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USP DI Vol. II - CORTICOSTEROIDS (Ophthalmic)

CORTICOSTEROIDS (Ophthalmic)


Some commonly used brand names are:

In the U.S.?

  • AK-Dex 2
  • AK-Pred 6
  • AK-Tate 6
  • Baldex 2
  • Decadron 2
  • Dexair 2
  • Dexotic 2
  • Econopred 6
  • Econopred Plus 6
  • Eflone 3
  • Flarex 3
  • Fluor-Op 3
  • FML Forte 3
  • FML Liquifilm 3
  • FML S.O.P. 3
  • HMS Liquifilm 5
  • Inflamase Forte 6
  • Inflamase Mild 6
  • I-Pred 6
  • Lite Pred 6
  • Maxidex 2
  • Ocu-Dex 2
  • Ocu-Pred 6
  • Ocu-Pred-A 6
  • Ocu-Pred Forte 6
  • Predair 6
  • Predair A 6
  • Predair Forte 6
  • Pred Forte 6
  • Pred Mild 6
  • Storz-Dexa 2
  • Ultra Pred 6

In Canada?

  • AK-Tate 6
  • Betnesol 1
  • Cortamed 4
  • Decadron 2
  • Diodex 2
  • Flarex 3
  • FML Forte 3
  • FML Liquifilm 3
  • HMS Liquifilm 5
  • Inflamase Forte 6
  • Inflamase Mild 6
  • Maxidex 2
  • Ophtho-Tate 6
  • PMS-Dexamethasone Sodium Phosphate 2
  • Pred Forte 6
  • Pred Mild 6
  • R.O.-Dexasone 2
  • Spersadex 2

Another commonly used name for hydrocortisone is cortisol.

Note:

For quick reference, the following corticosteroids are numbered tomatch the corresponding brand names.

This information applies to the following medicines:
1.Betamethasone (bay-ta-METH-a-sone)*
2.Dexamethasone (dex-a-METH-a-sone)?
3.Fluorometholone (flure-oh-METH-oh-lone)
4.Hydrocortisone (hye-droe-KOR-ti-sone)*
5.Medrysone (ME-dri-sone)
6.Prednisolone (pred-NISS-oh-lone)??
* Not commercially available in the U.S.
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

Category

  • Anti-inflammatory, steroidal, ophthalmic?Betamethasone; Dexamethasone; Fluorometholone; Hydrocortisone; Medrysone; Prednisolone
  • Corticosteroid, ophthalmic?Betamethasone; Dexamethasone; Fluorometholone; Hydrocortisone; Medrysone; Prednisolone

Description

Ophthalmic corticosteroids (kor-ti-ko-STER-oids) (cortisone-like medicines)are used to prevent permanent damage to the eye, which may occur with certaineye problems. They also provide relief from redness, irritation, and otherdiscomfort.

Corticosteroids for use in the eye are available only with your doctor'sprescription, in the following dosage forms:

    Ophthalmic
  • Betamethasone
    • Solution (eye drops) (Canada)
  • Dexamethasone
    • Ointment (U.S. and Canada)
    • Solution (eye drops) (U.S. and Canada)
    • Suspension (eye drops) (U.S. and Canada)
  • Fluorometholone
    • Ointment (U.S.)
    • Suspension (eye drops) (U.S. and Canada)
  • Hydrocortisone
    • Ointment (Canada)
  • Medrysone
    • Suspension (eye drops) (U.S. and Canada)
  • Prednisolone
    • Solution (eye drops) (U.S. and Canada)
    • Suspension (eye drops) (U.S. and Canada)


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 corticosteroids,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to corticosteroids. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Although studies on birth defects with ophthalmiccorticosteroids have not been done in humans, these medicines have not beenreported to cause birth defects or other problems. However, in animal studies,dexamethasone, fluorometholone, hydrocortisone, and prednisolone caused birthdefects when applied to the eyes of pregnant animals. Also, fluorometholoneand medrysone caused other unwanted effects in the animal fetus.

Breast-feeding?Ophthalmic corticosteroids have not been reportedto cause problems in nursing babies.

Children?Children less than 2 years of age may be especiallysensitive to the effects of ophthalmic corticosteroids. This may increasethe chance of side effects. If this medicine has been ordered for a youngchild, you should discuss its use with your child's doctor. Be sure you followall of the doctor's instructions very carefully.

Older adults?Although there is no specific information about theuse of ophthalmic corticosteroids in the elderly, they are not expected tocause different side effects or problems in older people than they do in youngeradults.

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]) ophthalmic medicine.

