Diclofenac Sodium 0.1% 5mL

NDC: 61314-014-05

Diclofenac Sodium 0.1% Ophthalmic Solution, 5 mL — Sandoz

Active ingredients	Diclofenac sodium 0.1% (1 mg/mL)
Dosage form	Ophthalmic solution
Route	Topical ophthalmic
Size	5 mL
Manufacturer	Sandoz
NDC	61314-014-05

Indications and Usage

Treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.

Dosage and Administration

After cataract surgery, instill one drop in the affected eye four times daily beginning 24 hours after surgery and continuing through the first two weeks. For corneal refractive surgery, apply one or two drops within the hour before surgery, one or two drops within 15 minutes after surgery, and then continue four times daily for up to three days.

Warnings and Precautions

• May increase bleeding time and cause ocular tissue bleeding during surgery
• Potential for cross-sensitivity to aspirin and other NSAIDs
• May slow or delay corneal wound healing
• Refractive stability has not been established; monitor patients accordingly

Contraindications

Contraindicated in patients hypersensitive to any component of the product.

Adverse Reactions

The most common adverse reactions are transient burning and stinging, keratitis, elevated intraocular pressure, and lacrimation.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F); protect from light.

How Supplied

Sterile solution in plastic dropper-tip bottles, supplied in a 5 mL size.

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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