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USP DI Vol. II - ANTI-INFLAMMATORYDRUGS, NONSTEROIDAL (Ophthalmic)

ANTI-INFLAMMATORYDRUGS, 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.

Note:

For quick reference, the following nonsteroidal anti-inflammatorydrugs are numbered to match the corresponding brand names.

This information applies to the following medicines:
1.Diclofenac (dye-KLOE-fen-ak)
2.Flurbiprofen (flure-BI-proe-fen)?
3.Indomethacin (in-doe-METH-a-sin)*
4.Suprofen (soo-PROE-fen)?
* Not commercially available in the U.S.
? Not commercially available in Canada
? Generic name product may be available in the U.S.

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 tolessen problems that can occur during or after some kinds of eye surgery.Sometimes, the pupil of the eye gets smaller during an operation. This makesit more difficult for the surgeon to reach some areas of the eye. Some ofthese medicines are used to help prevent this. Also, some of them are usedafter eye surgery, to relieve effects such as inflammation or edema (too muchfluid in the eye).

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

These medicines are available only with your doctor's prescription, inthe 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 willdo. This is a decision you and your doctor will make. For ophthalmic anti-inflammatorymedicines, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to one of the ophthalmic anti-inflammatory medicines orother 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 othersubstances, such as foods, preservatives, or dyes.

Pregnancy?Although studies on birth defects have not been donein pregnant women after use of these medicines in the eye, ophthalmic anti-inflammatorymedicines have not been reported to cause birth defects or other problems.Studies have been done in animals receiving anti-inflammatory medicines bymouth in amounts that are much greater than the amounts used in the eye. Thesemedicines did not cause birth defects in these studies. However, they decreasedthe 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 largeenough to cause harmful effects in the mother. Also, when these medicineswere given to animals late in pregnancy, they increased the length of pregnancyor prolonged labor.

Breast-feeding?It is not known whether any of these medicinespass 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. Itis not known whether flurbiprofen passes into the breast milk when it is takenby mouth. However, these medicines have not been shown to cause problems innursing 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 beenshown to cause different side effects or problems in older people than theydo in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of these medicines. Make sure you tell your doctorif you have any other medical problems, especially:

  • Hemophilia or other bleeding problems?The possibility of bleedingmay be increased
  • Viral eye infection (epithelial herpes simplex keratitis), or a historyof having a viral eye infection?It is possible that a current infectioncould be made worse or an old infection could return
  • Use of soft contact lenses?Eye irritation, such as rednessand burning of the eyes, may occur

Proper Use of This Medicine

To use:

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

Do not use this medicine more often or for a longertime than your doctor ordered. To do so may increase the chance ofside effects.

Do not use any leftover medicine for future eye problemswithout first checking with your doctor. If certain kinds of infectionare present, using this medicine may make the infection worse and possiblylead to eye damage.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.

    For diclofenac
  • Adults:
    • To treat photophobia (sensitivity to light) which may occur afterincisional refractive surgery: Your health care professional will probablygive you the medicine before the operation, starting with 1 drop in the eyewithin one hour of surgery, then 1 drop fifteen minutes after surgery, then1 drop four times a day beginning four to six hours after surgery and continuingfor up to three days as needed.
    • To relieve inflammation in the eye following cataract surgery: 1drop in the eye four times a day beginning twenty-four hours after cataractsurgery 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 willprobably 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 willprobably give you the medicine before your operation.
    • To relieve inflammation or edema in the eye: 1 drop in the eye fourtimes 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 willprobably 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 assoon as possible. But if it is almost time for your next dose, skip the misseddose 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 surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Wearingsoft (hydrogel) contact lenses during treatment with diclofenac has causedsevere irritation (redness and itching) in some people. Therefore, do not wear soft contact lenses during the time that you arebeing 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 effectsoccur:

    Less common or rare

      Bleeding in the eye or redness or swelling of the eye or theeyelid (not present before you started using this medicine or becoming worsewhile you are using this medicine); blurred visionor 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

Other sideeffects may occur that usually do not need medical attention. The followingside effects usually do not need medical attention. However, check with yourdoctor if they continue or are bothersome.

    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 above may also occur insome patients. If you notice any other effects, check with your doctor.


Revised: 09/10/1998