Other medical problems?The presence of other medicalproblems may affect the use of ophthalmic corticosteroids. Make sure you tellyour doctor if you have any other medical problems, especially:

  • Cataracts?Corticosteroids may cause cataracts or make themworse
  • Type 2 diabetes mellitus?Patients with diabetesmay be more likely to develop cataracts or glaucoma with the use of corticosteroids
  • Glaucoma (or family history of)?Corticosteroids may cause glaucomaor make it worse
  • Herpes infection of the eye or
  • Tuberculosis of the eye (active or history of) or
  • Any other eye infection?Ophthalmic corticosteroids may makeexisting infections worse or cause new infections

Proper Use of This Medicine

For patientswho wear contact lenses:

  • Use of ophthalmic corticosteroids while you are wearing contact lenses(either hard lenses or soft lenses) may increase the chance of infection.Therefore, do not apply this medicine while you are wearing contact lenses.Also, check with an ophthalmologist (eye doctor) for advice on how long towait after applying this medicine before inserting your contact lenses. Itis possible that you may be directed not to wear contact lenses at all duringthe entire time of treatment and for a day or two after treatment has beenstopped.

For patients using an ophthalmic solution or suspension (eye drop) form of this medicine:

  • If you are using a suspension form of this medicine, always shakethe container very well just before applying the eye drops.
  • 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.
    • If you think you did not get the drop of medicine into your eye properly,use another drop.
    • 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 dropperor the applicator tip to any surface (including the eye). Always keep thecontainer tightly closed.

For patients using an ointment form of thismedicine:

  • 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. Squeeze a thin strip of ointment into this space.A 1-cm (approximately 1/3 inch) strip of ointment is usually enough,unless you have been told by your doctor to use a different amount. Let goof the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutesto allow the medicine to come into contact with the irritation.
    • To keep the medicine as germ-free as possible, do not touch the applicatortip to any surface (including the eye). After using the eye ointment, wipethe tip of the ointment tube with a clean tissue. Do not wash the tip withwater. Always keep the tube tightly closed.

Do not use corticosteroids more often or for a longertime than your doctor ordered. To do so may increase the chance ofside effects, especially in children 2 years of age or younger.

Do not use any leftover medicine for future eye problemswithout first checking with your doctor. This medicine should not beused if certain kinds of infections are present. To do so may make the infectionworse and possibly lead to eye damage.

Dosing?The dose of ophthalmic corticosteroids willbe different for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of ophthalmic corticosteroids. If your dose is different, do not change it unless your doctor tellsyou to do so.

    For betamethasone
  • For eye disorders:
    • For ophthalmic solution (eye drops) dosageform:
      • Adults and children?Use one or two drops in the eye every oneor two hours, then space the doses further apart as the eye gets better.
    For dexamethasone
  • For eye disorders:
    • For ophthalmic ointment dosage form:
      • Adults and children?Use the ointment in the eye three or fourtimes a day, then space the doses further apart as the eye gets better.
    • For ophthalmic solution (eye drops) dosageform:
      • Adults and children?Use one or two drops in the eye up to sixtimes a day.
    • For ophthalmic suspension (eye drops)dosage form:
      • Adults and children?Use one or two drops in the eye four tosix times a day.
    For fluorometholone
  • For eye disorders:
    • For ophthalmic ointment dosage form:
      • Adults and children?Use the ointment in the eye one to threetimes a day.
    • For ophthalmic suspension (eye drops)dosage form:
      • Adults and children?Use one or two drops in the eye two tofour times a day.
    For hydrocortisone
  • For eye disorders:
    • For ophthalmic ointment dosage form:
      • Adults and children?Use the ointment in the eye three or fourtimes a day, then space the doses further apart as the eye gets better.
    For medrysone
  • For eye disorders:
    • For ophthalmic suspension (eye drops)dosage form:
      • Adults and children?Use one drop in the eye up to every fourhours.
    For prednisolone
  • For eye disorders:
    • For ophthalmic solution (eye drops) dosageform:
      • Adults and children?Use one or two drops in the eye up to sixtimes a day.
    • For ophthalmic suspension (eye drops)dosage form:
      • Adults and children?Use one or two drops in the eye two tofour times a day.

Missed dose?If you miss a dose of this medicine, apply 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 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 youwill be using this medicine for more than a few weeks, an ophthalmologist(eye doctor) should examine your eyes at regular visits to make sure it doesnot cause unwanted effects.

If your eye condition does not improve after 5 to 7 days, or if it becomesworse, check with your doctor.


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 as soon as possible if any of the following sideeffects occur:

    Less common or rare

      Decreased vision; eye infection; eye pain; gradual blurring or loss ofvision; nausea; vomiting

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

    More frequent

      Blurred vision (mild and temporary, occurs after use of ointments)

    Less common or rare

      Burning, stinging, redness, or watering of the eyes

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


Revised: 08/12/1998