Class: Nonsteroidal Anti-inflammatory Agents
ATC Class: S01BC05
VA Class: OP300
CAS Number: 74103-07-4
Brands: Acular
Introduction
Prototypical NSAIA; a pyrrolizine carboxylic acid derivative.1 2 3 4 14 21 22 25 26 27 28
Uses for Ketorolac Tromethamine
Conjunctivitis
Temporary relief of ocular itching due to seasonal allergic (hay fever, pollinosis) conjunctivitis.1 141 142 143
Postoperative Ocular Inflammation
Management of postoperative inflammation associated with cataract extraction.1 11 17 18 19 61 85 110 147
Postoperative Ocular Pain
Reduction of ocular pain and burning/stinging following corneal refractive surgery and photorefractive keratectomy (PRK).155 156
Ketorolac tromethamine 0.5% preservative-free ophthalmic solution is used for the reduction of ocular pain and photophobia following incisional refractive surgery.154
Cystoid Macular Edema
Treatment, with or without concomitant topical corticosteroid therapy, to prevent or relieve postoperative cystoid macular edema associated with cataract extraction†.61
Has been used for the active treatment of chronic aphakic or pseudophakic cystoid macular edema†.14 20 23
Inhibition of Intraoperative Miosis
Has been used prophylactically before ocular surgery to prevent or reduce intraoperative miosis†.53 81 106 107 108 110 137 139
Ketorolac Tromethamine Dosage and Administration
Administration
Ophthalmic Administration
Apply topically to the eye as an ophthalmic solution.1 154 155
Avoid contamination of the solution container.154
Do not administer while wearing contact lenses.1 154 155
Preservative-free solution is for single use only in one or both eyes; use immediately after opening and discard any unused portion immediately after administration.154
Has been safely administered with other ophthalmic medications (e.g., antibiotics, β-blockers, carbonic anhydrase inhibitors, cycloplegics, mydriatics).1
Dosage
Available as ketorolac tromethamine; dosage expressed in terms of the salt.154 155
Pediatric Patients
Conjunctivitis
Ophthalmic
Children ≥3 years of age: 1 drop (250 mg) of a 0.5% solution in the affected eye(s) 4 times daily.1 141 142
Postoperative Ocular Inflammation
Ophthalmic
Children ≥3 years of age: 1 drop (250 mcg) of a 0.5% solution in the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery and typically continuing for 2 weeks after surgery.1
Postoperative Ocular Pain
Ophthalmic
Children ≥3 years of age undergoing ocular incisional refractive surgery: 1 drop (250 mcg) of a 0.5% preservative-free solution 4 times daily in the eye(s) that underwent surgery as needed for up to 3 days after surgery.154
Children ≥3 years of age undergoing corneal refractive surgery: 1 drop (200 mcg) of a 0.4% solution 4 times daily in the eye(s) that underwent surgery as needed for up to 4 days after surgery.155
Adults
Conjunctivitis
Ophthalmic
1 drop (250 mg) of a 0.5% solution in the affected eye(s) 4 times daily.1 141 142
Postoperative Ocular Inflammation
Ophthalmic
1 drop (250 mcg) of a 0.5% solution in the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery and typically continuing for 2 weeks after surgery.1
Postoperative Ocular Pain
Ophthalmic
Patients undergoing ocular incisional refractive surgery: 1 drop (250 mcg) of a 0.5% preservative-free solution 4 times daily in the eye(s) that underwent surgery as needed for up to 3 days after surgery.154
Patients undergoing corneal refractive surgery: 1 drop (200 mcg) of a 0.4% solution 4 times daily in the eye(s) that underwent surgery as needed for up to 4 days after surgery.155
Cystoid Macular Edema
Postoperative Cystoid Macular Edema†
Ophthalmic
1–2 drops (250–500 mcg) of a 0.5% solution in the eye(s) undergoing surgery every 6–8 hours beginning 24 hours prior to surgery and continuing for 3–4 weeks after surgery.11 17 18 19 61 85
Chronic Aphakic or Pseudophakic Cystoid Macular Edema†
Ophthalmic
1–2 drops (250–500 mcg) of a 0.5% solution in the affected eye(s) 4 times daily for 2–3 months.20 23
Cautions for Ketorolac Tromethamine
Contraindications
Known hypersensitivity to ketorolac tromethamine or any ingredient in the formulation.1 154 155
Warnings/Precautions
Warnings
Hematologic Effects
May inhibit platelet aggregation and prolong bleeding time.1 137 154 155
May increase bleeding (e.g., hyphemas) of ocular tissues in patients undergoing ocular surgery.1 24 53 106 154 155
Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1 154 155
Sensitivity Reactions
Cross-sensitivity
Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.1 154 155 Use with caution in patients with history of hypersensitivity to these drugs.1 54 55 56 57 58 59 85 117 118 154 155
General Precautions
Wound Healing Complications
Possible slow or delayed wound healing; may be potentiated with concomitant adminsitration of topical NSAIAs or topical corticosteroids.1 154 155 (See Specific Drugs under Interactions.)
