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 ?
Postoperatively, topical moxifloxacin was given for 2 weeks and difluprednate for 6 weeks on a slow taper.
There are no human eye data for five topical corticosteroids: difluprednate (Durezol), fluorometholone (Flarex, Fluor-OP, FML), loteprednol (Alrex, Lotemax), prednisolone (Econopred), and rimexolone (Vexol).
Group B patients were treated with difluprednate 0.
9] After 1973, difluprednate is first steroid to be approved by FDA in 2008.
Difluprednate (difluoroprednisolone butyrate +acetate or DFBA) is a synthetic difluorinated prednisolone derivative.
After instilling difluprednate emulsion is rapidly deacetylated in the aqueous humor to difluoroprednisolone butyrate (DFB).
Earlier prednisolone acetate 1% suspension was gold standard for post cataract surgery patients but now difluprednate, a new potent steroid is available in market with broad spectrum anti-inflammatory activity.
While several steroids have been introduced over the last few decades, difluprednate is the first to be more potent than prednisolone acetate, which has been considered the "gold standard" and indeed has enjoyed a status as the "go-to" steroid for many inflammatory conditions.
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.