Dexamethasone Sodium Phosphate eent

Class: Corticosteroids
ATC Class: S01CA01
VA Class: OP350
CAS Number: 50-02-2
Brands: Ciprodex, Maxidex, Maxitrol, TobraDex

Introduction

A synthetic fluorinated corticosteroid.a b d

Uses for Dexamethasone Sodium Phosphate

Ophthalmic Inflammation

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (e.g., allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides).a c d e f g h

Treatment of chronic anterior uveitis.e g h

Treatment of corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.a c d e f g h

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;e f g h used in fixed combination with neomycin and polymyxin B sulfates or tobramycin when such combination therapy is indicated.e f g h If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.d (See Infections under Cautions.)

Otic Inflammation

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the ear canal (e.g., allergic otitis externa).b c i

Bacterial Otic Infections

Used for anti-inflammatory properties in conjunction with ciprofloxacin for treatment of acute otitis externa and in pediatric patients with tympanostomy tubes for acute otitis media.i

Used to reduce edema and inflammation in select cases of purulent and nonpurulent infective otitis externa.c

If a corticosteroid is used alone or in combination with an otic anti-infective, weigh benefits against risks.d (See Infections under Cautions.)

Dexamethasone Sodium Phosphate Dosage and Administration

Administration

Apply topically to the eye or ear.a b c e f g h i

Ophthalmic Administration

Apply topically to the eye as an ophthalmic ointment, solution, or suspension.a b c e f g h

Not for injection.e f g h

Shake suspension well prior to each use.a g

Avoid contamination of preparation container.a b e f

Do not administer solutions or suspensions containing benzalkonium chloride while wearing soft contact lenses.a c g Wait ≥15 minutes after instilling drops before inserting contact lenses.c (See Advice to Patients.)

Otic Administration

Apply topically to the ear as an otic suspension or an ophthalmic solution.b c i

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

May use dexamethasone sodium phosphate ophthalmic solution in the ear.b c

Shake suspension well prior to each use.i

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.i

Clean and dry ear canal prior to administration;b c d pH of otic preparations should be neutral or acidic.b

Lie with the affected ear upward and instill drops.i For pediatric patients with otitis media and tympanostomy tubes, pump the tragus 5 times to ease penetration of drops into the middle ear.i For acute otitis externa, pull outer ear lobe upward and backward to facilitate entry of drug into ear canal.i

Keep affected ear upward for ≥60 seconds following drug administration.i If necessary, repeat procedure for the opposite ear.i

Use otic corticosteroids sparingly to prevent an accumulation of excess debris in the ear canal.b d

Dosage

Commercially available alone or in fixed combination with anti-infectives; available as dexamethasone or dexamethasone sodium phosphate.a c d e f g h i Solution available as dexamethasone sodium phosphate; dosage expressed in terms of dexamethasone phosphate.c

Pediatric Patients

Bacterial Ophthalmic Infections

Duration of therapy depends on the type and severity of the disease and response to therapy.g Do not discontinue prematurely.g

When discontinuing therapy, gradually taper dosing frequency to avoid exacerbation of the disease.b

Dexamethasone 0.1% and Tobramycin 0.3%
Ophthalmic Suspension

Children ≥2 years of age: Initial 24–48 hours, 1 or 2 drop(s) into the conjunctival sac of the affected eye(s) every 2 hours.g Thereafter, 1 or 2 drops every 4–6 hours.g Gradually reduce dosing frequency as infection improves.g

Ophthalmic Ointment

Children ≥2 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.h

Bacterial Otic Infections
Acute Otitis Externa
Otic Suspension (Dexamethasone 0.1% and Ciprofloxacin 0.3%)

Children ≥6 months of age: 4 drops into the affected ear(s) twice daily for 7 days.i

Acute Otitis Media
Otic Suspension (Dexamethasone 0.1% and Ciprofloxacin 0.3%)

Children ≥6 months of age with tympanostomy tubes: 4 drops into the affected ear(s) twice daily for 7 days.i

Adults

Ophthalmic Inflammation and Bacterial Infections

Duration of therapy depends on the type and severity of the disease and response to therapy.g Do not discontinue prematurely.g

When discontinuing therapy, gradually taper dosing frequency to avoid exacerbation of the disease.b

Dexamethasone 0.1%
Ophthalmic Suspension

For mild inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) up to 4–6 times daily.a

