Hydrocortisone Acetate eent

Class: Corticosteroids
ATC Class: S03CA04
VA Class: OP300
Chemical Name: 11ß, 17, 21-trihydroxypregn-4-ene-3,20-dione
CAS Number: 50-23-7
Brands: Acetasol HC, Cipro HC, Coly-Mycin, Cortisporin, PediOtic

Introduction

A corticosteroid secreted by the adrenal cortex.^a

Uses for Hydrocortisone Acetate

Ophthalmic Inflammation

Treatment of corticosteroid-responsive ocular inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.^{b d k}

Treatment of chronic anterior uveitis.^{d k}

Treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.^{b d k}

Commercially available only in fixed combination with anti-infectives; use only when such combination therapy is indicated.^{d k} (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;^b 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.^{d k} If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.^b (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.^{b c g h i j l} If an otic corticosteroid is used in combination with an otic anti-infective, weigh benefits against risks.^b

Hydrocortisone Acetate Dosage and Administration

Administration

Apply topically to the eye or ear.^{a c d g h i j k l}

Shake suspension well prior to use.^{c d g i j}

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment or suspension.^{a d k}

Not for injection.^{d k}

Avoid contamination of the preparation container.^{a b d k}

Otic Administration

Apply topically to the ear(s) as an otic solution or suspension.^{b c g h i j l}

Not for injection.^j Do not instill otic preparations into the eye.^{c g h i j}

Clean and dry ear canal prior to administration.^{a c g h i l}

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.^j (See Advice to Patients.)

Lie with the affected ear upward prior to drug instillation.^{c g h i} Remain in this position for 5 minutes following drug administration to ease penetration of drops into the ear canal.^{c g h i}

Use sparingly to prevent an accumulation of excess debris in the ear canal.^{a b}

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.^{a c d g h i j k l}

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.^l 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.^l

Hydrocortisone and Ciprofloxacin Hydrochloride

Otic Suspension

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

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.ⁱ 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.ⁱ

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.^{c g h} 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.^{c g h}

Adults

Ophthalmic Inflammation and Bacterial Ophthalmic Infections

If improvement does not occur after 2 days, reevaluate the patient.^{d k}

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

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

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.^d

Hydrocortisone and Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Ophthalmic Ointment

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

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.^l The wick may be removed after 24 hours, but continue to instill 5 drops 3 or 4 times daily as long as indicated.^l

Hydrocortisone and Ciprofloxacin Hydrochloride

Otic Suspension

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

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.ⁱ 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.ⁱ

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.^{c g h} 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.^{c g h}

Prescribing Limits

Pediatric Patients

Bacterial Otic Infections

Otic

Otic preparations: Maximum 10 days of therapy.^{c g k}

Adults

Bacterial Otic Infections

Otic

Otic preparations: Maximum 10 days of therapy.^{c g k}

Special Populations

No special population dosage recommendations at this time.^{c d g h i j k l}

Cautions for Hydrocortisone Acetate

Contraindications

• 
  

  Known hypersensitivity to hydrocortisone, other corticosteroids, or any ingredient in the formulation.^{b c d g h i j k l}

  
  

• Ophthalmic Preparations


• 
  

  Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).^{b d k}

  
  


• 
  

  Mycobacterial infection of the eye.^{b d k}

  
  


• 
  

  Fungal disease of ocular structures.^{b d k}

  
  


• 
  

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

  
  

• Otic Preparations


• 
  

  Known or suspected viral infection (e.g., herpes simplex virus, vaccinia, varicella-zoster virus) of the external ear canal.^{c g h i j l}

  
  


• 
  

  Fungal disease of otic structures.^b

  
  


• 
  

  Acute, purulent, untreated infections of the ear.^b

  
  


• 
  

  Patients with perforated tympanic membrane.^{j l} (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.^{b d k} Use with caution in glaucoma because intraocular pressure (IOP) may increase.^{b d k}

If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.^{b d k}

In conditions causing thinning of the cornea and sclera, perforations reported with use of topical corticosteroids.^{b d k}

Use of high-dose corticosteroids may delay healing.^{b d k} Use after cataract surgery may delay healing and increase incidence of bleb formation.^{b d k}

Infections

See Contraindications under Cautions.

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.^{b d k}

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.^{d k}

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.^{d k}

Perforated Tympanic Membrane

Most manufacturers state that otic preparations should not be used in patients with perforated tympanic membrane.^{c g h l} Ciprofloxacin hydrochloride and hydrocortisone otic suspension is not sterile and is contraindicated in patients with perforated tympanic membrane.^j

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.^h

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).^{d k}

Reevaluate patient if improvement does not occur after 2 days.^{d k}

Fungal Infections

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

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).^{c d g h i j k l}

Ophthalmic Ointments

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.^{b k}

Specific Populations

Pregnancy

Category C.^{c d g h i j k}

Lactation

Not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.^{d k}

Ophthalmic preparations: Discontinue nursing or the drug.^{d k}

Otic preparations: Caution if used in nursing women.^{c g h i}

Pediatric Use

Safety and efficacy of ophthalmic administration not established.^{d k}

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

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.^{c g h j} Manufacturer states that no known safety concerns would preclude use of hydrocortisone and ciprofloxacin hydrochloride otic suspension in children ≥1 year of age.^j

