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Omidria

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Omidria

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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

Pregnancy

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.

Clinical Considerations

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.

Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when Omidria is administered to nursing women.

Pediatric Use

Safety and effectiveness of Omidria in pediatric patients below the age of 18 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and adult patients.

Last reviewed on RxList: 6/16/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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