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
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