Ocular Effects
Use may result in keratitis.1 85 139 154 155 In susceptible patients, continued use may result in epithelial breakdown, corneal thinning, erosion, ulceration, or perforation, which may be sight-threatening.1 154 155
If manifestations of corneal epithelial breakdown occur, discontinue immediately and closely monitor corneal health.1 154 155
Increased risk of sight-threatening, adverse corneal effects in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time; use with caution in such patients.1 154 155
Use >24 hours prior to surgery or >14 days postoperatively may precipitate or exacerbate adverse corneal effects.1 154 155
Specific Populations
Pregnancy
Category C.1 154 155 Avoid use in the third trimester because of possible premature closure of the ductus arteriosus.1 154 155
Lactation
Distributed into milk after systemic administration.2 14 21 22 48 85 Caution if used in nursing women.1 154 155
Pediatric Use
Safety and efficacy not established in children <3 years of age.1 154 155
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults.1 154 155
Common Adverse Effects
Ocular stinging and burning.1 154 155
Interactions for Ketorolac Tromethamine
No formal drug interaction studies to date.1 154 155
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Corticosteroids, ophthalmic | Possible additive effects on delaying wound healing1 154 155 Additive ocular anti-inflammatory activity1 154 155 | Concomitant use may increase the potential for wound healing complications1 154 155 Potential for additive effects used to therapeutic advantage11 18 81 |
Ketorolac Tromethamine Pharmacokinetics
Absorption
Bioavailability
Extent of ocular and systemic absorption not fully elucidated;1 however, limited concentrations are achieved systemically following topical application to the eye relative to usual oral or parenteral doses.1 14 16 18
Following topical application to the eye, plasma ketorolac concentrations were detectable (range: 10.7–22.5 ng/mL) in about 20% of patients.1 154 155
Distribution
Extent
Distribution into human ocular tissues and fluids not fully characterized to date.1 14 78
Ketorolac crosses the placenta21 28 46 47 78 and is distributed into milk following systemic administration.2 14 21 22 48 78
Plasma Protein Binding
>99%.2 14 28 45 49 78
Stability
Storage
Ophthalmic
0.4% Solution
15–25°C.155
0.5% Solution
Light-resistant containers at 15–30°C.1 154
ActionsActions
Inhibits synthesis of certain ocular prostaglandins (e.g., PGE2) in iris, ciliary body, and conjunctiva by inhibiting cyclooxygenase-1 (COX-1) and -2 (COX-2).1 2 4 6 10 21 28 40 62 66 68 69 70 71 72 73 77 80 81 110 154 155
Substantially reduces aqueous humor concentrations of these prostaglandins.1 80 81 110 121 122 123 126 128
Does not appear to inhibit lipoxygenase;21 81 does not inhibit aspects of inflammation mediated by leukotrienes.81 119 137
Advice to Patients
Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1 154 155
Importance of removing contact lenses before administration.1 154 155
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 154 155
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1 154 155
Importance of informing patients of other important precautionary information.1 154 155 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.4% | Acular LS (with benzalkonium chloride) | Allergan |
0.5% | Acular (with benzalkonium chloride) | Allergan | ||
Acular PF (preservative-free) | Allergan |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Acular 0.5% Solution (ALLERGAN): 3/$59.34 or 9/$158.96
Acular 0.5% Solution (ALLERGAN): 5/$132.07 or 15/$370.21
Acular 0.5% Solution (ALLERGAN): 10/$236.03 or 30/$687.45
Acular LS 0.4% Solution (ALLERGAN): 5/$133.52 or 15/$400.6
Acuvail 0.45% Solution (ALLERGAN): 30/$133.11 or 90/$374.39
Ketorolac Tromethamine 0.4% Solution (FALCON PHARMACEUTICALS): 5/$75.99 or 15/$199.96
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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