Durezol

DUREZOL^® is a corticosteroid indicated for:

• •The treatment of inflammation and pain associated with ocular surgery. (
  1.1     Ocular Surgery

  DUREZOL is indicated for the treatment of inflammation and pain associated with ocular surgery.
  )
• •The treatment of endogenous anterior uveitis. (
  1.2     Endogenous Anterior Uveitis

  • DUREZOL is indicated for the treatment of endogenous anterior uveitis.
  )

• •For the treatment of inflammation and pain associated with ocular surgery, instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. (
  2.1     Ocular Surgery

  Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.
  )
• •For the treatment of endogenous anterior uveitis instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated. (
  2.2     Endogenous Anterior Uveitis

  Instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.
  )

Ophthalmic emulsion containing 0.05% difluprednate.

There are no available data on DUREZOL use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Systemic exposure to DUREZOL following ocular administration is low

In animal reproductive studies, subcutaneous administration of difluprednate to pregnant rabbits and rats throughout organogenesis produced maternal toxicity, embryo-fetal toxicity and teratogenicity in rabbits and fetotoxicity in rats.

Administration of difluprednate to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

In embryofetal development studies, subcutaneous administration of difluprednate to pregnant rats during the period of organogenesis decreased the placental weight, at doses greater than or equal to 10 mcg/kg/day (approximately 0.48-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.2 mg/day, on a mg/m² basis and assuming 100% absorption of the dose). Decreased weight gain and delayed ossification of the fetus were observed at a dose of 100 mcg/kg/day (approximately 4.8-fold higher than the MRHOD). The no-observed-effect level (NOEL) for teratogenic effects was 10 mcg/kg/day. In rabbits, subcutaneous administration of difluprednate during the period of organogenesis produced maternal toxicity, embryofetal lethality, fetal growth retardation and teratogenicity (cleft palate, cerebral hernia, exencephaly, hypogenesis of the first digit of the forelimbs, club hand, umbilical hernia and others) at 10 mcg/kg/day (approximately 0.97-fold the MRHOD on a mg/m² basis and assuming 100% absorption of the dose). The NOEL was 1 mcg/kg/day.

In a peri- or pre-/postnatal study in rats, subcutaneous administration of difluprednate during late gestation through lactation resulted in no abnormalities in postnatal development, growth and behavior or reproductive potential. The NOEL was greater than or equal to 10 mcg/kg/day (the highest dose tested; approximately 0.48-fold higher than the MRHOD on a mg/m²basis and assuming 100% absorption of the dose).

• •
  Intraocular Pressure (IOP) Increase:
  Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If DUREZOL is used for 10 days or longer, IOP should be monitored. (
  5.1     Intraocular Pressure (IOP) Increase

  Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. If DUREZOL is used for 10 days or longer, IOP should be routinely monitored.
  )
• •
  Cataracts:
  Use of corticosteroids may result in posterior subcapsular cataract formation. (
  5.2     Cataracts

  The use of corticosteroids may result in posterior subcapsular cataract formation.
  )
• •
  Delayed Healing:
  The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. (
  5.3     Delayed Healing

  The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining.
  )
• •
  Corneal and Scleral Melting:
  In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. (
  5.4 Corneal and Scleral Melting

  Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.
  )
• •
  Bacterial Infections:
  Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. (
  5.6     Viral Infections

  Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
  )
• •
  Viral Infections:
  Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). (
  5.7     Fungal Infections

  Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal culture should be taken when appropriate.
  )
• •
  Fungal Infections:
  Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. (
  5.8     Topical Ophthalmic Use

  DUREZOL is not indicated for intraocular administration.
  )