Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1% solution is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C₁₄H₁₀C_l2NO₂Na. The structural formula of diclofenac sodium is:

Voltaren Ophthalmic is available as a sterile solution which contains diclofenac sodium 0.1% (1mg/mL).

Inactive Ingredients: polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water.

Diclofenac sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Voltaren Ophthalmic 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Voltaren Ophthalmic solution has a faint characteristic odor of castor oil.

Last updated on RxList: 10/3/2007

Voltaren Ophthalmic is indicated for the 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.

Cataract Surgery: One drop of Voltaren 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 post operative period.

Corneal Refractive Surgery: One or two drops of Voltaren 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.

Voltaren Ophthalmic 0.1% (1 mg/mL) Sterile Solution is supplied in a low density polyethylene (LDPE) white bottle with a LDPE Dropper Tip and Polypropylene grey closure. The 2.5 mL fill is supplied in a 7.5 mL size bottle. The 5.0 mL fill is supplied in a 10.0 mL size bottle.

Bottles of 2.5 mL NDC 58768-100-02

Bottles of 5 mL NDC 58768-100-05

Store at 15°C to 25°C (59° to 77°F). Dispense in original, unopened container only.

Made in Canada. Manufactured for: Novartis Ophthalmics, Duluth, Georgia 30097. September, 2003. FDA Rev date: 9/4/2007

Last updated on RxList: 10/3/2007

Clinical Practice: The following events 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 events, 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, epithelial breakdown, and superficial punctate keratitis, (see PRECAUTIONS, General).

Ocular: Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Voltaren Ophthalmic. In cataract surgery studies, keratitis was reported in up to 28% of patients receiving Voltaren Ophthalmic, 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 5% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, injection, iritis, irritation, itching, lacrimation disorder and ocular allergy.

Systemic: 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.

No information provided.

Last updated on RxList: 10/3/2007

The refractive stability of patients undergoing corneal refractive procedures and treated with Voltaren has not been established. Patients should be monitored for a year following use in this setting.

With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

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 Voltaren 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.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in rats given Voltaren 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 Voltaren up to 2 mg/kg/day did not reveal any oncogenic potential. Voltaren did not show mutagenic potential in various mutagenicity studies including the Ames test. Voltaren 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 Voltaren 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. Voltaren 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 Voltaren Ophthalmic during late pregnancy should be avoided.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last updated on RxList: 10/3/2007

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

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

Last updated on RxList: 10/3/2007

Pharmacodynamics

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.

Animal Studies

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.

Pharmacokinetics

Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of Voltaren Ophthalmic 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 Voltaren Ophthalmic.

Clinical Trials

Postoperative Anti-Inflammatory Effects

In two double-masked, controlled, efficacy studies of postoperative inflammation, a total of 206 cataract patients were treated with Voltaren Ophthalmic and 103 patients were treated with vehicle placebo. Voltaren Ophthalmic 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 Voltaren Ophthalmic and/or vehicle placebo. The efficacy of Voltaren Ophthalmic 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 Voltaren Ophthalmic for up to three days after PRK.

Last updated on RxList: 10/3/2007

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

Last updated on RxList: 10/3/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

DICLOFENAC - OPHTHALMIC

(dye-KLO-fen-ack)

COMMON BRAND NAME(S): Voltaren

USES: This medication is used to treat swelling (inflammation) and pain in the eye after certain types of eye surgery (cataract and corneal refractive surgery). Diclofenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release and effects of certain natural substances (prostaglandins) that cause pain and inflammation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat other eye conditions.

HOW TO USE: For cataract surgery, 1 drop is usually placed into the eye 4 times daily, starting 24 hours after surgery and continuing for 2 weeks after surgery, or as directed by your doctor.

For corneal refractive surgery, 1 or 2 drops are usually placed into the eye less than 1 hour before surgery. Less than 15 minutes after surgery, 1 or 2 drops are placed into the eye. This dose is repeated 4 times a day, up to 3 days after surgery or as directed by your doctor.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

This medication should not be used while wearing contact lenses. Consult your doctor or pharmacist for details.

If you are wearing contact lenses, remove them before using eye drops. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed.

Do not apply this medication more often than prescribed or continue using it for longer than directed by your doctor. Prolonged use of diclofenac eye drops may increase the risk of very serious side effects of the eye.

SIDE EFFECTS: Temporary irritation/burning/stinging of the eye, temporary blurred vision, or watery eyes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe pain/redness in the eye, sensitivity of the eyes to light (photophobia), eye discharge, blurry/abnormal vision, feeling as if something is in the eye, eyelid swelling, itching/redness/pain around the eyes, puffy face, headache, dizziness, trouble sleeping, vomiting, abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., naproxen, celecoxib); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, other eye problems (e.g., dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, asthma, growths in the nose (nasal polyps).

Vision may be temporarily blurred or unstable after applying eye drops. Use caution while driving, using machinery, or doing any activity that requires clear vision.

During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-platelet medications (e.g., clopidogrel), other NSAID medications (e.g., aspirin, ibuprofen), blood thinners (e.g., warfarin, heparin), other eye medications.

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from heat and light. Discard this medication if turns brown or cloudy or contains particles. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.