OMIDRIA- phenylephrine and ketorolac injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV), KETOROLAC (UNII: YZI5105V0L) (KETOROLAC - UNII:YZI5105V0L)

Available from:

Omeros Corporation

INN (International Name):

PHENYLEPHRINE

Composition:

PHENYLEPHRINE 10.16 mg in 1 mL

Administration route:

INTRAOCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with a known hypersensitivity to any of its ingredients. 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. Omidria should be used during pregnancy only if the potential benefit justifies the p

Product summary:

Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% is supplied in a clear, 5-mL glass, single-patient-use vial containing 4 mL of sterile solution, for addition to ocular irrigating solution. Omidria is supplied in a multi-pack containing: 4 vials : NDC 62225-600-04 or 10 vials: NDC 62225-600-10 Storage: Store at 20˚ to 25˚C (68˚ to 77˚F). Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

OMIDRIA- PHENYLEPHRINE AND KETOROLAC INJECTION, SOLUTION, CONCENTRATE
OMEROS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMIDRIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMIDRIA.
OMIDRIA (PHENYLEPHRINE AND KETOROLAC INTRAOCULAR SOLUTION) 1% / 0.3%, FOR
ADDITION TO
OCULAR IRRIGATING SOLUTION
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
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 AND ADMINISTRATION
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.
Irrigation solution is to be used as needed
for the surgical procedure. ( 2)
DOSAGE FORMS AND STRENGTHS
Intraocular solution containing phenylephrine 10.16 mg/mL (1%) and
ketorolac 2.88 mg/mL (0.3%) for use
in a single patient. ( 3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product ( 4)
WARNINGS AND PRECAUTIONS
Systemic exposure to phenylephrine may cause elevations in blood
pressure. ( 5.1)
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 OMEROS CORPORATION AT
1-844-OMEROS1
OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Elevated Blood Pressure
5.2 Cross-Sensitivity or Hypersensitivity
6 ADV