Corticosteroids (Ophthalmic)

This monograph includes information on the following:

1) Betamethasone  *
2) Dexamethasone
3) Fluorometholone
4) Hydrocortisone  *
5) Medrysone
6) Prednisolone

VA CLASSIFICATION
Betamethasone
Primary: OP301

Dexamethasone
Primary: OP301

Fluorometholone
Primary: OP301

Hydrocortisone
Primary: OP301

Medrysone
Primary: OP301

Prednisolone
Primary: OP301


Commonly used brand name(s): AK-Dex2; AK-Pred6; AK-Tate6; Baldex2; Betnesol1; Cortamed4; Decadron2; Dexair2; Dexotic2; Diodex2; Econopred6; Econopred Plus6; Eflone3; FML Forte3; FML Liquifilm3; FML S.O.P3; Flarex3; Fluor-Op3; HMS Liquifilm5; I-Pred6; Inflamase Forte6; Inflamase Mild6; Lite Pred6; Maxidex2; Ocu-Dex2; Ocu-Pred6; Ocu-Pred Forte6; Ocu-Pred-A6; Ophtho-Tate6; PMS-Dexamethasone Sodium Phosphate2; Pred Forte6; Pred Mild6; Predair6; Predair A6; Predair Forte6; R.O.-Dexasone2; Spersadex2; Storz-Dexa2; Ultra Pred6.

Another commonly used name for hydrocortisone is
cortisol .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.



Category:


Corticosteroid (ophthalmic)—

anti-inflammatory (steroidal), ophthalmic—
Note: Ophthalmic dosage forms of betamethasone and hydrocortisone are not commercially available in the U.S.; therefore, there is no U.S. product labeling identifying approved indications.



Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Ophthalmic disorders (treatment)—Ophthalmic corticosteroids are indicated in the treatment of corticosteroid-responsive allergic and inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. {14} {16} {20} {22} {35} {37} {38} {39} {46} {47} {48} {49} {52} {53} {54} {65} {66} {67} {81} {113}
—Fluorometholone (0.1%), medrysone, or prednisolone (0.12 or 0.125%) may be preferred for long-term treatment because they are least likely to increase intraocular pressure. {06} {46} {48} {71} {79} {100} {101} {106}
—Very severe ocular disorders that do not respond to topical corticosteroid therapy may require treatment with systemic corticosteroids. In some cases, concurrent topical and systemic corticosteroid therapy may be utilized. {66}

Table 1. Indications *



Note: Bracketed information refers to uses that are not included in U.S. product labeling.
Ophthalmic dosage forms of betamethasone and hydrocortisone are not commercially available in the U.S.; therefore, there is no U.S. product labeling identifying approved indications.
Legend:
I=Betamethasone
II =Dexamethasone
III=Fluorometholone


IV=Hydrocortisone
V=Medrysone
VI=Prednisolone

I
 
II
 
III
 
IV
 
V
 
VI
 
Indicated in the treatment of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as:

Allergic disorders, ophthalmic (treatment) {102}




 
Anterior segment disease, inflammatory (treatment) {34}




 
Conjunctivitis, allergic (treatment) {34} {79} {81} {102} {107} {113}






Corneal injuries (treatment) {34} {81} {113}




 
Cyclitis (treatment) {34} {81}




 
Episcleritis (treatment) {79} {107}






Iridocyclitis (treatment) {34} {81} {113}




[ ]1
 

Keratitis, herpes zoster (treatment) {34} {81} {113}
 


[ ]1
 

Keratitis not associated with herpes simplex or fungal infection (treatment) {34}




[ ]1
 

Keratitis, punctate, superficial (treatment) {34} {79} {80} {81} {113}




[ ]1
 

Keratitis, vernal (treatment) {34}




[ ]1
 

Keratoconjunctivitis, allergic (treatment) {34} {102}




[ ]1
 

Keratoconjunctivitis, vernal (treatment) {34} {79} {107}






Ocular infections, superficial (treatment adjunct) {81} {113}




[ ]1
 

Ocular sensitivity to epinephrine (treatment) {79} {107}






Ophthalmia sympathetic (treatment)




[ ]1
 

Rosacea, ocular (treatment) {34} {81} {113}




[ ]1
 

* Indications for specific agents may vary because of lack of specific testing and/or clinical-use data. Although all of these medications are used for all of the listed indications, medrysone may be less effective than the other ophthalmic corticosteroids for any condition other than conjunctivitis.
 Use in the treatment of ocular infection requires that the risk of corticosteroid-induced exacerbation of existing infection or development of secondary infections be weighed against the need for reducing inflammation and edema. [Appropriate anti-infective therapy should also be administered as required.] {81}
1 Not commercially available in Canada.


