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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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