Brand Names:

• Acular
• Acular LS
• Acular PF
• Acuvail
• Bromday
• Bromsite
• Ilevro
• Nevanac
• Ocufen
• Prolensa
• Voltaren
• Xibrom
• Apo-Ketorolac
• Ratio-Ketorolac
• Vofenal
• Voltaren Ophtha

Dosage Forms:

• Solution
• Suspension

Uses of This Medicine:

Ophthalmic anti-inflammatory medicines are used in the eye to lessen problems that can occur during or after some kinds of eye surgery. Sometimes, the pupil of the eye gets smaller during an operation. This makes it more difficult for the surgeon to reach some areas of the eye. Some of these medicines are used to help prevent this. Also, some of them are used after eye surgery, to relieve effects such as inflammation or edema (too much fluid in the eye).

These medicines may also be used for other conditions, as determined by your ophthalmologist (eye doctor).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

These medicines have been studied only in adults, and there is no specific information about their use in children.

Older adults—

These medicines have been tested and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy—

Although studies on birth defects have not been done in pregnant women after use of these medicines in the eye, ophthalmic anti-inflammatory medicines have not been reported to cause birth defects or other problems. Studies have been done in animals receiving anti-inflammatory medicines by mouth in amounts that are much greater than the amounts used in the eye. These medicines did not cause birth defects in these studies. However, they decreased the weight or slowed the growth of the fetus and caused other, more serious, harmful effects on the fetus when they were given in amounts that were large enough to cause harmful effects in the mother. Also, when these medicines were given to animals late in pregnancy, they increased the length of pregnancy or prolonged labor.

Breast-feeding—

It is not known whether any of these medicines pass into the breast milk after they are placed in the eye. Diclofenac, indomethacin, and suprofen pass into the breast milk when they are are taken by mouth. It is not known whether flurbiprofen passes into the breast milk when it is taken by mouth. However, these medicines have not been shown to cause problems in nursing babies.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentoxifylline
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Bivalirudin
• Budesonide
• Cangrelor
• Certoparin
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clopidogrel
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desirudin
• Desvenlafaxine
• Dexamethasone
• Dipyridamole
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Feverfew
• Fluoxetine
• Fluvoxamine
• Fondaparinux
• Ginkgo
• Heparin
• Hydrocortisone
• Iloprost
• Lepirudin
• Levomilnacipran
• Meadowsweet
• Melphalan
• Methotrexate
• Methylprednisolone
• Milnacipran
• Nadroparin
• Nefazodone
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Prasugrel
• Prednisolone
• Prednisone
• Protein C
• Reviparin
• Rivaroxaban
• Selexipag
• Sertraline
• Sibutramine
• Sulfinpyrazone
• Sulodexide
• Tenofovir Alafenamide
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Treprostinil
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Hemophilia or other bleeding problems—The possibility of bleeding may be increased.

• Viral eye infection (epithelial herpes simplex keratitis), or a history of having a viral eye infection—It is possible that a current infection could be made worse or an old infection could return.

• Use of soft contact lenses—Eye irritation, such as redness and burning of the eyes, may occur.

Proper Use of This Medicine:

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always keep the container tightly closed.

Do not use this medicine more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not use any leftover medicine for future eye problems without first checking with your doctor. If certain kinds of infection are present, using this medicine may make the infection worse and possibly lead to eye damage.

Dosing—

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• To treat photophobia (sensitivity to light) which may occur after incisional refractive surgery:
  • Adults—Your health care professional will probably give you the medicine before the operation, starting with 1 drop in the eye within one hour of surgery, then 1 drop fifteen minutes after surgery, then 1 drop four times a day beginning four to six hours after surgery and continuing for up to three days as needed.
  • Children—Use and dose must be determined by the doctor.
• To relieve inflammation in the eye following cataract surgery:
  • Adults—1 drop in the eye four times a day beginning twenty-four hours after cataract surgery and throughout the first two weeks following the operation.
  • Children—Use and dose must be determined by the doctor.

• For use before an eye operation:
  • Adults—Your health care professional will probably give you the medicine before your operation.
  • Children—Use and dose must be determined by the doctor.
• To relieve inflammation:
  • Adults and children—Use and dose must be determined by the doctor.

• For use before an eye operation:
  • Adults—Your health care professional will probably give you the medicine before your operation.
  • Children—Use and dose must be determined by the doctor.
• To relieve inflammation or edema in the eye:
  • Adults—1 drop in the eye four times a day.
  • Children—Use and dose must be determined by the doctor.

• For use before an eye operation:
  • Adults—Your health care professional will probably give you the medicine before your operation.
  • Children—Use and dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Wearing soft (hydrogel) contact lenses during treatment with diclofenac has caused severe irritation (redness and itching) in some people. Therefore, do not wear soft contact lenses during the time that you are being treated with diclofenac.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Bleeding in the eye or redness or swelling of the eye or the eyelid (not present before you started using this medicine or becoming worse while you are using this medicine)

blurred vision or other change in vision

fever or chills

itching or tearing

nausea or vomiting

pain

sensitivity to light

shortness of breath

sticky or matted eyelashes

swelling of face

throbbing pain

tightness in chest

troubled breathing

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, stinging, or mild discomfort after application

dry eyes

Less common or rare

Bigger or smaller pupils (black part of eye)

headache

trouble in sleeping

runny or stuffy nose

unusual weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.