Acular eent

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

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

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

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

1 drop (250 mg) of a 0.5% solution in the affected eye(s) 4 times daily.1 141 142

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

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

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

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

Contraindications

Known hypersensitivity to ketorolac tromethamine or any ingredient in the formulation.1 154 155

Warnings/Precautions

Warnings

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

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

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.)

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

Category C.1 154 155 Avoid use in the third trimester because of possible premature closure of the ductus arteriosus.1 154 155

Distributed into milk after systemic administration.2 14 21 22 48 85 Caution if used in nursing women.1 154 155

Safety and efficacy not established in children <3 years of age.1 154 155

No substantial differences in safety and efficacy relative to younger adults.1 154 155

Common Adverse Effects

Ocular stinging and burning.1 154 155

No formal drug interaction studies to date.1 154 155

Specific Drugs

• 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.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.