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USP DI Vol. II - OFLOXACIN (Ophthalmic)

OFLOXACIN (Ophthalmic)


Some commonly used brand names are:

In the U.S.?

  • Ocuflox

In Canada?

  • Ocuflox

Category

  • Antibacterial, ophthalmic

Description

Ofloxacin (oh-FLOKS-a-sin) is an antibiotic usedto treat bacterial infections of the eye, such as conjunctivitis and cornealulcers.

Ofloxacin is available only with your doctor's prescription, in the followingdosage form:

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


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 ofloxacin,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to ophthalmic or systemic ofloxacin (e.g., Floxin) or anyrelated medicines, such as cinoxacin (e.g., Cinobac), ciprofloxacin (e.g.,Ciloxan or Cipro), enoxacin (e.g., Penetrax), lomefloxacin (e.g., Maxaquin),nalidixic acid (e.g., NegGram), or norfloxacin (e.g., Chibroxin or Noroxin).Also tell your health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Ophthalmic ofloxacin has not been studied in pregnantwomen. However, studies in animals that were given very high doses of ofloxacinby mouth have shown that ofloxacin can cause birth defects or other problems.Before taking this medicine, make sure your doctor knows if you are pregnantor if you may become pregnant.

Breast-feeding?It is not known whether ophthalmic ofloxacin passesinto breast milk. However, ofloxacin given by mouth does pass into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who are using thismedicine and who wish to breast-feed should discuss this with their doctor.

Children?Use is not recommended in infants up to 1 year ofage. In children 1 year of age and older, this medicine is not expected tocause different side effects or problems than it does in adults.

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 or if they cause different side effectsor problems in older people. There is no specific information comparing useof ophthalmic ofloxacin in the elderly with use in other age groups.

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 that is to be used in the eye.


Proper Use of This Medicine

To use:

  • First, wash your hands. Tilt the head back and with the index fingerof one hand, press gently on the skin just beneath the lower eyelid and pullthe lower eyelid away from the eye to make a space. Drop the medicine intothis space. Let go of the eyelid and gently close the eyes. Do not blink.Keep the eyes closed for 1 to 2 minutes, to allow the medicine to come intocontact with the infection.
  • If you think you did not get the drop of medicine into your eyesproperly, use another drop.
  • To keep the medicine as germ-free as possible, do not touch the applicatortip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keepusing ophthalmic ofloxacin for the full time of treatment, even ifyour symptoms have disappeared. Do not miss any doses.

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

  • For ophthalmic (eye drops) dosage form:
    • For conjunctivitis:
      • Adults and children 1 year of age and older?Use 1 drop in theaffected eye every two to four hours, while you are awake, for two days. Then,use 1 drop in each eye four times a day for up to five more days.
      • Infants up to 1 year of age?Use and dose must be determinedby your doctor.
    • For bacterial corneal ulcers:
      • Adults and children 1 year of age and older?Use 1 drop in theaffected eye every thirty minutes while you are awake and 1 drop four to sixhours after you go to bed, for two days. Then use 1 drop every hour whileyou are awake for up to seven more days. After the seventh, eighth, or ninthday, as instructed by your doctor, use 1 drop four times a day until yourdoctor determines that the treatment is complete.
      • Infants up to 1 year of age?Use and dose must be determinedby your doctor.

Missed dose?If you miss a dose of this medicine, use it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 refrigerate.
  • 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

If youreye infection does not improve within 7 days, or if it becomes worse, checkwith your doctor.

Discontinue using these eye drops immediately and contactyour physician at the first sign of a rash or an allergic reaction.

This medicine may cause your eyes to become more sensitive to light thanthey are normally. Wearing sunglasses and avoiding too much exposure to brightlight may help lessen the discomfort.


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 mayneed medical attention.

Check with your doctor immediately if any ofthe following side effects occur:

    Rare

      Puffiness or swelling of eyes; signsof an allergic reaction, such as hives, itching, rash, swelling of face orlips, tightness in chest, troubled breathing, or wheezing

Check with your doctor as soon as possible if the following side effectoccurs:

    Rare

      Dizziness

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

    More common

      Burning of eye

    Less common

      Blurred vision; eye pain; feeling of something in the eye; increasedsensitivity of eye to light; redness, irritation,or itching of eye, eyelid, or inner lining of eyelid; stinging, tearing, or dryness of eye

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


Revised: 09/22/1998