Diclofenac Ophthalmic Solution

Diclofenac Sodium Ophthalmic is contraindicated in patients who are hypersensitive to any component of the medication.

General

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Use of topical NSAIDs may result in keratitis. In some susceptible patients continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal infiltrates, corneal erosion, corneal ulceration, and corneal perforation. These events may be sight-threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients experiencing complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period-of-time may be at increased risk for corneal adverse events, which may become sight-threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for occurrence and severity of corneal adverse events.

It is recommended that Diclofenac Sodium Ophthalmic, like other NSAIDs, be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Results from clinical studies indicate that Diclofenac Sodium Ophthalmic has no significant effect upon ocular pressure. However, elevations in intraocular pressure may occur following cataract surgery.

Information for Patients

Except for the use of a bandage hydrogel soft contact lens during the first 3 days following refractive surgery, Diclofenac Sodium Ophthalmic should not be used by patients currently wearing soft contact lenses due to adverse events that have occurred in other circumstances.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in rats given Diclofenac Sodium in oral doses up to 2 mg/kg/day (approximately 500 times the human topical ophthalmic dose) revealed no significant increases in tumor incidence. A 2-year carcinogenicity study conducted in mice employing oral Diclofenac Sodium up to 2 mg/kg/day did not reveal any oncogenic potential. Diclofenac Sodium did not show mutagenic potential in various mutagenicity studies including the Ames test. Diclofenac Sodium administered to male and female rats at 4 mg/kg/day (approximately 1000 times the human topical ophthalmic dose) did not affect fertility.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

PREGNANCY

Teratogenic Effects

Pregnancy Category C. Reproduction studies performed in mice at oral doses up to 5,000 times (20 mg/kg/day) and in rats and rabbits at oral doses up to 2,500 times (10 mg/kg/day) the human topical dose have revealed no evidence of teratogenicity due to Diclofenac Sodium despite the induction of maternal toxicity and fetal toxicity. In rats, maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. Diclofenac Sodium has been shown to cross the placental barrier in mice and rats. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-teratogenic Effects

Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Diclofenac Sodium Ophthalmic during late pregnancy should be avoided.

Nursing Women

It is not known whether topical ophthalmic administration of Diclofenac Sodium Ophthalmic could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Overdosage will not ordinarily cause acute problems. If Diclofenac Sodium Ophthalmic is accidentally ingested, fluids should be taken to dilute the medication.

Cataract Surgery

One drop of Diclofenac Sodium Ophthalmic should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.

Corneal Refractive Surgery

One or two drops of Diclofenac Sodium Ophthalmic 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.

Diclofenac Sodium Ophthalmic 0.1% (1 mg/mL) Sterile Solution is supplied in a low-density polyethylene (LDPE) white bottle with a LDPE Dropper Tip and a gray cap. The 2.5 mL fill and the 5 mL fill are supplied in a 7.5 mL size bottle.
2.5 mL NDC 24208-457-25
5 mL NDC 24208-457-05

Store at 20°-25°C (68°-77°F). PROTECT FROM LIGHT.

Dispense in original, unopened container only.

Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

Revised: June 2016

9057306 (Folded)
9057206 (Flat)

Diclofenac is an anti-inflammatory drug. It comes in other forms, including oral tablets and capsules, powder packets, and transdermal gel, patch, and solution.

Talk to your doctor before taking diclofenac if you have heart disease or high blood pressure. It could make your condition worse.

Common side effects include stomach pain, nausea, and others.

• FDA warning See Details

• May cause increased blood pressure, puffiness, or water retention

• May affect some of your liver function tests See Details

• May cause allergic reaction See Details

• May cause some burning and stinging in your eyes See Details

What is diclofenac?

Diclofenac is a prescription drug. It is available in these forms: oral (capsules, tablets), eye drops, transdermal gel, transdermal patch, transdermal solution, and powder packets for oral solution.

Diclofenac is available in its generic form. Generic drugs usually cost less. In some cases they may not be available in every strength or form as the brand. Talk to your healthcare provider to see if the generic will work for you.

Why it's used

These drops help reduce swelling, which can happen after cataract surgery. 

How it works

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID).

More Details