Zirgan is an antiviral medicine. It slows the growth and spread of the cytomegalovirus (CMV).

Zirgan ophthalmic gel is used to treat eye ulcers caused by the herpes simplex virus in adults and children at least 2 years old.

Zirgan is not a cure for CMV or herpes. This medication will not treat symptoms of these infections in any other part of the body.

You should not use Zirgan if you are allergic to ganciclovir or acyclovir (Zovirax).

Zirgan is not a cure for cytomegalovirus or herpes. This medication will not treat symptoms of these infections in any other part of the body.

To make sure you can safely use Zirgan, tell your doctor if you have low levels of platelets in your blood (easy bruising or bleeding), or an infection in any part of your body (other than your eyes).

Do not wear contact lenses while you are using Zirgan. You should not wear contact lenses at any time you have an active eye ulcer or infection.

Use Zirgan ophthalmic gel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Zirgan ophthalmic gel is usually applied about every 3 hours while you are awake (up to 5 times per day). Once the eye ulcer heals, the gel is usually applied 3 times per day for 7 days. Follow your doctor's dosing instructions very carefully.

Wash your hands before using eye medication.

To apply Zirgan:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop into this pocket, the close your eyes for 1 or 2 minutes.

• Use only the number of drops your doctor has prescribed.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

Do not allow the tip of the dropper to touch any surface, including your 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.

Zirgan does not cure herpes or CMV. Your disease may continue to progress even after you are treated with this medication. Your doctor will need to check your progress on a regular basis, and you will need routine eye exams.

Ask your doctor before using contact lenses. Wearing them may increase your risk of repeated herpes infections or eye ulcers.

Store Zirgan at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Herpes Simplex Dendritic Keratitis:

Instill 1 drop in the affected eye 5 times a day (about every 3 hours while awake) until corneal ulcer heals, and then 1 drop 3 times a day for 7 days.

Use: For the treatment of acute herpetic keratitis (dendritic ulcers)

Usual Pediatric Dose for Herpes Simplex Dendritic Keratitis:

2 years or older: Instill 1 drop in the affected eye 5 times a day (about every 3 hours while awake) until corneal ulcer heals, and then 1 drop 3 times a day for 7 days.

Use: For the treatment of acute herpetic keratitis (dendritic ulcers)

You should not use Zirgan if you are allergic to ganciclovir or acyclovir (Zovirax).

To make sure you can safely use Zirgan, tell your doctor if you have any of these other conditions:

• an infection in any part of your body (other than your eyes); or

• low levels of platelets in your blood (easy bruising or bleeding).

It is not known whether Zirgan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ganciclovir can decrease sperm count and may affect a man's fertility (ability to have children). It is not known whether ganciclovir passes into breast milk or if it could harm a nursing baby. Do not use Zirgan without telling your doctor if you are breast-feeding a baby. Zirgan gel should not be given to a child younger than 2 years old.

Tell your doctor if you are pregnant or breastfeeding.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Zirgan may cause blurred vision. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid touching your eyes. Wash your hands frequently to prevent the spread of infection.

Do not use other eye medications unless your doctor tells you to.

Do not wear contact lenses while you are using Zirgan. You should not wear contact lenses at any time you have an active eye ulcer or infection.

Get emergency medical help if you have signs of an allergic reaction to Zirgan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision changes;

• eye pain, burning, redness, or watering;

• a gritty feeling, like something is in your eye; or

• watery eyes, and your eyes may be more sensitive to light.

Common Zirgan side effects may include:

• blurred vision;

• eye irritation; or

• redness, watering, sensitivity to light.

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.