For severe inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) every hour.a Taper dosing frequency as inflammation subsides.a

Dexamethasone Sodium Phosphate 0.1%
Ophthalmic Solution

Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every hour during the day and every 2 hours during the night.c When a favorable response is attained, decrease to 1 drop every 4 hours.c May decrease to 1 drop 3 or 4 times daily to control symptoms.c

Dexamethasone 0.1%, Neomycin 0.35%, and Polymyxin B Sulfates 10,000 units
Ophthalmic Suspension

For mild inflammation: 1 or 2 drop(s) into the conjunctival sac of the affected eye(s) up to 4–6 times daily.f

For severe inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) hourly.f As inflammation subsides, gradually reduce dosing frequency to discontinue.f

Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.e

Dexamethasone 0.1% and Tobramycin 0.3%
Ophthalmic Suspension

Initial 24–48 hours, 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2 hours; thereafter, 1 or 2 drops every 4 to 6 hours.g Gradually reduce dosing frequency as infection improves.g

Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.h

Otic Inflammation
Dexamethasone Sodium Phosphate 0.1% Ophthalmic Solution
Otic

Initially, 3 or 4 drops of the ophthalmic solution into the ear canal 2 or 3 times daily.b c May reduce dosing frequency as symptoms improve.b c Gradually taper the drug when it is discontinued.c

Alternatively, a cotton wick saturated with the ophthalmic solution may be packed into the ear canal; keep the wick moist with the ophthalmic solution; remove saturated wick from ear after 12 to 24 hours.b c Repeat as necessary.b c

Duration of treatment may range from a few days to several weeks.b

Bacterial Otic Infections: Acute Otitis Externa
Dexamethasone 0.1% and Ciprofloxacin 0.3%
Otic

4 drops into the affected ear(s) twice daily for 7 days.i

Special Populations

No special population dosage recommendations at this time.a c e f g h i

Cautions for Dexamethasone Sodium Phosphate

Contraindications

  • Known hypersensitivity to dexamethasone or any ingredient in the formulation.a c e f g h i

  • Ophthalmic Preparations
  • Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).a c e f g h

  • Mycobacterial infection (e.g., ocular tuberculosis) of the eye.a c e f g h

  • Fungal disease of ocular structures.a c e f g h

  • Otic Preparations
  • Viral infections of the external ear canal (e.g., herpes simplex).i

  • Perforation of the ear drum.c

  • Fungal diseases of auricular structures.c

Warnings/Precautions

Warnings

Ocular Effects

Risk of glaucoma with possible damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.a c d e f g h Use with caution in patients with glaucoma because IOP may increase.a c d e f g h

If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.a c d e f g h

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.a c d e f g h

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

Infections

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.a c e f g

In acute purulent conditions of the eye or ear, corticosteroids may mask infection or enhance existing infection.a c d e f g h (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.a c e f

General Precautions

Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of 0.1% ointment or 20 mL of 0.1% suspension should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).e f g h

Fungal Infections

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

Corneal Reepithelialization

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.h

Use of Fixed Combination

When used in fixed combination with ciprofloxacin, neomycin and polymyxin B sulfates, or tobramycin, consider the cautions, precautions, and contraindications associated with the concomitant agents.e f g h i

Specific Populations

Pregnancy

Category C.a c e f g h i

Lactation

Not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.a e f g h i

Caution if used in nursing women.a e f g h

Dexamethasone sodium phosphate ophthalmic solution and dexamethasone in fixed combination with ciprofloxacin otic suspension: Manufacturers recommend discontinuing nursing or the drug.c i

Pediatric Use

Safety and efficacy of ophthalmic dexamethasone suspension or dexamethasone sodium phosphate solution not established.a c

Safety and efficacy of ophthalmic dexamethasone in fixed combination with neomycin and polymyxin B sulfates not established.e f

Safety and efficacy of ophthalmic dexamethasone in fixed combination with tobramycin not established in children <2 years of age.g h

Safety and efficacy of otic dexamethasone suspension in fixed combination with ciprofloxacin not established in infants <6 months of age.i

Geriatric Use

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

Common Adverse Effects

Ophthalmic administration: Elevated IOP,a c e f g h posterior subcapsular cataract formation,a c e g h optic nerve damage,a c e f g h delayed wound healing.e f h

