Ketorolac Tromethamine 0.5% 10mL

Ketorolac Tromethamine 0.5% Ophthalmic Solution, 10 mL

NDC: 42571-137-26

Product Details

Active Ingredient	Ketorolac tromethamine 0.5% (5 mg/mL)
Dosage Form	Sterile ophthalmic solution
Route	Topical ophthalmic
Package Size	10 mL
Manufacturer	Micro Labs
NDC	42571-137-26

Indications and Usage

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

Dosage and Administration

• Allergic conjunctivitis: Instill one drop in the affected eye(s) four times daily.
• Postoperative inflammation: Instill one drop in the affected eye(s) four times daily, beginning 24 hours after cataract surgery and continuing through the first two postoperative weeks, as directed by the prescribing healthcare professional.

Warnings and Precautions

• Corneal effects: Topical NSAIDs may slow or delay corneal healing. Continued use may increase the risk of corneal thinning, erosion, ulceration, or perforation.
• Ocular bleeding: May increase bleeding time or ocular bleeding, including hyphema.
• Cross-sensitivity: Potential cross-sensitivity exists with aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).
• Contact lenses: Avoid use while wearing contact lenses unless otherwise directed by the prescribing healthcare professional and product labeling.

Contraindications

Contraindicated in patients with known hypersensitivity to any component of the formulation.

Adverse Reactions

The most common adverse reactions include transient stinging and burning upon instillation. Ocular irritation, allergic reactions, and superficial keratitis may also occur.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

How Supplied

Sterile ophthalmic solution supplied in a plastic dropper bottle containing 10 mL.

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Professional use only.

Clinical information is summarized from FDA-approved prescribing information (Structured Product Labeling). Refer to the full prescribing information via DailyMed for complete details.

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