Unoprostone Ophthalmic (patient information)

IMPORTANT WARNING:

Unoprostone is no longer available in the U.S. If you are currently taking unoprostone, you should call your doctor to discuss switching to another treatment.

Why is this medication prescribed

Unoprostone is used to treat eye conditions, including glaucoma and ocular hypertension, in which increased pressure can lead to a gradual loss of vision. Unoprostone is used for patients who cannot use other eye medications for their condition or whose eye condition has not responded to another medication. Unoprostone is in a class of medications called docosanoids. It lowers pressure in the eye by increasing the flow of natural eye fluids out of the eye.

How should this medicine be used

Unoprostone comes as an eyedrop to apply to the eye. It is usually applied to the affected eye(s) twice a day. To help you remember to use unoprostone, use it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use unoprostone exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Unoprostone controls glaucoma and ocular hypertension but does not cure them. Continue to use unoprostone even if you feel well. Do not stop using unoprostone without talking to your doctor.

To apply the eyedrops, follow these steps:

• Wash your hands thoroughly with soap and water.
• Use a mirror or have someone else put the drops in your eye.
• Make sure the end of the dropper is not chipped or cracked.
• Avoid touching the dropper against your eye or anything else.
• Hold the dropper tip down at all times to prevent drops from flowing back into the bottle and contaminating the remaining contents.
• Lie down or tilt your head back.
• Holding the bottle between your thumb and index finger, place the dropper as near as possible to your eyelid without touching it.
• Brace the remaining fingers of that hand against your cheek or nose.
• With the index finger of your other hand, pull the lower lid of the eye down to form a pocket.
• Drop the prescribed number of drops into the pocket made by the lower lid and the eye. Placing the drops on the surface of the eyeball can cause stinging.
• Close your eye and press lightly against the lower lid with your finger for 2-3 minutes to keep the medication in the eye. Do not blink.
• Replace and tighten the cap right away. Do not wipe or rinse it off.
• Wipe off any excess liquid from your cheek with a clean tissue. Wash your hands again.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before using unoprostone

• tell your doctor and pharmacist if you are allergic to unoprostone, benzalkonium chloride, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
• if you are using another topical eye medication, apply it at least 5 minutes before or after unoprostone.
• tell your doctor if you have inflammation (swelling) of the eye and if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking unoprostone, call your doctor.
• you should know that unoprostone solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. If you wear contact lenses, remove them before applying unoprostone and put them back in 15 minutes later.
• if you have an eye injury, infection, or surgery while using unoprostone, ask your doctor if you should continue using the same eyedrops container.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Side Effects

Mild side effects

Unoprostone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• eye burning or stinging
• itchy eyes
• dry eyes
• eye tearing

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• abnormal vision
• pink eye
• redness or swelling of the eyelid
• sensitivity to light

Unoprostone may change the color of your eye (to brown) and darken the skin around the eye. It may also cause your eyelashes to grow longer and thicker and darken in color. These changes usually occur slowly, but they may be permanent. If you use unoprostone in only one eye, you should know that there may be a difference between your eyes after taking unoprostone. Call your doctor if you notice these changes.

Unoprostone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What other information should I know

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Rescula®