Brand Name(s):

• Collyrium Fresh®
• Murine®Plus
• Optigene®3
• Visine®
• A.R.®Eye Drops (as a combination product containing Tetrahydrozoline, Zinc Sulfate)
• Visine®A.C. (as a combination product containing Tetrahydrozoline, Zinc Sulfate)

IMPORTANT WARNING:

[Posted 10/25/2012]ISSUE:FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma have occurred. Ingestion of only a small amount (1 to 2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children.

BACKGROUND:Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach. These products are sold under various brand names, as generics, and as store brands (see List of Products, included in the Drug Safety Communication, at: Web Site).

RECOMMENDATION:Consumers should store these products out of reach of children at all times. If a child accidentally swallows OTC redness-relief eye drops or nasal decongestant spray, call your local poison control center (1-800-222-1222) immediately. Experts are available all day, every day at these centers. For more information visit the FDA website at: Web Siteand Web Site.

WHY is this medicine prescribed?

Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.

HOW should this medicine be used?

Ophthalmic tetrahydrozoline comes as a solution (liquid) to instill in the eyes. The eye drops are usually instilled in the affected eyes three or four times a day as needed. Follow the directions on the package label or your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use tetrahydrozoline exactly as directed. Do not use more or less of it or use it more often than directed by your doctor or written on the package label.

To use the eye drops, follow these steps:

• Wash your hands thoroughly with soap and water.
• Check the dropper tip to make sure that it is not chipped or cracked.
• Avoid touching the dropper tip against your eye or anything else; eye drops and droppers must be kept clean.
• While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
• Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it.
• Brace the remaining fingers of that hand against your face.
• While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
• Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
• Place a finger on the tear duct and apply gentle pressure.
• Wipe any excess liquid from your face with a tissue.
• If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop.
• Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
• Wash your hands to remove any medication.

Are there 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 tetrahydrozoline eye drops,

• tell your doctor and pharmacist if you are allergic to tetrahydrozoline or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially eye medications, medications for high blood pressure, MAO inhibitors [phenelzine (Nardil) and tranylcypromine (Parnate)], and vitamins.
• tell your doctor if you have any eye disease or infection, heart disease, high blood pressure, or an overactive thyroid gland.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using tetrahydrozoline eye drops, call your doctor.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are using tetrahydrozoline eye drops. You may have to stop using tetrahydrozoline eye drops for a short time.
• tell your doctor if you wear soft contact lenses. If the brand of tetrahydrozoline eye drops you are using contains benzalkonium chloride, wait at least 15 minutes after using the medicine to put in soft contact lenses.

What should I do IF I FORGET to take a dose?

Tetrahydrazoline eye drops are usually instilled as needed. However, if your doctor has told you to instill the drops on a regular schedule and you miss a dose, instill 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 instill a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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). If the medication becomes discolored, do not use it; obtain a fresh bottle. 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 tetrahydrozoline eye drops.

If you still have symptoms of eye irritation after using tetrahydrozoline as directed, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2012.