Prednisolone Acetate eent

Pronunciation

Class: Corticosteroids
Note: This monograph also contains information on Prednisolone Sodium Phosphate
ATC Class: S02BA03
VA Class: OP300
Chemical Name: 11ß,17,21-trihydroxypregna-1,4-diene-3,20-dione
Molecular Formula: C21H28O5
CAS Number: 52-21-1
Brands: AK-Pred, Blephamide, Econopred, Inflamase, Poly-Pred, Pred, Pred-G, Vasocidin

Introduction

A synthetic nonfluorinated corticosteroid.a b

Uses for Prednisolone Acetate

Ophthalmic Inflammation

Symptomatic relief of corticosteroid-responsive allergic and inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (e.g., allergic or vernal conjunctivitis, acne rosacea keratitis, superficial punctate keratitis, herpes zoster keratitis, uveitis, iritis, cyclitis).b g h i

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Treatment of corneal, conjunctival, and scleral injuries from chemical, radiation, or thermal burns or penetration of foreign bodies.b g h

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;c d e f g j k used in fixed combination with gentamicin sulfate, sulfacetamide sodium, or the combination of neomycin sulfate and polymyxin b sulfate when such combination therapy is indicated.c d e f j k If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.g (See Infections under Cautions.)

Prednisolone Acetate Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eyes as an ophthalmic ointment, solution, or suspension.a b c d e f h i j k

Not for injection.c d e f h j

Shake suspension well prior to each use.b c e i j

Avoid contamination of the preparation container.a b c d e f h i j k

May use ointment at night in conjunction with daytime use of a suspension or solution to reduce the frequency of applications required with the liquid dosage forms.a

To treat eyelids, instill into the eye, then close the eye and rub the excess onto the lids and lid margins.c

Dosage

Available as prednisolone acetate or prednisolone sodium phosphate, alone or in fixed combination with anti-infectives.b c d e f h i j k Potency of prednisolone acetate preparations expressed in terms of the salt.b c e f i j k Potency of sodium phosphate preparations expressed in terms of prednisolone phosphate or prednisolone sodium phosphate.a d h

Pediatric Patients

If improvement does not occur after 2 days, reevaluate the patient.d f j

Duration of therapy ranges from a few days to several weeks; depending on the type and severity of the disease and response to therapy.a Avoid long-term therapy.a Do not discontinue prematurely.d f j

When discontinuing therapy in chronic conditions, gradually taper dosing frequency to avoid exacerbation of the disease.a d f j

Bacterial Ophthalmic Infections
Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10%
Ophthalmic Ointment

Children ≥6 years of age: Apply 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3–4 times during the day and once or twice during the night.f Reduce dosing frequency as infection improves.f

Ophthalmic Suspension

Children ≥6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.j Reduce dosing frequency as infection improves.j

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%
Ophthalmic Solution

Children ≥6 years of age: 2 drops into the conjunctival sac of the affected eye(s) every 4 hours.d Reduce dosing frequency as infection improves.d

Adults

If improvement does not occur after 2 days, reevaluate the patient.b f i j k

Duration of therapy ranges from a few days to a few weeks; depending on the type and severity of the disease and response to therapy.a h Avoid long-term therapy.a Do not discontinue prematurely.b f j k

When discontinuing therapy in chronic conditions, gradually taper dosing frequency to avoid exacerbation of the disease.a f j

Ophthalmic Inflammation
Prednisolone Acetate 0.12% or 1%
Ophthalmic Suspension

1 or 2 drops into the conjunctival sac of the affected eye(s) 2–4 times daily.b i During initial 24–48 hours, may increase dosing frequency if necessary.b i

Prednisolone Sodium Phosphate 0.125% or 1%
Ophthalmic Solution

Initially, depending on severity of inflammation, 1 or 2 drops into the conjunctival sac of the affected eye(s) up to every hour during the day and every 2 hours during the night as necessary.h When a favorable response is attained, reduce dosing frequency to 1 drop every 4 hours and subsequently to 1 drop 3 or 4 times daily.h

Bacterial Ophthalmic Infections
Prednisolone Acetate 0.5%, Neomycin Sulfate 0.35%, and Polymyxin B Sulfate 10,000 units
Ophthalmic Suspension

1 or 2 drops into the conjunctival sac of the affected eye(s) every 3 or 4 hours, or more frequently as required.c For acute infection, may administer every 30 minutes.c Reduce dosing frequency as infection improves.c

To treat eyelids: 1 or 2 drops into the affected eye(s) every 3 to 4 hours.c (See Administration under Dosage and Administration.)

