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DUREZOL™
(difuprednate) Ophthalmic Emulsion 0.05%
Durezol (difuprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-infammatory corticosteroid for ophthalmic use. The chemical name is 6α,9-difuoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difuprednate is represented by the following structural formula:
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Difuprednate has a molecular weight of 508.56, and the empirical formula is C27H34F2O7.
Each mL contains: ACTIVE: difuprednate 0.5 mg (0.05%) INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, purifed water, sodium acetate, sodium EDTA, and sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
Read All Potential Side Effects and See Pictures of Durezol »
Before using difluprednate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or past eye infection (including viral infections such as herpes simplex keratitis), cataracts, glaucoma.
After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks...
Last reviewed on RxList: 6/11/2009
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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