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  • CLASSES

    Mydriatics and Cycloplegics

    DEA CLASS

    Rx

    DESCRIPTION

    Combination of an alpha 1-adrenergic receptor agonist (phenylephrine) and a non-selective cyclooxygenase inhibitor (ketorolac)
    Used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing post-operative pain
    Solution must be diluted in ophthalmic irrigation solution and used during surgery

    COMMON BRAND NAMES

    Omidria

    HOW SUPPLIED

    Omidria Intraocular Sol: 1-0.3%
    Omidria Irrigation Sol: 1-0.3%
    Omidria Ophthalmic Sol: 1-0.3%

    DOSAGE & INDICATIONS

    For intraoperative miosis inhibition and reduction of postoperative ocular pain during cataract surgery or intraocular lens replacement.
    Ophthalmic dosage
    Adults

    4 mL of phenylephrine; ketorolac sterile solution is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.

    MAXIMUM DOSAGE

    Adults

    4 ml of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 ml of ophthalmic irrigation solution. Solution is used as needed during surgery.

    Geriatric

    4 ml of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 ml of ophthalmic irrigation solution. Solution is used as needed during surgery.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    ADMINISTRATION

    Ophthalmic Administration

    Ophthalmic Surgical Irrigation
    Phenylephrine; ketorolac sterile solution is only for ophthalmic irrigation during ophthalmic surgery as directed. Take care NOT to administer parenterally by any route.
    Visually inspect solution and do not use if the solution is colored or cloudy, or if it contains particulate matter.
    Phenylephrine; ketorolac injection solution must be diluted prior to intraocular use.
    Using aseptic technique, dilute 4 ml of phenylephrine; ketorolac sterile solution in 500 ml of ophthalmic irrigation solution.
    Once the phenylephrine; ketorolac solution is diluted, the storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions. Do not freeze.

    STORAGE

    Omidria:
    - Diluted medication is stable for 24 hours at 39 degrees F or for 4 hours at room temperature
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Protect from light
    - Store between 68 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Asthma, NSAID hypersensitivity, salicylate hypersensitivity

    Phenylephrine; ketorolac is contraindicated in patients with a known hypersensitivity to any of its ingredients. Use caution is patients with an NSAID hypersensitivity or a salicylate hypersensitivity or who have experienced asthma, urticaria, or other allergic reactions after taking aspirin or other NSAIDs. Reports of acute bronchospasm or exacerbation of asthma exist with use of ketorolac among patients who have either a known hypersensitivity to aspirin/nonsteroidal anti-inflammatory drugs or a past medical history of asthma.

    Cardiac disease, intravenous administration

    Systemic exposure to phenylephrine is low or undetectable following a single dose of phenylephrine; ketorolac as part of the ophthalmic irrigation solution. However, systemic exposure to phenylephrine may cause elevations in blood pressure. Take care not to inject phenylephrine; ketorolac solution via intravenous administration; the drug is for ophthalmic topical irrigant use as directed only. Elderly patients, especially those with pre-existing cardiac disease, may be more likely to experience adverse cardiovascular reactions including increased blood pressure.

    Labor, pregnancy

    Phenylephrine; ketorolac is classified as FDA pregnancy risk category C. Animal reproduction studies have not been conducted with phenylephrine; ketorolac or phenylephrine. It is also not known whether phenylephrine; ketorolac can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine; ketorolac should be used in pregnant women only if clearly needed. Because detectable ketorolac plasma concentrations are available following ocular phenylephrine; ketorolac administration, use during late pregnancy should be avoided. Ketorolac, like all NSAIDs, is a prostaglandin synthetase inhibitor and use may cause in utero constriction of the fetal ductus arteriosus. Of 40 babies born with persistent pulmonary hypertension of the newborn (PPHN), 87.5% had the presence of an NSAID in their meconium versus 24.6% of 61 infants born without PPHN; the presence of only 4 NSAIDs was examined. In addition to meconium aspiration, asphyxia, respiratory distress syndrome, and group B streptococcal pneumonia, ductus arteriosus constriction by an NSAID appears to be another predisposing factor for PPHN development, as a patent ductus arteriosus was absent in 18 of the 40 infants. Prostaglandin synthetase inhibitors also have the potential to prolong pregnancy and inhibit labor if taken during the third trimester.

