Durezol

DRUG DESCRIPTION

Durezol (difuprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-infammatory corticosteroid for ophthalmic use. The chemical name is 6?,9-difuoro-11?,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:

DUREZOL™
  (difuprednate) Structural Formula Illustration

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%.

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; difficulty 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 irritation;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
  • signs of new eye infection, such as swelling, draining, or crusting of your...

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 »


Durezol Consumer (continued)

SIDE EFFECTS: Temporary blurred vision may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in a new fungal infection. Do not use this medication for longer than prescribed.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or increased eye pain/swelling/discharge/redness, eye pain/discomfort in bright light, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 and benefits with your doctor.

It is unknown if difluprednate passes into breast milk. Consult your doctor before breast-feeding.


Durezol Patient Information Including Side Effects

Brand Names: Durezol

Generic Name: difluprednate ophthalmic (Pronunciation: DYE floo PRED nate off THAL mik)

  • What is difluprednate ophthalmic (Durezol)?
  • What are the possible side effects of difluprednate ophthalmic (Durezol)?
  • What is the most important information I should know about difluprednate ophthalmic (Durezol)?
  • What should I discuss with my healthcare provider before I receive difluprednate ophthalmic (Durezol)?
  • How should I use difluprednate ophthalmic (Durezol)?
  • What happens if I miss a dose (Durezol)?
  • What happens if I overdose (Durezol)?
  • What should I avoid after I receive difluprednate ophthalmic (Durezol)?
  • What other drugs will affect difluprednate ophthalmic (Durezol)?
  • Where can I get more information?

What is difluprednate ophthalmic (Durezol)?

Difluprednate is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Difluprednate ophthalmic (for the eye) is used to treat eye swelling caused by surgery.

Difluprednate ophthalmic may also be used for other purposes not listed in this medication guide.

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; difficulty 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 irritation;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
  • signs of new eye infection, such as swelling, draining, or crusting of your eyes.

Less serious side effects may include mild burning, stinging, or itching of your eyes.

  • feeling like something is in your eye;
  • eyes being more sensitive to light;
  • eye pain, itching, or redness; or
  • itchy or watery eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about difluprednate ophthalmic (Durezol)?

You should not use this medication if you are allergic to difluprednate, or if you have any type of viral or fungal eye infection, ocular herpes, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using difluprednate ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use difluprednate.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not stop using difluprednate suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 days of treatment with difluprednate ophthalmic.

Do not wear any contact lens that has not been approved by your doctor.

Do not use difluprednate ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using difluprednate before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Related Drug Centers
  • Durezol


Related Drugs Index: