Pronunciation:

mye-toe-MYE-sin

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Uses of This Medicine:

Mitomycin topical eye solution is used to help in glaucoma surgery. This medicine belongs to the group of medicines called antimetabolites.

This medicine is to be applied only by or under the direct supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of mitomycin topical eye solution in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mitomycin topical eye solution in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hexaminolevulinate

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or
• Lens implant (eg, phakic intraocular lens)—Use with caution. May increase risk for serious side effects.

Proper Use of This Medicine:

A doctor or other trained health professional will apply this medicine to your eyes using sponges during glaucoma filtration surgery.

Precautions While Using This Medicine:

Your eye doctor will check your eyes closely to make sure it is working properly and is not causing unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may increase the risk of cataracts. Tell your doctor right away if you have blindness, blurred vision, or decreased vision.

Tell your doctor right away if you have decreased vision or any changes in your vision. These could be symptoms of hypotony (decreased tension or pressure in the eye).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Blindness

blurred vision

decreased vision or any change in vision

dislocated eye implants

eye pain, redness, irritation, or inflammation

flashes of light or floaters in vision

headache

red or bloodshot eye

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

tearing of the eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Opening of the surgical wound

raising of the upper eyelid

sensitivity of the eyes to light

throbbing pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.