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warnings and cautions
5 WARNINGS AND PRECAUTIONS Systemic exposure to phenylephrine can cause elevations in blood pressure ( 5.1 ). 5.1 Elevated Blood Pressure Systemic exposure to phenylephrine can cause elevations in blood pressure. 5.2 Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti- inflammatory drugs (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patien ts 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.
6 ADVERSE REACTIONS The most common reported adverse reactions (≥2%) are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rayner Surgical Inc. at 1-877-0MIDRIA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of adult patients as seen in the combined clinical trial results from three randomized, placebo-controlled studies [see Clinical Studies ( 14 )] . Table 1: Ocular Adverse Reactions Reported by ≥ 2% of Adult Patients MedDRA Preferred Term Placebo (N=462) Omidria (N=459) n (%) n (%) Ocular Events Anterior Chamber Inflammation 102 (22%) 111 (24%) Intraocular Pressure Increased 15 (3%) 20 (4%) Posterior Capsule Opacification 16 (4%) 18 (4%) Eye Irritation 6 (1%) 9 (2%) Foreign Body Sensation in Eyes 11 (2%) 8 (2%) In a safety study that enrolled 72 pediatric patients up to 3 years old, no overall difference in safety was observed between pediatric and adult patients.