Hydrocortisone (EENT) (Monograph)

Drug class: Corticosteroids


Hydrocortisone (EENT) is also contained as an ingredient in the following combinations:
Colistin and Neomycin Sulfates and Hydrocortisone Acetate
Hydrocortisone and Acetic Acid
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate
Neomycin and Polymyxin B Sulfates and Hydrocortisone
Polymyxin B Sulfates and Hydrocortisone

Introduction

A corticosteroid secreted by the adrenal cortex.

Uses for Hydrocortisone (EENT)

Ophthalmic Inflammation

Treatment of corticosteroid-responsive ocular inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Treatment of chronic anterior uveitis.

Treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Commercially available only in fixed combination with anti-infectives; use only when such combination therapy is indicated. (See Bacterial Ophthalmic Infections under Uses.)

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 neomycin and polymyxin B sulfates, or with neomycin and polymyxin B sulfates and bacitracin zinc 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.)

Bacterial Otic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some cases of bacterial otitis externa; used in fixed combination with acetic acid, ciprofloxacin hydrochloride, colistin sulfate and neomycin sulfate, or neomycin and polymyxin B sulfates when such combination therapy is indicated. If an otic corticosteroid is used in combination with an otic anti-infective, weigh benefits against risks.

Hydrocortisone (EENT) Dosage and Administration

Administration

Apply topically to the eye or ear.

Shake suspension well prior to use.

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment or suspension.

Not for injection.

Avoid contamination of the preparation container.

Otic Administration

Apply topically to the ear(s) as an otic solution or suspension.

Not for injection. Do not instill otic preparations into the eye.

Clean and dry ear canal prior to administration.

To avoid dizziness that may result from instilling a cold preparation into the ear, warm the preparation by holding the bottle in the hands for 1–2 minutes prior to administration. (See Advice to Patients.)

Lie with the affected ear upward prior to drug instillation. Remain in this position for 5 minutes following drug administration to ease penetration of drops into the ear canal.

Use sparingly to prevent an accumulation of excess debris in the ear canal.

Dosage

Commercially available only in fixed combination with anti-infectives; available as hydrocortisone or hydrocortisone acetate; dosage of hydrocortisone acetate expressed in terms of the salt.

Pediatric Patients

Bacterial Otic Infections

Hydrocortisone and Acetic Acid

Otic Solution

Children ≥3 years of age: Insert a cotton wick saturated with the solution into the ear canal; keep the wick moist by adding 3 or 4 drops of the drug solution every 4–6 hours. The wick may be removed after 24 hours, but continue to instill 3 or 4 drops 3 or 4 times daily as long as indicated.

Hydrocortisone and Ciprofloxacin Hydrochloride

Otic Suspension

Children ≥1 year of age: Instill 3 drops into affected ear(s) twice daily for 7 days.

Hydrocortisone Acetate, Colistin and Neomycin Sulfates

Otic Suspension

Pediatric patients: Instill 4 drops into affected ear(s) 3 or 4 times daily for up to 10 days. Alternatively, a cotton wick saturated with the suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.

Hydrocortisone and Neomycin and Polymyxin B Sulfates

Otic Solution or Suspension

Children ≥2 years of age: Instill 3 drops into affected ear(s) 3 or 4 times daily for up to 10 days. Alternatively, a cotton wick saturated with the solution or suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.

Adults

Ophthalmic Inflammation and Bacterial Ophthalmic Infections

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

Duration of therapy depends on the type and severity of the disease and response to therapy.

Gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.

Hydrocortisone and Neomycin and Polymyxin B Sulfates

Ophthalmic Suspension

Instill 1 or 2 drops into affected eye(s) every 3–4 hours, or more frequently, as necessary.

Hydrocortisone and Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Ophthalmic Ointment

Apply small amount to affected eye(s) every 3–4 hours.

Bacterial Otic Infections

Hydrocortisone and Acetic Acid

Otic Solution

Insert a cotton wick saturated with the solution into the ear canal; keep the wick moist by adding 3–5 drops of the drug solution every 4–6 hours. The wick may be removed after 24 hours, but continue to instill 5 drops 3 or 4 times daily as long as indicated.

Hydrocortisone and Ciprofloxacin Hydrochloride

Otic Suspension

Instill 3 drops into affected ear(s) twice daily for 7 days.

