Voltaren Ophthalmic

Dosing Strength

ophthalmic solution

• 0.1%

Cataract Surgery

1 gtt in affected eye(s) four times daily for 2 weeks, beginning 24 hours post-surgery

Corneal Refractive Surgery

1-2 gtt in affected eye(s) within 1 hour pre-op & 15 minutes post-op; continue 1-2 gtt four times daily for 3 days

Safety & efficacy not established

Frequency Not Defined

Mild ocular stinging, irritation

May slow corneal wound healing

Lacrimation

Increased IOP

Keratitis

Dizziness

Insomnia

Pain

Fever

Chills

Nausea/vomiting

Abdominal pain

Corneal deposits

Corneal edema

Conjunctivitis

Irritation

Eyelid swelling

Corneal perforation

Corneal thinning

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Diclofenac ophthalmic is usually given 24 hours before cataract surgery, and continued for 3 to 14 days after surgery. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

Wash your hands before using eye medication.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

• Use the eye drops only in the eye you are having surgery on.

• Use only the number of drops your doctor has prescribed.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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 10% or less of 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.

Systemic

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

Clinical Practice

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 epithelial breakdown, (see PRECAUTIONS, General).

NDC 0078-0478-61

Voltaren
OPHTHALMIC®
(diclofenac
sodium
ophthalmic
solution)
0.1%

5 mL       Alcon®

This medication is used to treat swelling (inflammation) of the eye after cataract surgery. It is also used after another type of eye surgery (corneal refractive surgery) to temporarily relieve pain and sensitivity of the eye to light. Diclofenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs).

How to use Voltaren Drops

Apply this medication to the affected eye as directed by your doctor. The dosage and duration of treatment is based on your medical condition and response to treatment.

Do not wear contact lenses while you are using this medicine unless your doctor approves of it. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.

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.

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 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 the single dose units, discard the unit and any remaining solution after one use.

If you are using another kind of eye medication (for example, other 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.

This medication is intended for short-term use only. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of serious side effects.

Do not use this product if it becomes contaminated (for example, drops turn cloudy or a dark color). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.

Tell your doctor if your symptoms persist or if they worsen.

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes, rheumatoid arthritis.

Your vision may be temporarily blurred after applying this medication. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

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

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: corticosteroids (such as prednisone).

This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.