Get your patient on Diclofenac - Diclofenac Sodium solution/ Drops (Diclofenac Sodium)

One drop of Diclofenac sodium ophthalmic solution, 0.1% should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

One or two drops of Diclofenac sodium ophthalmic solution, 0.1% should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.

Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Diclofenac sodium ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Diclofenac sodium ophthalmic solution, 0.1%, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.

The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection and vomiting.

The following reactions have been identified during postmarketing use of topical diclofenac sodium ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical diclofenac sodium ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration and epithelilal breakdown (see PRECAUTIONS , General ).

TO REPORT SUSPECTED ADVERSE REACTIONS , contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Diclofenac sodium is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. It is thought to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of prostaglandins.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of Diclofenac sodium ophthalmic solution, 0.1% to each eye were below the limit of quantification (10 ng/mL) over a 4-hour period. This study suggests that limited, if any, systemic absorption occurs with Diclofenac sodium ophthalmic solution, 0.1%.

Postoperative Anti-Inflammatory Effects
In two double-masked, controlled, efficacy studies of postoperative inflammation, a total of 206 cataract patients were treated with Diclofenac sodium ophthalmic solution, 0.1% and 103 patients were treated with vehicle placebo. Diclofenac sodium ophthalmic solution, 0.1% was favored over vehicle placebo over a 2-week period for the clinical assessments of inflammation as measured by anterior chamber cells and flare.

In double-masked, controlled studies of corneal refractive surgery (radial keratotomy (RK) and laser photorefractive keratectomy (PRK)) patients were treated with Diclofenac sodium ophthalmic solution, 0.1% and/or vehicle placebo. The efficacy of Diclofenac sodium ophthalmic solution, 0.1% given before and shortly after surgery was favored over vehicle placebo during the 6-hour period following surgery for the clinical assessments of pain and photophobia. Patients were permitted to use a hydrogel soft contact lens with Diclofenac sodium ophthalmic solution, 0.1% for up to three days after PRK.