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DUREZOL is a brand name for Difluprednate, supplied as a emulsion. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
DUREZOL (difluprednate) ophthalmic emulsion is contraindicated in patients with: Hypersensitivity to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section.
Hypersensitivity to other corticosteroids. Suspected or confirmed infection of the eye: viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; acute untreated ocular bacterial infection; mycobacterial infection of the eye, and fungal disease of ocular structures.
WARNINGS AND PRECAUTIONS General DUREZOL (difluprednate) ophthalmic emulsion is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. DUREZOL ophthalmic emulsion is not indicated for intraocular administration. Prolonged use of ophthalmic corticosteroids may result in cataract and/or glaucoma formation, thus, intraocular pressure should be monitored closely.
The use of steroids after cataract surgery may delay wound healing. Corticosteroids should not be used in case of an ocular infection (see WARNINGS AND PRECAUTIONS, Ophthalmologic). Difluprednate has not been studied in pregnant or nursing women, but has been found to be teratogenic in animals.
DUREZOL ophthalmic emulsion should not be used in pregnant or nursing women unless the benefits to the mother clearly outweigh the risk to the foetus or the nursing child. (See WARNINGS AND PRECAUTIONS, Special Populations). DUREZOL ophthalmic emulsion should not be instilled while wearing contact lenses (see WARNINGS AND PRECAUTIONS, Ophthalmologic).
Ophthalmologic 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. Intraocular pressure (IOP) should be monitored routinely starting early during treatment with DUREZOL ophthalmic emulsion.
This is especially important in pediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults. DUREZOL ophthalmic emulsion is not approved for use in pediatric patients.
g. diabetes). Corticosteroids should not be used in the presence of glaucoma or ocular hypertension (IOP≥ 24 mm Hg) or history of steroid-induced IOP elevation, unless absolutely necessary and under close ophthalmologic monitoring. Caution should be exercised and duration of treatment with DUREZOL® Product Monograph Page 5 of 42 DUREZOL ophthalmic emulsion should be kept as short as possible (usually up to 14 days, and tapered as determined by the treating ophthalmologist).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cataracts:
Use of corticosteroids may result in posterior subcapsular cataract formation.
Delayed Healing:
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Topical nonsteroidal anti-inflammatory drug (NSAID) medications are also known to slow of delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
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 14 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.
Bacterial Infections:
Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Viral Infections:
The use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal Infections:
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
Fungal culture should be taken when appropriate.
Contact Lenses:
DUREZOLophthalmic emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL ophthalmic emulsion. The preservative in DUREZOL ophthalmic emulsion may be absorbed by soft contact lenses.
Lenses may be reinserted after 10 minutes following administration of DUREZOL ophthalmic emulsion. Carcinogenesis and Mutagenesis There was no evidence of genotoxicity in the relevant in vitro and animal in vivo tests (see TOXICOLOGY, Genotoxicity).
No carcinogenicity studies of difluprednate have been performed. Neurologic Disturbances and suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis can occur with systemic exposure to corticosteroids. However, given the very low systemic exposure to DUREZOL® Product Monograph Page 6 of 42 difluprednate when using DUREZOL ophthalmic emulsion as directed, these effects, although not likely, are possible (see Endocrine and Metabolism, ACTION AND CLINICAL PHARMACOLOGY).
g. ritonavir and cobicistat). In these cases, treatment should not be discontinued abruptly, but progressively tapered. Drug interaction with CYP3A4 inhibitors The concomitant use of CYP3A4 […]