difluprednate


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difluprednate (ophthalmic)

(dye-floo-pred-nate) ,

Durezol

(trade name)

Classification

Therapeutic: ocular agents
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Treatment of inflammation and pain associated with ocular surgery.

Action

Decreases inflammation.

Therapeutic effects

Decreased pain and inflammation following ocular surgery.

Pharmacokinetics

Absorption: Limited systemic absorption.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
Ophthunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Active viral, mycobacterial or fungal infection of eyes and surrounding structures.
Use Cautiously in: Obstetric: Use in pregnancy only if potential benefit justifies potential risk to the fetus; Lactation: Use cautiously during lactation; Pediatric: Safety and effectiveness in children have not been established.

Adverse Reactions/Side Effects

Ear, Eye, Nose, Throat

  • ↑ intraocular pressure
  • blepharitis
  • cataracts
  • conjunctival hyperemia
  • corneal edema
  • delayed healing
  • eye pain
  • infections
  • iritis
  • photophobia

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Ophthalmic (Adults) 1 drop four times daily, starting 24 hr after surgery for 2 wk, then twice daily for one week, then further tapered based on response.

Availability

Ophthamic emulsion: 0.05% in 5 mL bottle

Nursing implications

Nursing assessment

  • Assess affected eye for pain and swelling during therapy.
  • Monitor intraocular pressure of difluprednate is used more than 10 days.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Ophthalmic: Instill 1 drop into conjunctival sac of affected eye 4 times/day beginning 24 hrs after surgery and continuing throughout first 2 wks of postoperative period, followed by twice daily for a wk, then base dose on patient response.

Patient/Family Teaching

  • Instruct patient in correct technique and frequency for instillation of eye drops (see ).
  • Instruct patient to avoid wearing contact lenses during therapy.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Advise patient to notify health care professional if redness, itching or inflammation develops or becomes aggravated.

Evaluation/Desired Outcomes

  • Decrease in eye pain and inflammation following ocular surgery.
References in periodicals archive ?
Therapeutic use: Difluprednate (20, 21) is a topical cortico-steroid indicated to decrease inflammation and pain related to ocular surgery.
Sirion's pipeline includes four late-stage opportunities: ganciclovir, a topical antiviral for herpetic keratitis which is awaiting an NDA filing; difluprednate, a potent topical steroid in Phase III development for post-operative inflammation and uveitis; cyclosporine, a topical immunomodulator in Phase III testing for dry eye and fenretinide, a first-in-class oral vitamin A binding protein antagonist in Phase II development for geographic atrophy associated with dry AMD.
Difluprednate, the active ingredient in Durezol, is a difluorinated prednisolone derivative that has potent anti-inflammatory activity.
Prior to US approval, the efficacy and safety of difluprednate dosed four times a day in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan, including two studies in anterior uveitis and one in refractory uveitis.
approval, the efficacy and safety of difluprednate in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan.
Sirion's pipeline includes four compounds: difluprednate, a topical steroid for post-operative inflammation and uveitis; ganciclovir, a topical antiviral for herpetic keratitis; cyclosporine, a topical immunomodulator for dry eye; and fenretinide, a first-in-class oral vitamin A binding protein antagonist for geographic atrophy associated with dry AMD.
Sirion's pipeline includes four compounds: difluprednate, a topical steroid for post- operative inflammation and uveitis; ganciclovir, a topical antiviral for herpetic keratitis; cyclosporine, a topical immunomodulator for dry eye; and fenretinide, a first-in-class oral vitamin A binding protein antagonist for geographic atrophy associated with dry AMD.
a privately held ophthalmic-focused biopharmaceutical company, announced positive preliminary results from its Phase III difluprednate (ST-601) program, which evaluated the steroid's potential to rapidly resolve inflammation in the eye following ocular surgery.
Sirion's pipeline includes four late-stage opportunities: ganciclovir, a topical antiviral for herpetic keratitis which is awaiting an NDA filing in early 2008; difluprednate, a potent topical steroid in Phase III development for post-operative inflammation and uveitis; cyclosporine, a topical immunomodulator in Phase III testing for dry eye and fenretinide, a first-in-class oral vitamin A binding protein antagonist in Phase II development for geographic atrophy associated with dry AMD.
rights to develop and market a topical ophthalmic emulsion containing the steroid compound difluprednate for the treatment of inflammatory eye diseases and conditions.
Initiating patient enrollment in our phase III clinical trials for difluprednate is another important milestone for Sirion," said Barry Butler, President and Chief Executive Officer of Sirion Therapeutics, Inc.