Ketorolac Tromethamine 0.5% 10mL

NDC: 69315-322-10

Ketorolac Tromethamine 0.5% Ophthalmic Solution, 10 mL — Leading Pharma, LLC

Active ingredients	Ketorolac tromethamine 0.5% (5 mg/mL)
Dosage form	Sterile ophthalmic solution
Route	Topical ophthalmic
Size	10 mL
Manufacturer	Leading Pharma, LLC
NDC	69315-322-10

Indications and Usage

Temporary relief of ocular itching due to seasonal allergic conjunctivitis, and treatment of postoperative inflammation in patients who have undergone cataract extraction.

Dosage and Administration

For allergic conjunctivitis, instill one drop four times a day. For postoperative inflammation, instill one drop four times daily beginning 24 hours after cataract surgery and continuing through the first two postoperative weeks.

Warnings and Precautions

• May slow or delay corneal healing; risk of corneal thinning, erosion, ulceration, or perforation with continued use
• May increase ocular bleeding, including hyphema
• Potential for cross-sensitivity to aspirin and other NSAIDs
• Avoid use with 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 on 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) and protect from light.

How Supplied

Sterile ophthalmic solution supplied in a plastic dropper bottle, including a 10 mL fill.

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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