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 ?
Durezol Compared to Pred Forte(R) in the Treatment of Endogenous Anterior Uveitis
Dose Uniformity of Prednisolone Acetate Ophthalmic Suspensions Compared to Durezol (difluprednate ophthalmic emulsion) 0.
Promotional activity for Bausch & Lomb's Retisert and Alcon's Durezol and Triesence is also assessed.
an ophthalmic biopharmaceutical company that brought Durezol and Zirgan to market.
The current market is served in the main by three approved products namely Alcon Laboratories's Durezol, Allergan's Ozurdex, and Bausch & Lomb's Retisert.
Medications at that time included Xibron drops, a NSAID to reduce swelling, Durezol drops, a topical corticosteroid, Cornbigan drops, and oral Voltaren.
The Ophthalmic Pharmaceuticals franchise benefited from growth of the Systane (dry eye), Nevanac (inflammation) and Durezol (inflammation) brands, as well as strong growth in combination glaucoma brands DuoTrav and Azarga.
The primary endpoint was the difference from baseline in anterior chamber (AC) cell grades between the Durezol and Pred Forte groups.
In one trial of 136 patients with anterior uveitis and panuveitis, those treated with Durezol QID had a significantly greater improvement on Day 7 compared to those treated with betamethasone ophthalmic solution, 0.
Durezol was approved by the US Food and Drug Administration in June 2008 for the treatment of inflammation and pain associated with ocular surgery.
Results from Phase 3b Studies with Durezol Dosed Prior to Surgery
Sirion Therapeutics plans to make Durezol commercially available in late 2008.