Ketorolac Ophthalmic Solution 0.5% 5mL

NDC: 69315-322-05

Ketorolac Tromethamine 0.5% Ophthalmic Solution, 5 mL — Leading Pharma LLC

Product Details	Description
Active ingredients	Ketorolac tromethamine 0.5% (5 mg/mL)
Dosage form	Ophthalmic solution
Route	Topical ophthalmic
Size	5 mL
Manufacturer	Leading Pharma LLC
NDC	69315-322-05

Indications and Usage

A nonsteroidal anti-inflammatory drug (NSAID) indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis and for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Dosage and Administration

For allergic conjunctivitis, instill one drop in the affected eye(s) four times daily. For postoperative inflammation, instill one drop in the affected eye four times daily, beginning 24 hours after cataract surgery and continuing through the first two weeks. Separate administration of other topical eye medications by at least five minutes.

Warnings and Precautions

• May slow or delay corneal healing.
• Corneal effects, including keratitis, thinning, erosion, ulceration, and perforation, have been reported.
• May increase bleeding time due to interference with platelet aggregation.
• Do not administer while wearing contact lenses.

Contraindications

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

Adverse Reactions

The most common adverse reactions are transient stinging and burning upon instillation. Other reactions include corneal edema, iritis, ocular inflammation, and, rarely, corneal ulceration or perforation.

Storage and Handling

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

How Supplied

Supplied as a sterile ophthalmic solution in a 5 mL bottle.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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