Prednisolone Acetate 0.6% and Gentamicin Sulfate 0.3%
Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 1–3 times daily.k

Ophthalmic Suspension

Initial 24–48 hours, up to 1 drop into the conjunctival sac of the affected eye(s) every hour; thereafter, 1 drop 2–4 times daily.e

Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10%
Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 3–4 times during the day and once or twice during the night.f Reduce dosing frequency as infection improves.f

Ophthalmic Suspension

2 drops into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime.j Reduce dosing frequency as infection improves.j

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%.
Ophthalmic Solution

2 drops into the conjunctival sac of the affected eye(s) every 4 hours.d Reduce dosing frequency as infection improves.d

Special Populations

No special population dosage recommendations at this time.b c d e f h i j k

Cautions for Prednisolone Acetate

Contraindications

  • Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).b c d e f g h i j k

  • Mycobacterial infection of the eye.b c d e f g h i j k

  • Fungal disease of ocular structures.b c d e f g h i j k

  • Acute, purulent, untreated infections of the eye.b

  • After uncomplicated removal of a corneal foreign body.c h

  • Known hypersensitivity to prednisolone, other corticosteroids, or any ingredient in the formulation.b c d e f g h i j k

Warnings/Precautions

Warnings

Ocular Effects

Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.b c d e f g h i j k Use with caution in glaucoma because IOP may increase.b c d e f i j k

If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.b c d e f g h i j k

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.b c d e f g h i j k

Use of high-dose corticosteroids may delay healing.b c d e f g i j k Use after cataract surgery may delay healing and increase incidence of bleb formation.b d e f g i j k

Infections

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.b c d e f g h i j k

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.b c d e f h i j k (See Contraindications under Cautions.)

Herpes Simplex

Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.b c d e f g h i j k

Sensitivity Reactions

Sulfite Sensitivity

Some formulations of prednisolone contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.b g i

General Precautions

Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of ointment or 20 mL of suspension or solution should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).b c d e f i j k

Reevaluate patient if improvement does not occur after 2 days.b d e f i j k

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.b c d e f i j k Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or who are receiving corticosteroid therapy.b c d e f h i j k

Use of Fixed Combinations

When prednisolone acetate or prednisolone sodium phosphate is used in fixed combination with gentamicin sulfate, sulfacetamide sodium, or the combination of neomycin sulfate and polymyxin B sulfate, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).d f

Corneal Reepithelialization

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.f g

Specific Populations

Pregnancy

Category C.b c d e f h i j k

Lactation

Not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.b d e f h i j k

Caution if used in nursing women.c h Some manufacturers recommend that women discontinue nursing or the drug.b i

Pediatric Use

Safety and efficacy of ophthalmic preparations containing prednisolone acetate or prednisolone sodium phosphate in fixed combination with sulfacetamide sodium not established in children <6 years of age.d f j

Safety and efficacy of other ophthalmic prednisolone preparations (prednisolone sodium phosphate alone, prednisolone acetate alone or in fixed combination with gentamicin or with neomycin sulfate and polymyxin B sulfate) not established in children of any age.b c e h i k

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.b c e i k

Common Adverse Effects

Elevated IOP,b c d e f h i j k transient stinging or burning,b e h i blurred vision,g i ocular irritation,b e k foreign body sensation.i

Prednisolone Acetate Pharmacokinetics

Absorption

Bioavailability

Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs.g

Distribution

Extent

Systemically absorbed corticosteroids are distributed into milk; not known whether topical corticosteroids could produce detectable levels in human milk.b d e f h i j k

Stability

Storage

Ophthalmic

Sulfacetamide-containing solutions darken on prolonged standing and exposure to heat and light.d j Discard preparations that have darkened; yellow discoloration does not affect activity.d j

Ointment

Gentamicin and prednisolone acetate: 15–25°C.k

Sulfacetamide sodium and prednisolone acetate: 15–25°C.f

Solution

Prednisolone sodium phosphate: 15–25°C; protect from light.h

Sulfacetamide sodium and prednisolone acetate: 15–25°C; protect from heat and light.d Do not freeze.d

Suspension

Gentamicin and prednisolone acetate: 15–25°C; do not freeze.e Do not expose to ≥40°C.e

Prednisolone acetate (Pred Forte): ≤25°C; do not freeze.i

Prednisolone acetate (Pred-Mild): 15–30°C; do not freeze.b

Prednisolone acetate, neomycin sulfate, polymyxin B sulfate: 15–25°C; do not freeze.c

Sulfacetamide sodium and prednisolone acetate: 8–24°C; protect from light and freezing.j

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Ophthalmic

Solutions and Suspensions

Sulfacetamide sodium and prednisolone acetate or prednisolone sodium phosphate preparations: Incompatible with preparations containing silver.d f j

Actions

  • Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.c d e f g h j k

  • Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.b g i

Advice to Patients

  • Importance of discontinuing therapy and consulting a clinician if inflammation or pain persists for >48 hours or worsens.b c d e f i j k

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.b c d e f g h i j k

  • Advise patient not to share the drug with any other person.b c d e f i j k

  • Importance of not wearing contact lenses if signs or symptoms of eye infections occur.c j

  • Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ≥5 minutes after administration.l

  • Importance of informing a clinician if another eye condition (e.g., trauma, surgery, infection) develops during ophthalmic therapy.g

