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U.S. Department of Health and Human Services

Safety

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Combigan (brimonidine tartrate/timolol maleate) 0.2%/0.5% ophthalmic solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

CONTRAINDICATIONS

Neonates and Infants (Under the Age of 2 Years)
  • Combiganis contraindicated in neonates and infants (under the age of 2 years).
 

WARNINGS AND PRECAUTIONS

Ocular Hypersensitivity
  • Ocular hypersensitivity reactions have been reported with brimonidine tartrate ophthalmic solutions 0.2%, with some reported to be associated with an increase in intraocular pressure.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Hypersensitivity
  • In infants, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported.
 

OVERDOSAGE

  • Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine ophthalmic solutions as part of medical treatment of congenital glaucoma or by accidental oral ingestion.
 

 

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