Ganciclovir Ophthalmic

The Vitrasert implant is surgically placed into the eye. The implant will slowly release ganciclovir into the affected eye over a period of 5 to 8 months.

Use Zirgan gel exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Zirgan is usually applied 5 times each day until your eye ulcer heals. Then the gel is applied 3 times per day for 7 days. Follow your doctor's instructions.

Wash your hands before using the eye drops.

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, then close your eye.
• 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.

Ganciclovir 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.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Since the Vitrasert implant is surgically put into place, you will not be on a dosing schedule for this medication. The implant may be removed and replaced after 5 to 8 months.

>10%

Zirgan

• Blurred vision (60%)
• Eye irritation (20%)

Vitrasert

• Visual acuity loss (10-20%)
• Retinal detachment (10-20%)
• Vitreous hemorrhage (10-20%)

1-10%

Zirgan

• Punctate keratitis (5%)
• Conjunctival hyperemia (5%)

Frequency Not Defined

Vitrasert

• Uveitis
• Hyphema
• Macular degeneration
• IOP spike

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ganciclovir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ganciclovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ganciclovir ophthalmic in children. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ganciclovir ophthalmic in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Your doctor will tell you how much of ganciclovir to use and how often. Do not use more medicine or use it more often than your doctor tells you to. ganciclovir is not for long-term use.

To use the eye drops:

• First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the eye). Always keep the container tightly closed.

Dosing

The dose of ganciclovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ganciclovir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For treatment of acute herpetic keratitis:
    • Adults and children 2 years of age and older—Put one drop in the affected eye five times a day, (every three hours) until the symptoms improve. Then, one drop three times a day for 7 days.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ganciclovir, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

>10%: Ophthalmic: Blurred vision (60%), eye irritation (20%)

1% to 10%: Ophthalmic: Punctate keratitis (5%), conjunctival hyperemia (5%)

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Since the Vitrasert implant is surgically put into place, you will not be on a dosing schedule for this medication. The implant may be removed and replaced after 5 to 8 months.

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)

It is not likely that other drugs you take orally or inject will have an effect on ganciclovir used in the eyes. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.