VARENICLINE 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:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline.   Risk Summary   Available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see Data]. Smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see Clinical Considerations). In animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (MRHD). Additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the MRHD [see Data] . The estimated background risk

Product summary:

Product: 50090-6446 NDC: 50090-6446-0 56 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VARENICLINE- VARENICLINE TABLET, FILM COATED
A-S Medication Solutions
----------
MEDICATION GUIDE
Varenicline Tablets
(va-ren-i-cline)
What is the most important information I should know about varenicline
tablets?
When you try to quit smoking, with or without varenicline tablets, 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
· increased appetite
· 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.
Some people have had serious side effects while taking varenicline
tablets to help them quit smoking,
including:
New or worse mental health problems, such as changes in behavior or
thinking, aggression, hostility,
agitation, depressed mood, or suicidal thoughts or actions. Some
people had these symptoms when they
began taking varenicline tablets, and others developed them after
several weeks of treatment, or after
stopping varenicline tablets. These symptoms happened more often in
people who had a history of mental
health problems before taking varenicline tablets, than in people
without a history of mental health
problems.
Stop taking varenicline tablets and call your healthcare provider
right away if you, your family, or
caregiver notice any of these symptoms. Work with your healthcare
provider to decide whether you
should continue to take varenicline tablets. In many people, these
symptoms went away after stopping
varenicline tablets, but in some people, symptoms continued after
stopping varenicline tablets. It is
important for you to follow-up with your healthcare provider until
your symptoms go away.
Before taking varenicline tablets, tell your healthcare provider if
you have ever had depression or other
mental health problems. You

Summary of Product characteristics

VARENICLINE- VARENICLINE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARENICLINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VARENICLINE TABLETS.
VARENICLINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Varenicline tablets are a nicotinic receptor partial agonist indicated
for use as an aid to smoking cessation
treatment. (1 and 2.1)
DOSAGE AND ADMINISTRATION
Begin varenicline tablet dosing one week before the date set by the
patient to stop smoking.
Alternatively, the patient can begin varenicline tablet dosing and
then quit smoking between days 8 and
35 of treatment. (2.1)
Starting Week: 0.5 mg once daily on days 1 to 3 and 0.5 mg twice daily
on days 4 to 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)
Consider a gradual approach to quitting smoking with varenicline
tablets for patients who are sure that
they are not able or willing to quit abruptly. Patients should begin
varenicline tablets dosing and reduce
smoking by 50% from baseline within the first four weeks, by an
additional 50% in the next four weeks,
and continue reducing with the goal of reaching complete abstinence by
12 weeks. Continue treatment
for an additional 12 weeks, for a total of 24 weeks. (2.1)
Severe Renal Impairment (estimated creatinine clearance less than 30
mL/min): Begin with 0.5 mg
once daily and titrate to 0.5 mg twice daily. For patients with
end-stage renal disease undergoing
hemodialysis, a maximum of 0.5 mg daily may be given if tolerated.
(2.2)
Consider dose reduction for patients who cannot tolerate adverse
effects. (2.1)
Another attempt at treatment is recommended for those who fail to stop
smoking or relapse when
factors contributing to the failed attempt have been addressed. (2.1)
Provide patients with ap