PDR Drug Summaries are concise point-of-care prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in. Medscape – Indication-specific dosing for Durezol, (difluprednate), frequency- based contraindications, pregnancy & lactation schedules, and cost information. Medscape prescription drug monographs are based on FDA- approved labeling. USP) tablets. Full Prescribing Information, including Boxed WARNING Durezol. (difluprednate ophthalmic emulsion) %. Full Prescribing Information. E.

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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Ophthalmic corticosteroid Used for postoperative ocular pain and inflammation and endogenous prescrubing uveitis Safety and efficacy comparable to betamethasone 0.

At the end of the third week, taper dose based on response. In a double-blind trial in pediatric patients aged 0 to 3 years who underwent cataract surgery, a similar safety profile was observed in patients who received difluprednate 0.

Instill 1 drop into the conjunctival sac of the affected eye s 4 times daily for 14 days followed by tapering as clinically indicated. Infogmation should be taken not to discontinue therapy prematurely. If ocular signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. Intraocular pressure should be monitored after 10 days of therapy, and an ophthalmologic exam should occur after 14 days of therapy. Difluprednate is administered topically to the eye.

Shake well before use.

Do not to touch the tip of the dropper to the eye, fingertips, or other surface. Instruct patient on proper instillation of eye solution. When using difluprednate, the patient should not wear contact lenses. Difluprednate is contraindicated in individuals with glycerin hypersensitivity, hypersensitivity to difluprednate, corticosteroid hypersensitivity, polysorbate 80 hypersensitivity, or any of the other product ingredients boric acid, castor oil, polysorbate 80, sodium acetate, sodium EDTA, sodium hydroxide.

The use duresol ocular steroids may prolong the course and exacerbate the severity of ocular infections. Ophthalmic steroid use may result in delayed or impaired wound healing of the eye or cornea, or mask the signs of ocular infection. Difluprednate, as with other ophthalmic corticosteroids, is contraindicated in most cases of viral infection of the cornea and conjunctiva, such as epithelial herpes simplex keratitis dendritic keratitisvaccinia, and varicella.


Difluprednate is also contraindicated in any mycobacterial infection of the eye or fungal infection of ocular structures. Fungal druezol of the cornea may develop with long-term ocular application of steroids. Fungal invasion should be evaluated in any persistent corneal ulceration where corticosteroid treatment has been used.

Fungal cultures should be taken when appropriate. Corticosteroid therapy can also exacerbate purulent bacterial infections of the eye. Increased intraocular pressure intraocular hypertension durezo, most likely to occur in patients receiving prolonged ophthalmic corticosteroids and in patients with glaucoma.

Intraocular pressure elevations are usually greater in eyes with open-angle glaucoma. If difluprednate is used for 10 days or longer, intraocular pressure should be monitored.

Long-term ocular administration of corticosteroids, like difluprednate, for several years has been associated with the formation of posterior subcapsular PSC cataracts. Patients with diabetes mellitus appear to be more susceptible to developing PSC cataracts during ocular steroid use.

Patients should be monitored for the development of lens opacities during long-term corticosteroid therapy. In patients with corneal or scleral thinning, administration of topical ophthalmic corticosteroids has caused perforations.

Difluprednate should be used with caution in patients with a corneal abrasion. Patients who wear contact lenses should be aware that Durezol difluprednate contains the preservative sorbic acid. As with all ophthalmic preparations containing a preservative, patients should be advised not to wear contact lenses when using Durezol.

One Therapy for Many Eyes

Difluprednate is classified as pregnancy category C. Animal studies using subcutaneous doses produced teratogenic and embryotoxic effects. Other corticosteroids have been shown to cause fetal resorptions and malformations. The systemic absorption of difluprednate following ophthalmic administration is minimal; however, informatiln to the manufacturer, because there have been no adequate studies conducted into dkrezol safe use of difluprednate in pregnant women, it should only be used when the potential benefits to the mother outweigh possible risks to the fetus.

Difluprednate has not been studied during breast feeding. While the American Academy of Pediatrics does not comment on the use of ophthalmic difluprednate during breast-feeding, it does consider some systemic corticosteroids prednisone and prednisolone to be usually compatible with breast-feeding.

It is not known whether ophthalmic difluprednate results in sufficient systemic absorption to produce detectable quantities in breast milk; but pharmacokinetic studies indicate that systemic absorption after ophthalmic administration of difluprednate is limited and therefore unlikely that a significant amount of drug would be excreted into breast-milk. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over inforamtion tear duct by the corner of the eye for 1 minute after ophthalmic administration.

  BS 2782-5 PDF

Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated infirmation.

If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

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Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, durezok dilation, leukocyte migration, capillary proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the exact mechanism of action for ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.

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Lipocortins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid. Arachidonic acid is ingormation from membrane phospholipids by phospholipase A2. Corticosteroids can increase intraocular pressure. The mechanism by which ophthalmic corticosteroids increase intraocular pressure is not clear.

Corticosteroids are associated with the presence of extracellular glycosaminoglycans in ocular trabecular cells, which have been hypothesized to increase the resistance of aqueous outflow. Difluprednate undergoes deacetylation in vivo to the active metabolite 6 alpha, 9-difluoroprednisolone butyrate DFB. Limited systemic absorption of difluprednate occurs following daily administration.

Durezol (difluprednate) dose, indications, adverse effects, interactions from

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For the treatment of inforamtion anterior uveitis. Fungal infection, herpes simplex keratitis dendritic keratitismycobacterial infection, ocular infection, varicella, viral infection. Glaucoma, increased intraocular pressure, open-angle glaucoma.