Unaccepted
Topical corticosteroids for ophthalmic use are not indicated in the treatment of degenerative ocular disorders. {45} Also, if corticosteroid therapy is required for the treatment of disorders involving deep ocular structures, the medication should be administered systemically because topical application will not be effective.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
{69}    Betamethasone sodium phosphate: 516.41
    Dexamethasone: 392.47
    Dexamethasone sodium phosphate: 516.41
    Fluorometholone: 376.47
    Fluorometholone acetate: 418.51
    Hydrocortisone acetate: 404.50
    Medrysone: 344.49
    Prednisolone acetate: 402.49
    Prednisolone sodium phosphate: 484.39

Mechanism of action/Effect:

Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA, and stimulate transcription of mRNA and subsequent protein synthesis of enzymes ultimately responsible for anti-inflammatory effects of topical application of corticosteroids to the eye. {46} {106} In high concentrations, which may be achieved after topical application, corticosteroids may exert direct membrane effects {102}. Corticosteroids decrease cellular and fibrinous exudation and tissue infiltration, inhibit fibroblastic and collagen-forming activity, retard epithelial regeneration, diminish postinflammatory neovascularization, and reduce toward normal levels the excessive permeability of inflamed capillaries. {46} {48}

Absorption:

Absorbed into aqueous humor, cornea, iris, choroid, ciliary body, and retina. Systemic absorption occurs, but may be significant only at higher dosages or in extended pediatric therapy.


Precautions to Consider

Carcinogenicity/Mutagenicity

Dexamethasone—Long-term animal studies have not been conducted to evaluate the carcinogenicity of dexamethasone. {14} {15} {37}

Fluorometholone, medrysone, and prednisolone—Studies in animals or humans have not been conducted to evaluate the carcinogenic or mutagenic potential of fluorometholone, medrysone, and prednisolone. {13} {22} {23} {25} {46} {47} {48} {53} {54} {71}

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented; however, adequate and well-controlled studies with these agents have not been done. {16} {20} {35} {37} {38} {45} {52} {53} {54} {61} {65} {66} {67} {71}

Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Studies in rabbits have shown that corticosteroids produce fetal resorptions and multiple abnormalities, including those of the head, ears, limbs, and palate. {14} {15} {37}


Dexamethasone, hydrocortisone, and prednisolone

Studies in pregnant mice have shown that these medications, when applied to both eyes 5 times a day on Days 10–13 of gestation, caused a significant increase in fetal cleft palate. {01} {37} {53} {54} {66}

Dexamethasone and prednisolone—FDA Pregnancy Category C. {113}



Fluorometholone

Studies in pregnant rabbits have shown that fluorometholone is teratogenic and embryocidal when applied to the eyes at various dosage levels on Days 6–18 of gestation. {02} {22} {46} {47} {48} {67}

FDA Pregnancy Category C.



Medrysone

Studies in pregnant rabbits have indicated that medrysone (doses 10 and 30 times the human dose or higher) is embryocidal. {71} Also, application to the eyes (2 drops 4 times a day on Days 6–18 of gestation) of pregnant rabbits caused an increase in early resorptions. {71}

FDA Pregnancy Category C.


Breast-feeding

Problems in humans have not been documented. {46} {53} {54} {66} {67}

Pediatrics

Corticosteroids should be used with caution in children 2 years of age or younger because the different dose/weight ratio for children increases the risk of adrenal suppression. This risk increases with the length of therapy, which, therefore, should be limited to the shortest possible time (preferably less than 5 days). {46} {47} {48} {49} {94}


Geriatrics


Appropriate studies on the relationship of age to the effects of ophthalmic corticosteroids have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Antiglaucoma agents    (chronic or intensive use of ophthalmic corticosteroids may increase intraocular pressure and decrease the efficacy of antiglaucoma agents)


Anticholinergics, especially atropine and related compounds    (risk of intraocular hypertension may be increased with prolonged corticosteroid therapy {07}; may be more likely to occur during use of cycloplegic/mydriatic agents in patients predisposed to acute angle closure {94})


