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Durezol

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Durezol

DUREZOL
(difluprednate) Ophthalmic Emulsion

DRUG DESCRIPTION

DUREZOL (difluprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21- trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula:

DUREZOL (difluprednate ophthalmic emulsion) Structural Formula Illustration

Difluprednate has a molecular weight of 508.56, and the empirical formula is C27H34F2O7.

Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, sodium EDTA, 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%.

What are the possible side effects of difluprednate ophthalmic (Durezol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pain behind your eyes, sudden vision changes, severe headache;
  • sudden eye redness, itching, or other irritation;
  • slow healing after your eye surgery;
  • signs of new eye infection, such as swelling, draining, or crusting of your eyes;
  • eye pain, tunnel vision, or seeing halos around lights;...

Read All Potential Side Effects and See Pictures of Durezol »

What are the precautions when taking difluprednate opthalmic emulsion (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...

Read All Potential Precautions of Durezol »

Last reviewed on RxList: 4/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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Durezol - User Reviews

Durezol User Reviews

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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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