Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
04/15/2008
Trade Name:
Patanase Nasal Spray
Generic Name or Proper Name (*):
olopatadine hydrochloride
Indications Studied:
Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older
Label Changes Summary:
Safety and effectiveness in children below the age of 12 years have not been established Symptoms of antihistamine overdose in children may initially include agitation and restlessness followed by drowsiness Efficacy and safety were evaluated in 3 clinical trials of 2 weeks duration in adult and adolescent patients, 12 years of age and older, with symptoms of SAR Dosage and administration information provided for children 12 years and older New indication, dosage form, dosing regimen, and route of administration
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Alcon Research, Ltd.
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
-
-