Contact lenses    (risk of infection increased {94} {104})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, these medications should not be used when the following medical problems exist:
» Fungal diseases, ocular, or{34}{79}{104}{113}
» Herpes simplex keratitis, acute superficial, or{34}{79}{103}{104}{105}{113}
» Tuberculosis, ocular, active or history of, or{34}{79}{104}{113}
» Viral disease, acute, infectious{34}{79}{104}{113}    (corticosteroids decrease human resistance to bacterial, fungal, and viral infections; application may exacerbate existing infections and encourage the development of new or secondary infections {14} {16} {20} {22} {34} {35} {37} {38} {39} {46} {47} {48} {49} {52} {53} {54} {60} {62} {65} {67} {71} {104})


Risk-benefit should be considered when the following medical problems exist
» Cataracts    (may be exacerbated)


Diabetes mellitus    (patient may be predisposed toward increases in intraocular pressure and/or cataract formation {06})


Diseases causing thinning of the cornea or sclera    (use may result in perforation {13} {14} {15} {16} {17} {18} {19} {20} {21} {22} {23} {24} {25} {26} {27} {28} {30} {31} {32} {33} {34} {35} {38} {39} {44} {46} {47} {53} {54} {62} {67} {96} {113})


» Glaucoma, chronic, open-angle, or family history of    (may be precipitated or exacerbated {34} {44} {52} {62} {67} {97} {113})


» Infections of the cornea or conjunctiva, other    (risk of exacerbation or development of secondary infections {20} {22} {34} {35} {44} {45} {46} {47} {48} {49} {52} {53} {54} {60} {62} {67} {71} {99} {104} {113})


Sensitivity to corticosteroids{14}{16}{22}{35}{37}{38}{39}{44}{45}{46}{47}{48}{49}{53}{54}{60}{62}{65}{67}{71}{113}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Ophthalmologic examinations, especially tonometry and slit-lamp examination    (initial ophthalmologic examinations should be performed 2 to 3 weeks following onset of chronic therapy; subsequent examinations are performed at intervals as determined by patient status or risk factors {14} {16} {20} {22} {34} {35} {37} {38} {39} {44} {46} {47} {48} {49} {52} {53} {54} {65} {67} {71} {104})




Side/Adverse Effects

Note: Frequent or intensive use of ophthalmic corticosteroids may retard corneal healing. {07} {22} {37} {45} {46} {47} {48} {102}
Systemic absorption occurs, but may be significant only at higher dosages or in extended pediatric therapy. The different dose/weight ratio for children increases the risk of adrenal suppression. {136}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare
    
Corneal thinning and/or globe perforation{14}{16}{20}{22}{34}{35}{37}{38}{39}{45}{46}{47}{48}{49}{52}{53}{54}{55}{56}{57}{58}{59}{60}{61}{62}{63}{64}{65}{66}{67}{71}{96} (decreased vision{135}; watering of the eyes{135})
    
glaucoma{97}{100}{103}{104}
ocular hypertension{34}{100}{101}{104}
optic nerve damage
posterior subcapsular cataract{34}{103}{104}
visual acuity and field defects{103}{104} (gradual blurring or loss of vision; eye pain; nausea; vomiting){14}{16}{20}{22}{35}{37}{38}{39}{45}{46}{47}{48}{49}{52}{54}{62}{65}{66}{67}{71}
    
secondary ocular infection{14}{16}{20}{22}{35}{37}{38}{39}{45}{46}{47}{48}{52}{53}{60}{62}{65}{66}{67}{98}{99}{103}{104}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Temporary mild blurred vision —may be expected to occur after use of ointments

Incidence less frequent or rare
    
Burning, stinging, redness, or watering of the eyes{14}{16}{34}{37}{38}{39}{45}{48}{60}{66}{67}{71}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Generally, acute oral overdose of ophthalmic corticosteroids does not result in serious adverse effects. {45} {48} Dilution with fluids is the mainstay of therapy. {45} {48} {53} {54} {71}


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Corticosteroids (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to corticosteroids





Use in children—Cautious and short-term use recommended

Other medical problems, especially eye infections (other), cataracts, or glaucoma

Proper use of this medication
For contact lens wearers: Checking with ophthalmologist prior to use; contact lenses should not be worn during, and possibly for a time following, application of these medications because of an increased risk of infection

Shaking suspensions vigorously before applying

Proper administration technique

Preventing contamination: Not touching applicator tip to any surface and keeping container tightly closed {36} {62} {65}

» Importance of not using more medication than the amount prescribed (especially in children)

» Checking with physician before using medication for future eye problems

» Proper dosing

Missed dose
Using as soon as possible; not using if almost time for next dose

» Proper storage

Precautions while using this medication
Need for ophthalmologic examinations during long-term therapy

