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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon Research, Ltd.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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