ketorolac tromethamine

Warnings and Precautions ( 5.5 ) 9/2025

Before you use Ketorolac Tromethamine Ophthalmic solution 0.5% for the first time: 1.Check to make sure that the tamper evident ring between the bottle and the cap is not broken ( See Figure A). If the tamper evident ring is broken or missing, contact your pharmacist. [Img-fig-a] 2.Tear off the tamper evident ring ( See Figure B). [Img-fig-b] 3.To open the bottle, remove the cap by turning it in the counterclockwise direction ( See Figure C). [Img-fig-c] This Instructions for Use has been approved by the U.S. Food and Drug Administration. Rev.10/2021

Ketorolac tromethamine ophthalmic solution 0.5% is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution 0.5% is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

2 DOSAGE AND ADMINISTRATION For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ketorolac tromethamine ophthalmic solution 0.5% to the affected eye(s) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, apply one drop of ketorolac tromethamine ophthalmic solution 0.5% to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. ( 2.1 ) 2.1 Recommended Dosage Temporary Relief of Ocular Itching Due to Seasonal Allergic Conjunctivitis The recommended dosage of ketorolac tromethamine ophthalmic solution 0.5% is one drop four times a day to the affected eye(s) for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Treatment of Postoperative Inflammation in Patients Who Have Undergone Cataract Extraction Apply one drop of ketorolac tromethamine ophthalmic solution 0.5% to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period for the treatment of postoperative inflammation in patients who have undergone cataract extraction. 2.2 Use with Other Topical Ophthalmic Medications Ketorolac tromethamine ophthalmic solution 0.5% has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

3 DOSAGE FORMS AND STRENGTHS 10 mL size bottle filled with 3 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL) 10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL) 10 mL size bottle filled with 10 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL) Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. ( 3 ) 10 mL size bottle filled with 3 mL of solution 10 mL size bottle filled with 5 mL of solution 10 mL size bottle filled with 10 mL of solution

4 CONTRAINDICATIONS Ketorolac tromethamine ophthalmic solution 0.5% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.1) ] . Hypersensitivity to any component of this product. ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Delayed Healing [see Warnings and Precautions ( 5.1 )] • Cross-Sensitivity or Hypersensitivity [see Warnings and Precautions ( 5.2 )] • Increased Bleeding Time [see Warnings and Precautions ( 5.3 )] • Corneal Effects [see Warnings and Precautions ( 5.4 )] The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials. Other adverse reactions occurring approximately 1% to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritus), corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections. Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision). 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug. Eye Disorders: corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. Respiratory, Thoracic and Mediastinal Disorders: bronchospasm or exacerbation of asthma.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects. Pregnancy Category C Pregnancy Category C: Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x4 drops x 2 eyes) to affected eyes on a mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Ketorolac tromethamine ophthalmic solution 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ketorolac tromethamine ophthalmic solution 0.5% during late pregnancy should be avoided. 8.3 Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution 0.5% is administered to a nursing woman. 8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 2 have not been established. 8.5 Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

12.1 Mechanism of Action Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

11 DESCRIPTION Ketorolac tromethamine ophthalmic solution, 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structural formula: The molecular formula of ketorolac tromethamine ophthalmic solution, 0.5% is C 15 H 13 NO 3 •C 4 H 11 NO 3 . Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution, 0.5% contains: Active: Ketorolac Tromethamine 0.5%. Inactives: Edetate Disodium 0.1%; Octoxynol 40; Sodium Chloride; Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.8 to 7.4); Water for Injection. Preservative: Benzalkonium Chloride 0.01%. Structural Formula

HOW SUPPLIED Ketorolac Tromethamine Ophthalmic Solution is supplied sterile in white LDPE plastic bottles with natural droppers and gray short skirt caps as follows: 5 mL in l0 mL bottle - NDC 63187-628-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Rx only Manufactured by: Akorn, Inc. Lake Forest, IL 60045 KR00N Rev.05/12 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320