Dexamethasone eent

A synthetic fluorinated corticosteroid.a b d

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

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

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.)

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

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

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

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

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

Category C.a c e f g h i

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

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

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

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

• 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