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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Alcon
NNPS:
TRUE'
Therapeutic Category:
Ophthalmologic hypotensive
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