    Breast-feeding

    Caution is advised when administering phenylephrine; ketorolac ophthalmic irrigation to a nursing woman. Following ocular administration of phenylephrine; ketorolac, ketorolac plasma concentrations are low to undetectable. Any detectable concentrations (e.g., 1—4.2 ng/ml) usually occur during the first 8 hours after initiation of the irrigation during surgery. Because the patient often receives postoperative ketorolac eye drops, peak detectable concentrations of roughly 15 ng/ml may occur up to 24 hours after surgical irrigation use. If used during breast-feeding, instruct the patient to closely monitor the breast-fed infant and report any adverse events that may develop. Ketorolac is excreted into breast milk based on studies of oral ketorolac (10 mg four times daily), and the calculated maximum infant dose would be equivalent to 0.4% of the weight-adjusted maternal systemic dose. The American Academy of Pediatrics (AAP) considers ketorolac to be a drug which is usually compatible with breast-feeding; however, caution is advised with systemic use. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    ocular hypertension / Delayed / 4.0-4.0

    Moderate

    ocular inflammation / Early / 24.0-24.0

    Mild

    ocular irritation / Rapid / 2.0-2.0
    foreign body sensation / Rapid / 2.0-2.0

    DRUG INTERACTIONS

    There are no drug interactions associated with Phenylephrine; Ketorolac products.

    PREGNANCY AND LACTATION

    Pregnancy

    Caution is advised when administering phenylephrine; ketorolac ophthalmic irrigation to a nursing woman. Following ocular administration of phenylephrine; ketorolac, ketorolac plasma concentrations are low to undetectable. Any detectable concentrations (e.g., 1—4.2 ng/ml) usually occur during the first 8 hours after initiation of the irrigation during surgery. Because the patient often receives postoperative ketorolac eye drops, peak detectable concentrations of roughly 15 ng/ml may occur up to 24 hours after surgical irrigation use. If used during breast-feeding, instruct the patient to closely monitor the breast-fed infant and report any adverse events that may develop. Ketorolac is excreted into breast milk based on studies of oral ketorolac (10 mg four times daily), and the calculated maximum infant dose would be equivalent to 0.4% of the weight-adjusted maternal systemic dose. The American Academy of Pediatrics (AAP) considers ketorolac to be a drug which is usually compatible with breast-feeding; however, caution is advised with systemic use. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Phenylephrine is a sympathomimetic agent and ketorolac is a nonsteroidal antiinflammatory drug (NSAID); the drugs are used together to prevent miosis and decrease pain following cataract surgery.
     
    Phenylephrine: Phenylephrine stimulates alpha-adrenergic receptors (direct effect). Stimulation of these receptors on the dilator muscle and arterioles of the conjunctiva leads to profound mydriasis and vasoconstriction, respectively.
    Ketorolac: Ketorolac is a nonsteroidal anti-inflammatory (NSAID) that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Following topical application to the eye, ketorolac inhibits miosis by inhibiting the biosynthesis of ocular prostaglandins. Prostaglandins play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In the eye, prostaglandins also have been shown to disrupt the blood-aqueous humor barrier, cause vasodilation, increase vascular permeability, promote leukocytosis, and increase intraocular pressure (IOP). The degree of ocular inflammatory response is correlated with prostaglandin-induced increases in ciliary epithelium permeability. When applied topically to the eye, NSAIDs inhibit the synthesis of prostaglandins in the iris, ciliary body, and conjunctiva. Thus, NSAIDs may prevent many of the manifestations of ocular inflammation. Ketorolac does not affect intraocular pressure or tonographic aqueous outflow resistance and does not interfere with the action of acetylcholine administered during ocular surgery. Ketorolac also does not prevent increases in intraocular pressure or decreases in aqueous outflow induced by topical corticosteroids.

    PHARMACOKINETICS

    Phenylephrine; ketorolac is administered as part of an ophthalmic irrigation solution.

    Other Route(s)

    Ophthalmic Route
    In a pharmacokinetic study evaluating phenylephrine; ketorolac, systemic exposure to both phenylephrine and ketorolac was low or undetectable after ophthalmic irrigation.
    Phenylephrine: A single-dose of phenylephrine; ketorolac as part of the irrigation solution was administered in 14 patients during lens replacement surgery. The volume of irrigation solution used during surgery ranged between 150 ml to 300 ml (median 212.5 ml). During the first 2 hours after the initiation of phenylephrine; ketorolac, detectable phenylephrine plasma concentrations were observed in one of 14 subjects (range 1.2 to 1.4 ng/ml). The observed phenylephrine plasma concentrations could not be distinguished from the preoperative administration of phenylephrine 2.5% ophthalmic solution prior to exposure to phenylephrine; ketorolac.
    Ketorolac: Ketorolac plasma concentrations were detected in 10 of 14 subjects (range 1 to 4.2 ng/ml) during the first 8 hours after the initiation of phenylephrine; ketorolac. The maximum ketorolac concentration was 15 ng/ml at 24 hours after the initiation of phenylephrine; ketorolac, which may have been attributable to application of postoperative ketorolac ophthalmic solution.