Hydrocortisone Acetate eent

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

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

Absorption

Bioavailability

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

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

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.

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

* 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
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	Monarch
			Neomycin Sulfate, Polymyxin B Sulfate, and Hydrocortisone Otic Solution
			Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution
	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
			Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution
			PediOtic Suspension	Monarch

Hydrocortisone Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Otic	Suspension	1% with Ciprofloxacin Hydrochloride 0.2% (of ciprofloxacin)	Cipro HC Otic Drops	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	JHP
			Cortisporin-TC Otic Suspension	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