MedPath

Varenicline

Generic Name
Varenicline
Brand Names
Champix, Chantix, Tyrvaya
Drug Type
Small Molecule
Chemical Formula
C13H13N3
CAS Number
249296-44-4
Unique Ingredient Identifier
W6HS99O8ZO

Overview

Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors. On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.

Background

Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors. On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.

Indication

For use as an aid in smoking cessation. Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.

Associated Conditions

  • Dry Eye Syndrome (DES)

FDA Approved Products

Varenicline
Manufacturer:Ajanta Pharma USA Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2024/01/30
NDC:27241-174
Varenicline
Manufacturer:Ajanta Pharma USA Inc.
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2024/01/30
NDC:27241-173
VARENICLINE
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2024/04/02
NDC:72162-2218
Varenicline
Manufacturer:Mylan Pharmaceuticals Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/04/15
NDC:0378-5090
VARENICLINE
Manufacturer:Lupin Pharmaceuticals, Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2024/03/27
NDC:70748-128

Singapore Approved Products

Champix Tablet 1mg
Manufacturer:Pfizer Italia S.r.l.
Form:TABLET, FILM COATED
Strength:1 mg/tablet
Online:Yes
Approved: 2007/08/01
Approval:SIN13323P
Champix Tablet Starter Pack
Manufacturer:Pfizer Italia S.r.l.
Form:TABLET, FILM COATED
Strength:0.5 mg
Online:Yes
Approved: 2007/08/01
Approval:SIN13322P
Champix Tablet Starter Pack
Manufacturer:Pfizer Italia S.r.l.
Form:TABLET, FILM COATED
Strength:1 mg
Online:Yes
Approved: 2007/08/01
Approval:SIN13322P

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