Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Ketorolac tromethamine ophthalmic solution, 0.5% is supplied sterile in a white LDPE plastic bottle, a natural dropper tip and a gray polypropylene cap as follows: 5 mL in 8 mL bottle NDC 61314-126-05 10 mL in 10 mL bottle NDC 61314-126-10 Storage: Store at 15° to 30°C (59° to 86°F). Protect from light. FOR TOPICAL OPHTHALMIC USE ONLY; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-126-05 Ketorolac Tromethamine Ophthalmic Solution 0.5% Rx Only STERILE 5 mL SANDOZ carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Ketorolac tromethamine ophthalmic solution, 0.5% is supplied sterile in a white LDPE plastic bottle, a natural dropper tip and a gray polypropylene cap as follows: 5 mL in 8 mL bottle NDC 61314-126-05 10 mL in 10 mL bottle NDC 61314-126-10 Storage: Store at 15° to 30°C (59° to 86°F). Protect from light. FOR TOPICAL OPHTHALMIC USE ONLY
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 61314-126-05 Ketorolac Tromethamine Ophthalmic Solution 0.5% Rx Only STERILE 5 mL SANDOZ carton
Overview
Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains 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 contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH. chemicalstructure
Indications & Usage
Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for: • The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 ) • The treatment of inflammation following cataract surgery. ( 1 ) •
Dosage & Administration
• For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ketorolac tromethamine ophthalmic solution 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 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 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 should be applied 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 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.
Warnings & Precautions
• Delayed healing ( 5.1 ) • Cross-sensitivity or hypersensitivity ( 5.2 ) • Increased bleeding time due to interference with thrombocyte aggregation ( 5.3 ) • Corneal effects including keratitis ( 5.4 ) 5.1 Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.2 Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine ophthalmic solution in patients who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.3 Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ketorolac tromethamine ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time. 5.4 Corneal Effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that 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 may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. 5.5 Risk of Contamination Avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. 5.6 Contact Lens Wear Ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.
Contraindications
Ketorolac tromethamine ophthalmic solution 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 )
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.
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