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|Profenal Ophthalmic

ANTI-INFLAMMATORY DRUGS, NONSTEROIDAL (Ophthalmic)

Some commonly used brand names are:

In the U.S.—

• Ocufen ²
• Profenal ⁴
• Voltaren Ophthalmic ¹

In Canada—

• Indocid ³
• Ocufen ²
• Voltaren Ophtha ¹

Another commonly used name for indomethacin is indometacin .

Category

• Anti-inflammatory, nonsteroidal, ophthalmic—Diclofenac; Flurbiprofen; Indomethacin
• Miosis inhibitor, in ophthalmic surgery—Diclofenac; Flurbiprofen; Indomethacin; Suprofen
• Prostaglandin synthesis inhibitor, ophthalmic—Diclofenac; Flurbiprofen; Indomethacin; Suprofen

Description

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).

These medicines are available only with your doctor"s prescription, in the following dosage forms:

• Ophthalmic
• Diclofenac
  • Ophthalmic solution (U.S. and Canada)
• Flurbiprofen
  • Ophthalmic solution (U.S. and Canada)
• Indomethacin
  • Ophthalmic suspension (Canada)
• Suprofen
  • Ophthalmic solution (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ophthalmic anti-inflammatory medicines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to one of the ophthalmic anti-inflammatory medicines or other serious reactions, especially asthma or wheezing, runny nose, or hives, to any of the following medicines:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

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.

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.

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. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of these medicines. 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 of these medicines 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.

• For diclofenac
• Adults:
  • To treat photophobia (sensitivity to light) which may occur after incisional refractive surgery: 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.
  • To relieve inflammation in the eye following cataract surgery: 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 flurbiprofen
• Adults:
  • For use before an eye operation: Your health care professional will probably give you the medicine before your operation.
  • To relieve inflammation: Use and dose must be determined by the doctor.
• Children: Use and dose must be determined by the doctor.

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

• For suprofen
• Adults:
  • For use before an eye operation: 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, apply it as soon as possible. But if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

Other side effects may occur that usually do not need medical attention. The following side effects usually do not need medical attention. However, check with your doctor if they continue or are bothersome.

Less common or rare

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

Revised: 09/10/1998

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