"For adults and children who undergo cataract surgery, implantation of an artificial lens is the standard of care. But a clinical trial suggests that for most infants, surgery followed by the use of contact lenses for several years â€” and an eventu"...
Elevated Blood Pressure
Systemic exposure of phenylephrine can cause elevations in blood pressure.
Cross-Sensitivity Or Hypersensitivity
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatories (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patients who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma. Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these drugs.
Use In Specific Populations
Teratogenic Effects - Pregnancy Category C
Animal reproduction studies have not been conducted with Omidria or phenylephrine. It is also not known whether Omidria can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Omidria should be used in pregnant women only if clearly needed.
Ketorolac, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses produced systemic exposure that is 1150 times and 4960 times the plasma exposure (based on Cmax) at the recommended human ophthalmic dose (RHOD), respectively. When administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (740 times the plasma exposure at the RHOD), ketorolac produced dystocia and increased pup mortality.
Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Detectable ketorolac plasma concentrations are available following ocular Omidria administration [see CLINICAL PHARMACOLOGY]. The use of Omidria during late pregnancy should be avoided.
Because many drugs are excreted in human milk, caution should be exercised when Omidria is administered to nursing women.
Safety and effectiveness of Omidria in pediatric patients below the age of 18 years have not been established.
No overall differences in safety or effectiveness have been observed between elderly and adult patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/16/2014
Additional Omidria Information
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