Hydrocortisone Acetate and Colistin and Neomycin Sulfates

Otic Suspension

Instill 5 drops into affected ear(s) 3 or 4 times daily for up to 10 days. Alternatively, a cotton wick saturated with the suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.

Hydrocortisone and Neomycin and Polymyxin B Sulfates

Otic Solution or Suspension

Instill 4 drops into affected ear(s) 3 or 4 times daily for up to 10 days. Alternatively, a cotton wick saturated with the solution or suspension may be packed into the ear canal; keep the wick moist by adding additional drug every 4 hours; replace the wick at least once every 24 hours.

Prescribing Limits

Pediatric Patients

Bacterial Otic Infections

Otic

Otic preparations: Maximum 10 days of therapy.

Adults

Bacterial Otic Infections

Otic

Otic preparations: Maximum 10 days of therapy.

Special Populations

No special population dosage recommendations at this time.

Cautions for Hydrocortisone (EENT)

Contraindications

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

Ophthalmic Preparations

• 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.

Otic Preparations

• Known or suspected viral infection (e.g., herpes simplex virus, vaccinia, varicella-zoster virus) of the external ear canal.

• Fungal disease of otic structures.

• Acute, purulent, untreated infections of the ear.

• Patients with perforated tympanic membrane. (See Perforated Tympanic Membrane under Cautions.)

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 intraocular pressure (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 and 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

See Contraindications under Cautions.

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.

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.

Perforated Tympanic Membrane

Most manufacturers state that otic preparations should not be used in patients with perforated tympanic membrane. Ciprofloxacin hydrochloride and hydrocortisone otic suspension is not sterile and is contraindicated in patients with perforated tympanic membrane.

Sensitivity Reactions

Sulfite Sensitivity

Some otic preparations may 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 infections in patients with persistent corneal ulceration who have been or who are receiving corticosteroid therapy.

Use of Fixed Combinations

When hydrocortisone or hydrocortisone acetate is used in fixed combination with anti-infectives, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).

Ophthalmic Ointments

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.

Specific Populations

Pregnancy

Category C.

Lactation

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

Ophthalmic preparations: Discontinue nursing or the drug.

Otic preparations: Caution if used in nursing women.

Pediatric Use

Safety and efficacy of ophthalmic administration not established.

Safety and efficacy of otic administration of hydrocortisone in fixed combination with acetic acid not established in children <3 years of age.

Safety and efficacy of otic administration of hydrocortisone in fixed combination with ciprofloxacin hydrochloride, with colistin sulfate and neomycin sulfate, or with neomycin and polymyxin B sulfates, not established in children <2 years of age. Manufacturer states that no known safety concerns would preclude use of hydrocortisone and ciprofloxacin hydrochloride otic suspension in children ≥1 year of age.

Geriatric Use

Ophthalmic therapy: No substantial differences in safety and efficacy relative to younger individuals.

Otic therapy: Clinical trials included insufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; other clinical experience has not identified differences in response.

Common Adverse Effects

Ophthalmic administration: Elevated IOP, transient stinging or burning, blurred vision, local irritation.

Otic administration: Headache, pruritus, transient stinging or burning.

Drug Interactions

Specific Laboratory Test

Hydrocortisone (EENT) Pharmacokinetics

Absorption

Bioavailability

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

Stability

Storage

Ophthalmic

Ointment

15–25°C.

Suspension

20–25°C.

Otic

Solution

Hydrocortisone and acetic acid: Tightly closed containers at 15–30°C; do not freeze.

Hydrocortisone and neomycin and polymyxin B sulfates: 15–25°C.

Suspension

Hydrocortisone and ciprofloxacin hydrochloride: <25°C; protect from light and freezing.

Hydrocortisone acetate, colistin and neomycin sulfates: 20–25°C.

Hydrocortisone and neomycin and polymyxin B sulfates: 15–25°C.

Actions

• Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.

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

Advice to Patients

• Importance of discontinuing ophthalmic therapy and consulting a clinician if inflammation or pain persists for >48 hours or worsens.

• Importance of learning and adhering to proper ophthalmic administration techniques to avoid contamination of the tip of the container.

• Importance of warning the patient not to share the drug.

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

• Inform patients to warm the otic suspension by holding the bottle in the hands for 1–2 minutes prior to administration to avoid dizziness resulting from placing a cold preparation into the ear.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

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

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

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