Introduction

A synthetic nonfluorinated corticosteroid.

Uses for prednisoLONE (EENT)

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).

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

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye; 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. If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks. (See Infections under Cautions.)

prednisoLONE (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eyes as an ophthalmic ointment, solution, or suspension.

Not for injection.

Shake suspension well prior to each use.

Avoid contamination of the preparation container.

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.

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

Dosage

Available as prednisolone acetate or prednisolone sodium phosphate, alone or in fixed combination with anti-infectives. Potency of prednisolone acetate preparations expressed in terms of the salt. Potency of sodium phosphate preparations expressed in terms of prednisolone phosphate or prednisolone sodium phosphate.

Pediatric Patients

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

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

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

Bacterial Ophthalmic Infections

Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10%

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. Reduce dosing frequency as infection improves.

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. Reduce dosing frequency as infection improves.

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%

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

Adults

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

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. Avoid long-term therapy. Do not discontinue prematurely.

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

Ophthalmic Inflammation

Prednisolone Acetate 0.12% or 1%

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

Prednisolone Sodium Phosphate 0.125% or 1%

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. 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.

Bacterial Ophthalmic Infections

Prednisolone Acetate 0.5%, Neomycin Sulfate 0.35%, and Polymyxin B Sulfate 10,000 units

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

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

Prednisolone Acetate 0.6% and Gentamicin Sulfate 0.3%

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

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.

Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10%

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. Reduce dosing frequency as infection improves.

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

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%.

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

Special Populations

No special population dosage recommendations at this time.

Contraindications

• Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).

• Mycobacterial infection of the eye.

• Fungal disease of ocular structures.

• Acute, purulent, untreated infections of the eye.

• After uncomplicated removal of a corneal foreign body.

• Known hypersensitivity to prednisolone, other corticosteroids, or any ingredient in the formulation.

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. Use with caution in glaucoma because IOP may increase.

If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.

Use of high-dose corticosteroids may delay healing. Use after cataract surgery may delay healing and increase incidence of bleb formation.

Infections

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. (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.

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.

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).

Reevaluate patient if improvement does not occur after 2 days.

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea. Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or who are receiving corticosteroid therapy.

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).

Corneal Reepithelialization

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.

Caution if used in nursing women. Some manufacturers recommend that women discontinue nursing or the drug.

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.

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.

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.

Common Adverse Effects

Elevated IOP, transient stinging or burning, blurred vision, ocular irritation, foreign body sensation.

Administration

Ophthalmic Administration

Apply topically to the eyes as an ophthalmic ointment, solution, or suspension.

Not for injection.

Shake suspension well prior to each use.

Avoid contamination of the preparation container.

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.

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

Dosage

Available as prednisolone acetate or prednisolone sodium phosphate, alone or in fixed combination with anti-infectives. Potency of prednisolone acetate preparations expressed in terms of the salt. Potency of sodium phosphate preparations expressed in terms of prednisolone phosphate or prednisolone sodium phosphate.

Pediatric Patients

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

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

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

Bacterial Ophthalmic Infections

Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10%

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. Reduce dosing frequency as infection improves.

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. Reduce dosing frequency as infection improves.

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%

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

Adults

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

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. Avoid long-term therapy. Do not discontinue prematurely.

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

Ophthalmic Inflammation

Prednisolone Acetate 0.12% or 1%

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

Prednisolone Sodium Phosphate 0.125% or 1%

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. 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.

Bacterial Ophthalmic Infections

Prednisolone Acetate 0.5%, Neomycin Sulfate 0.35%, and Polymyxin B Sulfate 10,000 units

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

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

Prednisolone Acetate 0.6% and Gentamicin Sulfate 0.3%

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

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.

Prednisolone Acetate 0.2% and Sulfacetamide Sodium 10%

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. Reduce dosing frequency as infection improves.

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

Prednisolone Sodium Phosphate 0.25% and Sulfacetamide Sodium 10%.

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

Special Populations

No special population dosage recommendations at this time.