Phenylephrine And Ketorolac
Generic Name: phenylephrine and ketorolac
Brand Names:
Omidria
11 DESCRIPTION Omidria is a sterile aqueous solution, containing the α 1 -adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine, for addition to ocular irrigating solution.
Overview
11 DESCRIPTION Omidria is a sterile aqueous solution, containing the α 1 -adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine, for addition to ocular irrigating solution.
Uses
1 INDICATIONS AND USAGE Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
Dosage
2 DOSAGE AND ADMINISTRATION Omidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure for a single patient. The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions. Do not use if the solution is cloudy or if it contains particulate matter. Each vial of OMIDRIA must be diluted prior to use for administration to a single patient undergoing cataract surgery or intraocular lens replacement. Dilute 4 mL of OMIDRIA in 500 mL of ocular irrigating solution.
Side Effects
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.
Warnings
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. 4 CONTRAINDICATIONS Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. Hypersensitivity to any component of this product ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on Omidria use in pregnant women or animals to inform any drug-associated risks. Oral administration of ketorolac to rats during late gestation produced dystocia and increased pup mortality at a dose 740-times the plasma exposure at the recommended human ophthalmic dose (RHOD). Since human systemic exposure to Omidria following a lens replacement procedure is low (see Clinical Pharmacology (12.3)], the applicability of animal findings to the risk of Omidria in humans during pregnancy is unclear.
Storage
Storage: Store at 20˚ to 25˚C (68˚ to 77˚F). Protect from light.
Frequently Asked Questions
What is Phenylephrine And Ketorolac used for?▼
1 INDICATIONS AND USAGE Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
What are the side effects of Phenylephrine And Ketorolac?▼
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.
Can I take Phenylephrine And Ketorolac during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on Omidria use in pregnant women or animals to inform any drug-associated risks. Oral administration of ketorolac to rats during late gestation produced dystocia and increased pup mortality at a dose 740-times the plasma exposure at the recommended human ophthalmic dose (RHOD). Since human systemic exposure to Omidria following a lens replacement procedure is low (see Clinical Pharmacology (12.3)], the applicability of animal findings to the risk of Omidria in humans during pregnancy is unclear.
What are the important warnings for Phenylephrine And Ketorolac?▼
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. 4 CONTRAINDICATIONS Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. Hypersensitivity to any component of this product ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.