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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:  06/22/2010
 
Trade Name:  Isopto Carpine
 
Generic Name or Proper Name (*):  pilocarpine hydrochloride
 
Indications Studied:  Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; management of acute angle closure glaucoma; prevention of postoperative elevated IOP associated with laser surgery and induction of miosis
 
Label Changes Summary:  Safety and effectiveness in pediatric patients have been established Not recommended in pediatric patients diagnosed with glaucoma due to anterior segment dysgenesis or uveitis Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. Adverse events similar to adults New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon
 
NNPS:  TRUE'
 
Therapeutic Category:  Ophthalmologic hypotensive
 
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