menu 1 menu 2 menu 3 menu 4 menu 5 menu 6
home sitemap advanced search
USP DI Vol. II - BROMFENAC (Ophthalmic)

BROMFENAC (Ophthalmic)?


Some commonly used brand names are:

In the U.S.?

  • Xibrom

? Not commercially available in Canada.


Category

  • Anti-inflammatory,nonsteroidal (ophthalmic)

Description

Bromfenac (BROME-fen-ak)is a drug used to treat inflammation of the eye following cataract surgery.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

    Ophthalmic
  • Ophthalmic solution (eye drops) (U.S.)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual or allergicreaction to bromfenac. Also tell your health care professional if you areallergic to any other substances, such as foods, preservatives or dyes.

Pregnancy?Ophthalmic bromfenac has not been studied in pregnantwomen. However, studies in animals have shown that bromfenac causes embryo-fetallethality, increased neonatal mortality, and reduced postnatal growth in ratsand post-implantation loss in rabbits. Before taking this medicine, make sureyour doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether ophthalmic bromfenacpasses into breast milk. Although most medicines pass into breast milk insmall amounts, many of them may be used safely while breast-feeding. Motherswho are taking this medicine and who wish to breast-feed should discuss thiswith their doctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of ophthalmicbromfenac in children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of ophthalmic bromfenac in the elderly with use in other agegroups, this medicine has been used mostly in elderly patients and is notexpected to cause different side effects or problems than it does in youngeradults.

Other medical problems?The presence of other medical problems mayaffect the use of bromfenac. Make sure you tell your doctor if you have anyother medical problems, especially:

  • Bleeding problems of the eye?May be worsened by bromfenac
  • Corneal denervation or
  • Corneal epithelial defects or
  • Diabetes mellitus or
  • Ocular surface diseases (e.g., dry eyes) or
  • Ocular surgeries, complicated or
  • Ocular surgeries, multiple within a short period of time or
  • Rheumatoid arthritis?May increase the risk of experiencingcorneal problems
  • Allergy to sulfites?May cause allergic-type reactions

Proper Use of This Medicine

To use:

  • The bottle is only partially full to provide proper drop control.
  • First, wash your hands. Tilt the head back and, pressing your fingergently on the skin just beneath the lower eyelid away from the eye to makea space. Drop the medicine into this space. Let go of the eyelid and gentlyclose the eyes. Do not blink. Keep the eyes closed and apply pressure to theinner corner of the eye with your finger for 1 or 2 minutes to allow the medicineto 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 applicator tip to any surface (including the eye).Also, keep the container tightly closed. Serious damage to the eye and possibleloss of vision may result from using contaminated eye drops.

Dosing?The dose of ophthalmic bromfenac will bedifferent for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of ophthalmic bromfenac. If yourdose is different, do not change it unless your doctor tells you todo so.

The number of eye drops that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking bromfenac

  • For ophthalmic dosage form (solution):
    • For eye inflammation following cataract surgery:
      • Adults?1 drop to the problem eye 2 times a day; treatment shouldstart 24 hours after surgery and continue for 2 weeks
      • Children?Use and dose must be determined by your doctor.

Missed dose? If you miss a dose of this medicine, apply itas soon as possible. Then, go back to your regular dosing schedule.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store at room temperature.

Precautions While Using This Medicine

Ifyour symptoms do not improve within a few days or if they become worse, checkwith your doctor.

While applying the medicine, your eyes will probably sting or burn fora short time. This is to be expected.


Side Effects of This Medicine

    Alongwith its needed effects, a medicine may cause some unwanted effects. Althoughnot all of these side effects may occur, if they do occur they may need medicalattention.

      Incidence not determined?observed during clinical practice, estimates of frequencycan not be determined

        Vision changes

    Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. Also, your health care professionalmay be able to tell you about ways to prevent or reduce some of these sideeffects. Check with your health care professional if any of the followingside effects continue or are bothersome or if you have any questions aboutthem:

      More common

        Abnormal sensation in eye; burning orstinging of the eye; eye irritation; eye pain; eye redness; headache; increase in blood flow tothe whites of the eyes; itching of the eyes; sensitivity to light; tearing; throbbing pain

      Incidence not determined?observed during clinical practice, estimates of frequencycan not be determined

        Blurred vision orother changes in vision


Developed: 06/13/2005