Durezol ophthalmic alcon

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No overall differences in safety or effectiveness have been observed between elderly and younger patients. Difluprednate is represented by the following structural formula:. Difluprednate has a molecular weight of Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate 0. An in vivo micronucleus test of difluprednate in mice was also negative. Long-term studies have not been conducted to evaluate the carcinogenic potential of difluprednate.

In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests of difluprednate showed systemic effects, such as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic glands and adrenal gland; and for local effects, thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well known glucocorticosteroid effects.

Most, if not all of these effects were reversible after drug withdrawal. The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade greater than or equal to "2" a cell count of 11 or higher after cataract surgery were assigned to DUREZOL or placebo vehicle following surgery.

One drop of DUREZOL or vehicle was self-instilled either 2 times per day or 4 times per day for 14 days, beginning the day after surgery. The presence of complete clearing a cell count of 0 was assessed 3, 8 and 15 days post surgery using a slit lamp binocular microscope.

In the intent-to-treat analyses of both studies, a significant benefit was seen in the 4 times per day DUREZOL-treated group in ocular inflammation, at Days 8 and 15, and reduction of pain at Days 3, 8, and 15 when compared with placebo.

The consolidated clinical trial results are provided below. The results are found in Table 1 below. Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton. This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

If pain develops, or if redness, itching, or inflammation becomes aggravated, advise patients to consult a physician [see Warnings and Precautions 5. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Approval: It is not approved by the FDA.

Alcon will now take on all marketing, promotion and sales of Durezol. Healio News Ophthalmology Ophthalmic Business. Read next. March 30, Receive an email when new articles are posted on. Please provide your email address to receive an email when new articles are posted on. You've successfully added to your alerts. You will receive an email when new content is published.

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