Durezol (difluprednate)

The recommended initial adult dosage of difluprednate for the treatment of postoperative inflammation and pain in patients who have undergone ocular surgery is 1 drop of a 0.05% emulsion in the affected eye(s) 4 times daily, beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period. After 2 weeks of therapy, dosage should be reduced to 1 drop twice daily for 1 week and then gradually tapered according to response.

Difluprednate is applied topically in the conjunctival sac of the affected eye(s) as an ophthalmic emulsion. Care should be taken to avoid contamination of the emulsion container.

Patients should refrain from wearing contact lenses during therapy with difluprednate ophthalmic emulsion unless specifically directed by a clinician.

Difluprednate ophthalmic emulsion may be used in conjunction with other topical ophthalmic drugs such as beta-adrenergic blocking agents, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered 10 minutes apart from difluprednate administration.

No formal drug interaction studies have been performed to date.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Most active viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella (chickenpox)); mycobacterial infection of the eye; and fungal diseases of ocular structures.

Known hypersensitivity to difluprednate, other corticosteroids, or any ingredient in the formulation.

• Fungal keratitis
• Herpes simplex dendritic keratitis
• Herpes zoster keratitis
• Tuberculosis of the eye
• Vaccinia virus keratitis

• Bacterial keratitis

• Ocular hypertension

Adverse ocular effects reported in 5-15% of patients receiving difluprednate include corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Adverse ocular effects reported in 1-5% of patients include reduced visual acuity, punctate keratitis, eye inflammation, and iritis.

Less Frequent

• Ocular hypertension

Rare or Very Rare

• Adrenocortical insufficiency
• Cataracts
• Central serous chorioretinopathy
• Corneal degeneration
• Corneal edema
• Corneal erosion
• Corneal ulcer
• Fungal infection of eye
• Glaucoma
• Globe perforation
• Hypercortisolism
• Hypersensitivity drug reaction
• Keratitis
• Optic nerve damage
• Punctate keratitis
• Reduced visual acuity
• Uveitis
• Visual changes
• Visual field defect

More Frequent

• Blurred vision

Less Frequent

• Headache disorder
• Iritis
• Ocular pain

Rare or Very Rare

• Accommodation disorder
• Allergic dermatitis
• Blepharoptosis
• Calcification of cornea
• Chemosis
• Conjunctival hyperemia
• Conjunctivitis
• Dizziness
• Dysgeusia
• Eye tearing
• Foreign body sensation of eye
• Impaired wound healing
• Mydriasis
• Ocular infection
• Ocular irritation
• Ocular itching
• Ocular redness
• Photophobia
• Urticaria

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Safety and efficacy not established in pediatric patients.

Category C. (See Users Guide)

Systemically administered corticosteroids distribute into milk and may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk; caution if used in nursing women.

No substantial differences in safety and efficacy relative to younger adults.