Geriatric Use

Ophthalmic therapy: No substantial differences in safety and efficacy relative to younger individuals.^{d k}

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.^{c g h}

Common Adverse Effects

Ophthalmic administration: Elevated IOP,^{d k} transient stinging or burning,^b blurred vision,^b local irritation.^{d k}

Otic administration: Headache,^j pruritus,^j transient stinging or burning.^l

Interactions for Hydrocortisone Acetate

Specific Laboratory Test

Test	Interaction
Test for adrenal steroids	Possible decrease in urinary excretion of 17-hydroxycorticosteroids from excessive systemic levels of hydrocortisonec g i j

Hydrocortisone Acetate Pharmacokinetics

Absorption

Bioavailability

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

Stability

Storage

Ophthalmic

Ointment

15–25°C.^k

Suspension

20–25°C.^d

Otic

Solution

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

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

Suspension

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

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

Hydrocortisone and neomycin and polymyxin B sulfates: 15–25°C.^{c g}

ActionsActions

• 
  

  Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.^{b c d g h i k}

  
  


• 
  

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

  
  

Advice to Patients

• 
  

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

  
  


• 
  

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

  
  


• 
  

  Importance of warning the patient not to share the drug.^{d k}

  
  


• 
  

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

  
  


• 
  

  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.^j

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{c d 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 g h i j k}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{b c d g h i j k l} (See Cautions.)

  
  

Preparations

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

Hydrocortisone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder

Hydrocortisone and Acetic Acid

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Otic	Solution	1% Hydrocortisone and Acetic Acid Glacial 2% (of acetic acid)	Acetasol HC Otic Solution	Actavis
			Hydrocortisone 1% and Acetic Acid 2% Otic Solution (with benzethonium chloride and propylene glycol diacetate)	Taro

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

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Ointment	Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%*	Cortisporin Ophthalmic Ointment	Monarch

Neomycin and Polymyxin B Sulfates and Hydrocortisone

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 Hydrocortisone 1%	Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension (with propylene glycol and thimerosal)	Falcon
Otic	Solution	Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%	Cortisporin Otic Solution (with potassium metabisulfite and propylene glycol)	Monarch
			Neomycin Sulfate, Polymyxin B Sulfate, and Hydrocortisone Otic Solution	Bausch & Lomb
			Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution (with potassium metabisulfite and propylene glycol)	Falcon
	Suspension	Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%	Neomycin Sulfate, Polymyxin B Sulfate, and Hydrocortisone Otic Solution	Bausch & Lomb
			Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution (with thimerosal and propylene glycol)	Falcon
			PediOtic Suspension (with propylene glycol and thimerosal)	Monarch

Hydrocortisone Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Otic	Suspension	1% with Ciprofloxacin Hydrochloride 0.2% (of ciprofloxacin)	Cipro HC Otic Drops (with benzyl alcohol 0.9%)	Alcon

Hydrocortisone Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder

Colistin and Neomycin Sulfates and Hydrocortisone Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Otic	Suspension	Colistin Sulfate 0.3% (of colistin), Neomycin Sulfate 0.33% (of neomycin), and Hydrocortisone Acetate 1%	Coly-Mycin S Otic with Neomycin and Hydrocortisone (with thimerosal and thonzonium bromide)	JHP
			Cortisporin-TC Otic Suspension (with thimerosal and thonzonium bromide)	JHP

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Ointment	Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone Acetate 1%	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate Ophthalmic Ointment	Fougera

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cipro HC 0.2-1% Suspension (ALCON VISION): 10/$135.99 or 30/$382.98

Cortisporin 0.5-0.5-10000 Cream (MONARCH PHARMACEUTICALS): 7/$54.99 or 22/$164.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2008. McEvoy GK, ed. Hydrocortisone. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008: 2884–5..

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

c. Monarch Pharmaceuticals. Pediotic (neomycin and polymyxin B sulfates and hydrocortisone) otic suspension prescribing information. Bristol, TN; 2003 Apr.

d. Falcon Pharmaceuticals. Neomycin and polymyxin B sulfates, and hydrocortisone ophthalmic suspension prescribing information. Fort Worth, TX; Undated.

g. Falcon Pharmaceuticals. Neomycin and polymyxin B sulfates, and hydrocortisone otic suspension prescribing information. Fort Worth, TX; 2007 Jun.

h. Monarch Pharmaceuticals. Cortisporin (neomycin and polymyxin B sulfates and hydrocortisone) otic solution prescribing information. Bristol, TN; 2003 Apr.

i. JHP Pharmaceuticals. Coly-Mycin S (colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate) otic solution prescribing information. Rochester, MI; 2008 Feb.

j. Alcon. Cipro HC (ciprofloxacin hydrochloride and hydrocortisone) otic suspension prescribing information. Fort Worth, TX; Undated.

k. Fougera. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment prescribing information. Melville, NY; 2004 Aug

l. Taro Pharmaceuticals. Hydrocortisone 1% and acetic acid 2% otic solution prescribing information. Hawthorne, NY; 2004 Jun.