Checking with physician if there is no improvement after 5 to 7 days of therapy or if condition worsens {62} {65}


Side/adverse effects
Signs of potential side effects, especially corneal thinning and/or globe perforation, glaucoma, ocular hypertension, optic nerve damage, posterior subcapsular cataract, visual acuity and field defects, or secondary ocular infection


General Dosing Information
The severity and location of ocular inflammation often requires dosage to be higher and/or more frequent than the usual adult dose initially, then gradually reduced to as little as necessary to maintain the therapeutic effect. If infections do not respond promptly, the ophthalmic corticosteroid should be discontinued until the infection has been controlled. {44}

Increasing the frequency of administration is usually as effective as, or more effective than, using higher concentrations of the medication.

The duration of treatment may vary from a few days to several weeks or months in some cases, depending on the condition being treated. Daily or alternate-day therapy may be indicated for extended periods in certain situations, such as following penetrating keratoplasty. {15} {37} {60} {66}

Although ophthalmic corticosteroids should not be used longer than is medically necessary, it is recommended that treatment be continued after apparent response, with the dosage gradually tapered to avoid relapse. {22} {37} {47}

At night, the ophthalmic ointment, where available, may be used as an adjunct to the ophthalmic solution or suspension to provide prolonged contact with the eye. {36} {60}

BETAMETHASONE


Ophthalmic Dosage Forms

BETAMETHASONE SODIUM PHOSPHATE OPHTHALMIC/OTIC SOLUTION

Note: The dosing and strengths of the dosage form available are expressed in terms of betamethasone base.


Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.1% (base) solution every one or two hours initially, with dosage gradually being decreased as inflammation subsides. {44} {84}


Usual pediatric dose
See Usual adult and adolescent dose .

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


0.1% (base) (Rx) [Betnesol{44}{84}{129}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.



DEXAMETHASONE


Ophthalmic Dosage Forms

DEXAMETHASONE OPHTHALMIC OINTMENT

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of a 0.1% ointment three or four times a day initially. {74} After a favorable response is obtained, the number of applications per day may be gradually reduced prior to discontinuation. {74}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


0.1% (Rx) [Maxidex{74}{112} (methylparaben) (propylparaben)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.



DEXAMETHASONE OPHTHALMIC SUSPENSION USP

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.1% suspension four to six times a day. {09} {20} {35} {74} {83}


Note: In severe conditions, treatment may be initiated with 1 or 2 drops every hour, with dosage gradually being decreased as inflammation subsides. {20} {35} {74} {83}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


0.1% (Rx) [Maxidex{35}{83}{115}][Generic]

Canada—


0.1% (Rx) [Maxidex{56}{74}{112} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For the eye.
   • Shake well. {83}

Note: Dispense in original unopened container.



DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC OINTMENT USP

Note: The dosing and strengths of the dosage form available are expressed in terms of dexamethasone phosphate not dexamethasone sodium phosphate.


Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of a 0.05% (phosphate) ointment three or four times a day initially. {16} {38} {39} {82} After a favorable response is obtained, the number of applications per day may be gradually reduced prior to discontinuation. {16} {18} {36} {37} {38} {39} {82}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.05% (phosphate) (Rx) [AK-Dex{16}{38}{114} (methylparaben, propylparaben)] [Baldex{39} (methylparaben) (propylparaben)] [Decadron{14}{37}{113}] [Dexair{18}{43}{82} (methylparaben) (propylparaben)] [Maxidex{19}{36}{115}] [Ocu-Dex][Generic]{10}{70}{132}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.



DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION USP

Note: The dosing and strengths of the dosage form available are expressed in terms of dexamethasone phosphate not dexamethasone sodium phosphate.


Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.1% (phosphate) solution up to six times a day. {15} {38} {39} {45} {81}


Note: In severe conditions, treatment may be initiated with 1 or 2 drops every hour, with dosage gradually being decreased as inflammation subsides. {15} {38} {39} {45} {81}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.1% (phosphate) (Rx) [AK-Dex{38}{114} (benzalkonium chloride)] [Baldex{39} (sodium bisulfite) (benzalkonium chloride)] [Decadron{15} (sodium bisulfite 0.1%) (benzalkonium chloride)] [Dexair{17}{43}{81} (sodium bisulfite 0.1%) (benzalkonium chloride)] [Dexotic{10}{70}] [Ocu-Dex] [Storz-Dexa][Generic]{70}{134}

Canada—


0.1% (phosphate) (Rx) [Decadron{45}{126} (sodium bisulfite 0.1%) (benzalkonium chloride)] [Diodex{29} (disodium edetate) (benzalkonium chloride)] [PMS-Dexamethasone Sodium Phosphate{05}] [R.O.-Dexasone{11} (benzalkonium chloride)] [Spersadex{12} (disodium edetate) (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.



