Ocufen

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.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

• Eye Care and Eye Disorder

© Ocufen Patient Information is supplied by Cerner Multum, Inc. and Ocufen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Ocufen is part of the drug class:

• Antiinflammatory agents, non steroids

Before taking Ocufen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Ocufen or to any of its ingredients, asprin, or any other NSAIDs
• have any bleeding disorders
• have any immune system diseases
• have or have recently had an eye infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

To make sure you can safely use flurbiprofen ophthalmic, tell your doctor if you have a bleeding or blood-clotting disorder.

FDA pregnancy category C. It is not known whether flurbiprofen ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether flurbiprofen ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Do not use other eye medications during treatment with flurbiprofen ophthalmic unless your doctor tells you to.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, Ocufen® ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.

Applies to flurbiprofen ophthalmic: ophthalmic solution

General

The most commonly reported side effects were eye irritation, eye pain, and hyphema.[Ref]

Ocular

Very common (10% or more): Eye irritation, eye pain, hyphema
Frequency not reported: Transient burning/stinging upon instillation, fibrosis, miosis, increased bleeding tendency of ocular tissues in conjunction with ocular surgery
Postmarketing reports: Eye hemorrhage, mydriasis (prolonged mydriasis), ocular hyperemia[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions[Ref]

Some side effects of Ocufen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.