Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  10/30/2007
 
Trade Name:  Combigan 0.2%/0.5% ophthalmic solution
 
Generic Name or Proper Name (*):  brimonidine tartrate/timolol maleate
 
Indications Studied:  Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
 
Label Changes Summary:  Safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2  7 years old Not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants Safety and effectiveness have not been studied in children below the age of two years New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  TRUE'
 
Therapeutic Category:  Ophthalmologic hypotensive
 
-
-