Diclofenac Ophthalmic

Unless your doctor tells you otherwise, continue your normal diet.

If someone swallows diclofenac eye drops, call your local poison control center at 1-800-222-1222. Give the victim plenty of liquids to drink. If the victim has collapsed or is not breathing, call local emergency services at 911.

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

Diclofenac ophthalmic (for the eye) is used to reduce swelling, pain, and light sensitivity after cataract surgery or corneal refractive surgery.

Diclofenac ophthalmic may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze) or other NSAIDs.

Before using diclofenac ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder, diabetes, arthritis, glaucoma, dry eye syndrome, or if you have had other recent eye surgeries.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin, Jantoven).

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

For at least 3 days after your surgery, do not wear any contact lens that has not been approved by your doctor. Do not use any other eye medications unless your doctor has prescribed them.

You should not use this medication if you are allergic to diclofenac or other NSAIDs.

To make sure you can safely use diclofenac ophthalmic, tell your doctor if you have any of these other conditions:

• a bleeding or blood-clotting disorder;
• diabetes;
• arthritis;
• glaucoma;
• dry eye syndrome; or
• if you have had other recent eye surgeries.

FDA pregnancy category C. It is not known whether diclofenac ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether diclofenac ophthalmic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using diclofenac ophthalmic.

Contraindications

Hypersensitivity to ASA, NSAIDs, or components of the formulation

Cautions

Contains sodium sulfite which may cause allergic reactions in susceptible individuals NSAIDs may slow or delay healing

Potential for cross-sensitivity to other NSAIDs or aspirin

Interferes with platelet aggregation and may increase bleeding of ocular tissues; use caution in patients with predisposition to bleeding

Corneal effects, including keratitis, reported

Remove contact lenses before application, may reinsert 10 minutes after instilling drops

Corneal adverse reactions may occur in patients with keratitis after continued use that may result in loss of vision; discontinue use in patients with evidence of corneal epithelial damage

Use caution in patients with diabetes (may be at risk of corneal adverse effects that may result in loss of vision)

Use caution in patients with complicated ocular surgeries, corneal denervation, repeat ocular surface disease, or corneal epithelial defects

Use caution in patients with rheumatoid arthritis

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Nonsteroidal Anti-inflammatory Drug (NSAID)
• Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Concerns related to adverse effects:

• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid and phenylacetic acid derivatives, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy. The Canadian labeling contraindicates use in these patient populations.

• Bleeding and/or healing delay: May slow/delay healing or prolong bleeding time following surgery. Use caution in patients at risk of bleeding or taking concomitant medication that may increase risk of bleeding and in patients receiving concomitant topical steroid therapy due to risks for impaired/delayed healing and corneal complications.

• Keratitis: Use of topical ophthalmic NSAIDs may be associated with keratitis. Continued use may be associated with sight-threatening complications, including corneal perforation. Discontinue use of topical NSAIDs in any patient with evidence of corneal epithelial breakdown.

Disease-related concerns:

• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision. Onset or progression of ocular infections may be masked during therapy; monitor for development of infection and if necessary, initiate concurrent antimicrobial therapy.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Special populations:

• Post-surgical patients: To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Other warning/precautions:

• Follow up/monitoring: Monitor patients for 1 year following application of ophthalmic drops for corneal refractive procedures. Patients using diclofenac ophthalmic drops should not wear soft contact lenses.

• Prolonged use: Use of topical ophthalmic NSAIDs for more than 24 hours prior to surgery and greater than 14 days after ocular surgery has been associated with an increased risk of more frequent and severe corneal adverse events.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe burning, stinging, or itching of your eyes;

• eye pain, redness, or excessive watering;

• vision changes, increased sensitivity to light;

• white patches on your eyes;

• crusting or drainage of your eyes; or

• dizziness, stomach pain, vomiting, weakness, fever, chills, or flu symptoms (can occur if the medicine is absorbed into your bloodstream).

Less serious side effects may include:

• mild burning, stinging, or itching of your eyes;

• swollen or puffy eyelids;

• nausea, vomiting, stomach pain;

• weakness, fever or chills;

• headache;

• sleep problems (insomnia); or

• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.

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 according to the product package instructions for your brand, or ask your pharmacist. Do not store in the bathroom. Keep the bottle tightly closed when not in use. 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 2016. Copyright(c) 2016 First Databank, Inc.

1 drop in the affected eye, 4 times per day beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the post-operative period

Use: Treatment of post-operative inflammation in patients who have undergone cataract extraction

Administration advice:
-This drug is for instillation into the conjunctival sac only. It should not be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Patient advice:
-To prevent the active substances from being washed out when additional ophthalmic drug is used, an interval of at least 5 minutes between each application should be followed.
-Nasolacrimal occlusion or closing the eyes for 3 minutes may reduce the systemic absorption, which may result in a decrease in systemic side effects and an increase in local activity.
-Patients with blurred vision or other visual disturbances should avoid driving a vehicle or operating machines until vision improves.

Animal studies have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (premature closure of ductus arteriosus), the use of this drug during late pregnancy should be avoided.