Otic administration: Ear discomfort, ear pain, ear pruritus.i

Dexamethasone Sodium Phosphate Pharmacokinetics

Absorption

Bioavailability

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

Distribution

Extent

Systemically absorbed corticosteroids are distributed into milk; not known whether topical corticosteroids could produce detectable levels in human milk.a e f g h i

Stability

Storage

Ophthalmic

Ointment

Neomycin and polymyxin B sulfates and dexamethasone: 2–25°C.e

Tobramycin and dexamethasone: 8–27°C.h

Solution

Dexamethasone sodium phosphate: 15–30°C.c

Suspension

Dexamethasone: Tight, light-resistant containersb at 8–27°C;a store upright.a

Neomycin and polymyxin B sulfates and dexamethasone: 8–27°C.f

Tobramycin and dexamethasone: Upright containers at 8–27°C.g

Otic

Suspension

Ciprofloxacin and dexamethasone: 15–30°C; protect from light.i Do not freeze.i

Actions

  • Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.a c d e f g h

  • Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte and phagocyte migration; in addition, the drugs reduce capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.d

Advice to Patients

  • Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloridea g h and of delaying reinsertion of the lenses for ≥15 minutes after administration.c Importance of not wearing contact lenses if signs or symptoms of an eye infection occur.e

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.a e f i

  • Importance of advising patients not to touch tip of dropper to eye or surrounding tissue.a c f g h i

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

  • Advise patients to warm the ear suspension by holding the bottle in the hands for 1–2 minutes prior to administration.i

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.a c e g h i

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a c e g h i

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

Preparations

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

Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1%

Maxidex (with benzalkonium chloride; viscous)

Alcon

Ciprofloxacin and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Otic

Suspension

Ciprofloxacin 0.3% and Dexamethasone 0.1% per mL

Ciprodex (with benzalkonium chloride)

Alcon

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

Neomycin and Polymyxin B Sulfates and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) and Dexamethasone 0.1% per g*

Maxitrol

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone

Bausch & Lomb, Falcon, Fougera

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) and Dexamethasone 0.1% per mL*

Maxitrol (with benzalkonium chloride; viscous)

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone

Bausch & Lomb, Falcon

Tobramycin and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3% Tobramycin and Dexamethasone 0.1% per g

TobraDex (with chlorobutanol)

Alcon

Suspension

0.3% Tobramycin and Dexamethasone 0.1% per mL

TobraDex (with benzalkonium chloride)

Alcon

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

Dexamethasone Sodium Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.1% (of dexamethasone phosphate)*

Dexamethasone Sodium Phosphate (with benzalkonium chloride)

Falcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Dexamethasone Sodium Phosphate 0.1% Solution (SANDOZ): 5/$27.99 or 10/$48.97

Maxidex 0.1% Suspension (ALCON VISION): 5/$61.36 or 15/$168.44

TobraDex 0.3-0.1% Ointment (ALCON VISION): 4/$143.74 or 7/$287.48

TobraDex 0.3-0.1% Suspension (ALCON VISION): 3/$67.56 or 8/$174.34

TobraDex 0.3-0.1% Suspension (ALCON VISION): 5/$123.18 or 15/$349.92

Tobramycin-Dexamethasone 0.3-0.1% Suspension (SANDOZ): 3/$35.99 or 8/$99.98

Tobramycin-Dexamethasone 0.3-0.1% Suspension (SANDOZ): 5/$69.99 or 15/$179.98

Tobramycin-Dexamethasone 0.3-0.1% Suspension (SANDOZ): 10/$129.98 or 30/$359.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Alcon Laboratories, Inc. Maxidex 0.1% (dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2007 May.

b. AHFS drug information 2008. McEvoy GK, ed. Dexamethasone. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2874-5.

c. Falcon Pharmaceuticals. Dexamethasone sodium phosphate ophthalmic solution, USP prescribing information. Fort Worth, TX; 2007 Jul.

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

e. Alcon Laboratories, Inc. Maxitrol(neomycin and polymyxin B sulfates, and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

f. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates, and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2003 Aug.

g. Alcon Laboratories, Inc. TobraDex (tobramycin and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2006 May.

h. Alcon Laboratories, Inc. TobraDex (tobramycin and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

i. Alcon Laboratories, Inc. Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension) prescribing information. Fort Worth, TX; 2003 Jul.

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