
Warnings and Precautions
Neuropsychiatric Symptoms and Suicidality (5.1)
09/2014
Seizures (5.2)
09/2014
Interaction with Alcohol (5.3)
09/2014
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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•
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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
•
®
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 d