Difluprednate


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : Ophth Postoperative ocular inflammation As 0.05% emulsion: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times/day, starting 24 hours after surgery, continue for 2 weeks. Then, decrease to bid for 1 week then taper based on response. Anterior uveitis As 0.05% emulsion: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times/day for 14 days, then taper as clinically indicated. Topical/Cutaneous Corticosteroid-responsive dermatoses As 0.05% cream/ointment: Apply once daily or bid to the affected area(s).
Dosage Details
Ophthalmic
Postoperative ocular inflammation
Adult: As 0.05% emulsion: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily, starting 24 hours after surgery, continue for 2 weeks. Then, decrease to bid for 1 week then taper based on response.

Ophthalmic
Anterior uveitis
Adult: As 0.05% emulsion: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily for 14 days, then taper as clinically indicated.
Child: ≥2 years Same as adult dose.

Topical/Cutaneous
Corticosteroid-responsive dermatoses
Adult: As 0.05% cream/ointment: Apply once daily or bid to the affected area(s).
Contraindications
Active viral diseases of the cornea and conjunctiva (e.g. epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial infection and fungal disease of the eye. Bacterial, viral, fungal or parasitic skin infections, ulcerated lesions, acne, rosacea.
Special Precautions
Patients with glaucoma, history of ocular herpes simplex, diseases which may cause thinning of cornea or sclera, acute purulent conditions. Pregnancy.
Adverse Reactions
Significant: Ophthalmic: Reduced visual acuity, posterior subcapsular cataract formation, increased intraocular pressure, corneal perforation, delayed healing, immunosuppression (e.g. increased risk for bacterial, viral and fungal infection), exacerbation of infections. Topical: Cortico-induced and paradoxically cortico-sensitive dermatitis, and cushingoid syndrome (prolonged use), slowing of growth in children.
Eye disorders: Ciliary, conjunctival and limbal hyperaemia; eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, corneal and conjunctival oedema, blepharitis, punctate keratitis, eye inflammation, iritis, blurred vision, eye irritation, uveitis, dry eye, iridocyclitis.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Skin atrophy, stretch marks, secondary ecchymotic purpura, cutaneous fragility, acneiform or pustular eruptions, hypertrichosis, depigmentation, allergic contact dermatoses.
Vascular disorders: Telangiectasia.
Patient Counseling Information
Ophthalmic: Remove contact lenses prior instillation and reinsert after 10 minutes. Topical: Avoid contact with the eyes.
MonitoringParameters
Monitor intraocular pressure for prolonged use (≥10 days). Perform periodic examination of eye lens (prolonged use >28 days).
Action
Description: Difluprednate is a corticosteroid with glucocorticoid activity. It acts by inhibiting the inflammatory responses including oedema, capillary dilation, leukocyte migration, and scar formation. It penetrates cells and induces production of lipocortins, a protein that modulates the activity of prostaglandins and leukotrienes.
Pharmacokinetics:
Metabolism: Metabolised via deacetylation to 9-difluroprednisolone 17-butyrate (DFB).
Chemical Structure

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Storage
Ophthalmic: Store between 15-25°C. Protect from light. Topical cream/ointment: Store below 25°C.
ATC Classification
D07AC19 - difluprednate ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Disclaimer: This information is independently developed by MIMS based on Difluprednate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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