Hydrocortisone (EENT)

Drug class: Antineoplastic Agents

Usage of 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.

Relate drugs

How to use Hydrocortisone (EENT)

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.

Warnings

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.

    What other drugs will affect Hydrocortisone (EENT)

    Specific Laboratory Test

    Test

    Interaction

    Test for adrenal steroids

    Possible decrease in urinary excretion of 17-hydroxycorticosteroids from excessive systemic levels of hydrocortisone

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