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b c d e f g h i j k

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d e f g h i j k

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Ophthalmic

Suspension

0.12%

Pred Mild (with benzalkonium chloride and sodium bisulfite)

Allergan

1%

Econopred Plus (with benzalkonium chloride)

Alcon

Pred Forte (with benzalkonium chloride and sodium bisulfite)

Allergan

Prednisolone Acetate

Falcon

Gentamicin Sulfate and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 0.6%

Pred-G (with chlorobutanol)

Allergan

Suspension

Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 1%

Pred-G (with benzalkonium chloride; viscous)

Allergan

Neomycin and Polymyxin B Sulfates and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Prednisolone Acetate 0.5%

Poly-Pred (with propylene glycol and thimerosal; viscous)

Allergan

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sulfacetamide Sodium and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%

Blephamide (with phenylmercuric acetate)

Allergan

Suspension

10% Sulfacetamide Sodium and Prednisolone Acetate 0.2%*

Blephamide (with benzalkonium chloride; viscous)

Allergan

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prednisolone Sodium Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.125% (0.11% of prednisolone phosphate)*

Inflamase Mild (with benzalkonium chloride)

Novartis

1% (0.9% of prednisolone phosphate)

AK-Pred (with benzalkonium chloride and sodium bisulfite)

Akorn

Inflamase Forte (with benzalkonium chloride)

Novartis

Prednisolone Sodium Phosphate

Bausch & Lomb

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prednisolone Sodium Phosphate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.25% (0.23% of prednisolone phosphate) with Sulfacetamide Sodium 10%*

Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Bausch & Lomb, Falcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Blephamide 10-0.2% Suspension (ALLERGAN): 5/$70.99 or 15/$199.97

Blephamide 10-0.2% Suspension (ALLERGAN): 10/$105.99 or 30/$295.96

Econopred Plus 1% Suspension (ALCON VISION): 10/$57.99 or 30/$165.98

Omnipred 1% Suspension (ALCON VISION): 10/$95.93 or 30/$268.16

Pred Forte 1% Suspension (ALLERGAN): 5/$42.00 or 15/$111.29

Pred Forte 1% Suspension (ALLERGAN): 10/$69.99 or 30/$209.93

Pred Forte 1% Suspension (ALLERGAN): 15/$104.99 or 45/$293.98

Pred Mild 0.12% Suspension (ALLERGAN): 5/$39.29 or 15/$93.86

Pred Mild 0.12% Suspension (ALLERGAN): 10/$46.20 or 30/$121.80

Pred-G 0.3-1% Suspension (ALLERGAN): 5/$39.99 or 15/$99.97

PrednisoLONE Acetate 1% Suspension (SANDOZ): 5/$19.99 or 15/$45.97

PrednisoLONE Acetate 1% Suspension (SANDOZ): 10/$25.99 or 30/$59.97

PrednisoLONE Acetate 1% Suspension (SANDOZ): 15/$33.99 or 45/$95.98

PrednisoLONE Sodium Phosphate 1% Solution (BAUSCH &amp; LOMB): 10/$72.99 or 30/$210.96

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 5/$25.99 or 15/$56.97

Sulfacetamide-Prednisolone 10-0.23% Solution (BAUSCH &amp; LOMB): 10/$30.99 or 20/$53.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2008. McEvoy GK, ed. Prednisolone. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008: 2887-8.

b. Allergan, Inc. Pred-Mild (prednisolone acetate ophthalmic suspension) prescribing information. Irvine, CA; 2004 Jun.

c. Allergan, Inc. Poly-Pred (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension) prescribing information. Irvine, CA; 2004 Dec.

d. Falcon Pharmaceuticals, Ltd. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution prescribing information. Ft Worth, TX; 2007 Jul.

e. Allergan, Inc. Pred G (gentamicin sulfate 0.3% and prednisolone acetate 0.1% ophthalmic suspension) prescribing information. Irvine, CA; 2005 Dec .

f. Allergan, Inc. Blephamide (sulfacetamide sodium 10% and prednisolone acetate 0.2% ophthalmic ointment) prescribing information. Irvine, CA; 2004 Sep.

g. AHFS drug information 2008. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health Systems Pharmacists; 2008: 2867-9.

h. Novartis Ophthalmics. Inflamase Mild 1/8% and Inflamase Forte 1% (prednisolone sodium phosphate) ophthalmic solution prescribing information. Duluth, GA; 2001 Jul.

i. Allergan, Inc. Pred-Forte (prednisolone acetate ophthalmic suspension) prescribing information. Irvine, CA; 2004 Mar.

j. Allergan, Inc. Blephamide (sulfacetamide sodium 10% and prednisolone acetate 0.2% ophthalmic suspension) prescribing information. Irvine, CA; 2004 Jun.

k. Allergan, Inc. Pred-G (gentamicin sulfate 0.3% and prednisolone acetate 0.6% ophthalmic ointment) prescribing information. Irvine, CA; 2004 Jan.

l. Christensen MT, Barry JR, Twiner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-31. [PubMed 9800062]

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