Introductory Information
Prototypical NSAIA; a pyrrolizine carboxylic acid derivative.1, 2, 3, 4, 14, 21, 22, 25, 26, 27, 28
Class: 52:08.20 Nonsteroidal Anti-inflammatory Agents; op300 (VA primary)
Brands: Acular
Generic Name: Ketorolac Tromethamine
CAS Number: 74103-07-4
Generic Name: Ketorolac
CAS Number: 74103-06-3
Investigational Drug Number: RS 37619
Uses
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
Has been used for the active treatment of chronic aphakic or pseudophakic cystoid macular
edema
.14, 20, 23
Has been used prophylactically before ocular surgery to prevent or reduce intraoperative
miosis
.53, 81, 106, 107, 108, 110, 137, 139
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
Interaction
Possible additive effects on
delaying wound healing1, 154,
155
Comments
Concomitant use may increase the
potential for wound healing
complications1, 154, 155
Potential for additive effects used to
therapeutic advantage11, 18, 81
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
15-25C.155
0.5% Solution
Light-resistant containers at 15-30C.1, 154
Actions
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
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. For the most current and up-to-date pricing
information, please visit www.drugstore.com. 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
Use is not currently included in the labeling approved by the US Food and Drug
Administration.
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