FLUOROMETHOLONE


Ophthalmic Dosage Forms

FLUOROMETHOLONE OPHTHALMIC OINTMENT

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of a 0.1% ointment one to three times a day. {22} {47}


Note: In severe conditions, treatment may be initiated with application every four hours, with dosage gradually being decreased as inflammation subsides. {22} {47}


Usual pediatric dose
See Usual adult and adolescent dose .

Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


0.1% (Rx) [FML S.O.P{22}{47}{116} (phenylmercuric acetate)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.



FLUOROMETHOLONE OPHTHALMIC SUSPENSION USP

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.1% or 0.25% suspension two to four times a day. {46} {48} {49}


Note: In severe conditions, treatment may be initiated with 1 or 2 drops every hour, with dosage gradually being decreased as inflammation subsides. {46} {48} {49}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


0.1% (Rx) [Fluor-Op{49} (benzalkonium chloride)] [FML Liquifilm{46}{118} (benzalkonium chloride)]


0.25% (Rx) [FML Forte{48}{117} (benzalkonium chloride)]

Canada—


0.1% (Rx) [FML Liquifilm{50}{86}{109} (benzalkonium chloride)]


0.25% (Rx) [FML Forte{51}{87}{108} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing. {46} {48} {49}

Auxiliary labeling:
   • For the eye.
   • Shake well. {46} {48} {49}

Note: Dispense in original unopened container.



FLUOROMETHOLONE ACETATE OPHTHALMIC SUSPENSION

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.1% suspension two to four times a day. {67}


Note: In severe conditions, treatment may be initiated with 2 drops every two hours during the initial twenty-four to forty-eight hours. Dosage should be gradually decreased as inflammation subsides. {67}


Usual pediatric dose
See Usual adult and adolescent dose . {67}

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.1% (Rx) [Eflone{03}] [Flarex{119} (benzalkonium chloride)]

Canada—


0.1% (Rx) [Flarex{67}{89}{130} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {67}

Auxiliary labeling:
   • For the eye.
   • Shake well. {67}


HYDROCORTISONE


Ophthalmic Dosage Forms

HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT USP

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of a 2.5% ointment three or four times a day initially, with frequency of application gradually being decreased as inflammation subsides. {60}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


2.5% (Rx) [Cortamed{60}{90}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.



MEDRYSONE


Ophthalmic Dosage Forms

MEDRYSONE OPHTHALMIC SUSPENSION USP

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 drop of a 1% suspension up to every four hours. {71} {79}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


1% (Rx) [HMS Liquifilm{71}{120} (benzalkonium chloride)]

Canada—


1% (Rx) [HMS Liquifilm{59}{79}{80}{107} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing. {71} {79}

Auxiliary labeling:
   • For the eye.
   • Shake well. {71}

Note: Dispense in original unopened container.



PREDNISOLONE


Ophthalmic Dosage Forms

PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION USP

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.12 to 1% suspension two to four times a day. {28} {52} {53} {54} {62} {95}


Note: In severe conditions, treatment may be initiated with 1 or 2 drops every hour, with dosage gradually being decreased as inflammation subsides. {28} {53} {54} {95}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.12% (Rx) [Pred Mild{53}{121} (sodium bisulfite) (benzalkonium chloride)]


0.125% (Rx) [Econopred{52}{123} (benzalkonium chloride)]


1% (Rx) [AK-Tate{62} (benzalkonium chloride)] [Econopred Plus{52}{124} (benzalkonium chloride)] [Ocu-Pred-A] [Predair A{28} (sodium bisulfite) (benzalkonium chloride)] [Pred Forte{54}{122} (sodium bisulfite) (benzalkonium chloride)] [Ultra Pred{10}][Generic]{10}

Canada—


0.12% (Rx) [Pred Mild{55}{91}{110} (sodium bisulfite) (benzalkonium chloride)][Generic]{131}


1% (Rx) [AK-Tate{58} (sodium bisulfite)] [Ophtho-Tate{85}{95}] [Pred Forte{55}{91}{111} (sodium bisulfite) (benzalkonium chloride)][Generic]{131}

Packaging and storage:
Store between 8 and 24 °C (46 and 75 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light. Protect from freezing. {53} {54} {62}

Auxiliary labeling:
   • For the eye.
   • Shake well. {53} {54}

Note: Dispense in original unopened container.



PREDNISOLONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Ophthalmic disorders (treatment)
Topical, to the conjunctiva, 1 or 2 drops of a 0.125 or 1% solution up to six times a day. {34} {65} {66}


Note: In severe conditions, treatment may be initiated with 1 or 2 drops every hour, with dosage gradually being decreased as inflammation subsides. {34} {65} {66}


Usual pediatric dose
See Usual adult and adolescent dose.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


0.125% (Rx) [AK-Pred{65}{125} (sodium bisulfite) (benzalkonium chloride)] [Inflamase Mild{66} (benzalkonium chloride)] [I-Pred{42}{72}{76} (sodium metabisulfite) (benzalkonium chloride)] [Lite Pred{10}] [Ocu-Pred] [Predair{32}{43} (sodium bisulfite) (benzalkonium chloride)][Generic]{63}


1% (Rx) [AK-Pred{65}{125} (sodium bisulfite) (benzalkonium chloride)] [Inflamase Forte{66} (benzalkonium chloride)] [I-Pred{42}{72}{76} (sodium metabisulfite) (benzalkonium chloride)] [Ocu-Pred Forte] [Predair Forte{33}{43} (sodium bisulfite) (benzalkonium chloride)][Generic]{64}{133}

Canada—


0.125% (Rx) [Inflamase Mild{34}{61}{92}{128} (benzalkonium chloride)]


1% (Rx) [Inflamase Forte{34}{61}{92}{127} (benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing. {65}

Auxiliary labeling:
   • For the eye.

Note: Dispense in original unopened container.




Revised: 08/12/1998
Interim revision:



References
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  1. Fluorometholone package insert (FML Forte, Allergan—US), Rev 7/86, Rec 1/87.
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  1. Fluorometholone package insert (FML Forte, Allergan—Canada), Rev 11/92, Rec 4/93.
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  1. Prednisolone package insert (Pred Mild, Allergan—Canada), Rev 11/92, Rec 4/93.
  1. Prednisolone package insert (Pred Forte, Allergan—Canada), Rev 11/92, Rec 4/93.
  1. Dexamethasone package insert (Maxidex, Alcon—Canada), Rec 7/93.
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  1. Dexamethasone package insert (AK-Dex, Akorn—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 202.
  1. Dexamethasone package insert (Maxidex, Alcon—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 221.
  1. Fluorometholone package insert (FML S.O.P., Allergan—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 244.
  1. Fluorometholone package insert (FML Forte, Allergan—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 245.
  1. Fluorometholone package insert (FML Liquifilm, Allergan—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 244.
  1. Fluorometholone package insert (Flarex, Alcon—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 215.
  1. Medrysone package insert (HMS Liquifilm, Allergan—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 247.
  1. Prednisolone package insert (Pred Mild, Allergan—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 254.
  1. Prednisolone package insert (Pred Forte, Allergan—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 251.
  1. Prednisolone package insert (Econopred, Alcon—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 214.
  1. Prednisolone package insert (Econopred Plus, Alcon—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 214.
  1. Prednisolone package insert (AK-Pred, Akorn—US). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Oradell, NJ: Medical Economics Company, 1993: 203.
  1. Dexamethasone package insert (Decadron, MSD—Canada). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 322.
  1. Prednisolone package insert (Inflamase Forte, Iolab—Canada). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 584.
  1. Prednisolone package insert (Inflamase Mild, Iolab—Canada). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 584.
  1. Betamethasone package insert (Betnesol, Glaxo—Canada). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 152.
  1. Fluorometholone package insert (Flarex, Alcon—Canada). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 458.
  1. Per telephone conversation on 9/28/93 with Kathy of Sabex—Canada, prednisolone acetate ophthalmic suspension is now available generically.
  1. Generic dexamethasone sodium phosphate ophthalmic ointment package insert (BW—US), Rev 8/92, Rec 8/93.
  1. Generic prednisolone sodium phosphate ophthalmic solution package insert (BW—US), Rev 1/93, Rec 8/93.
  1. Generic dexamethasone sodium phosphate ophthalmic solution package insert (BW—US), Rev 6/91, Rec 8/93.
  1. Reviewers' responses to Ophthalmic Corticosteroids Advisory Panel Ballot of 2/2/94.
  1. Reviewer comment, 12/15/93.
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