Ocufen

DRUG DESCRIPTION

OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.

Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate.

OCUFEN® (flurbiprofen sodium ) Structural Formula Illustration

Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of OCUFEN® (flurbiprofen sodium ophthalmic solution) ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260-330 mOsm/kg.

What are the possible side effects of flurbiprofen ophthalmic (Ocufen)?

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:

  • eye pain or redness;
  • vision changes; or
  • severe burning, stinging, or itching of your eyes.

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

This is not a complete list of side effects and others may occur....

Read All Potential Side Effects and See Pictures of Ocufen »

What are the precautions when taking flurbiprofen sodium ophthalmic solution (Ocufen)?

Before using flurbiprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), 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: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes, rheumatoid...

Read All Potential Precautions of Ocufen »


Ocufen Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes may occur when you apply this medication. If any of these effects persist or worsen, 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.

Tell your doctor immediately if any of these rare but serious side effects occur: eye pain, decreased vision, bleeding in the eye (increased redness in the eye).

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 flurbiprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), 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: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes, rheumatoid arthritis.

Your vision may be temporarily blurred or unstable after applying eye drops. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed during the first 6 months. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Ocufen Patient Information Including Side Effects

Brand Names: Ocufen

Generic Name: flurbiprofen ophthalmic (Pronunciation: FLUR bi PROE fen)

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

What is flurbiprofen ophthalmic (Ocufen)?

Flurbiprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Flurbiprofen works by reducing hormones that cause inflammation and pain in the body.

Flurbiprofen ophthalmic (for the eye) is used to prevent your pupil from constricting, or narrowing, during eye surgery.

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

What are the possible side effects of flurbiprofen ophthalmic (Ocufen)?

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:

  • eye pain or redness;
  • vision changes; or
  • severe burning, stinging, or itching of your eyes.

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about flurbiprofen ophthalmic (Ocufen)?

You should not use this medication if you are allergic to flurbiprofen.

Before you receive flurbiprofen ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder or take a blood thinner such as warfarin (Coumadin). If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

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

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

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