Mitosol

Mitosol is an antimetabolite medicine that interferes with the growth and spread of certain cells in the body.

Mitosol is used during glaucoma surgery.

Mitosol may also be used for purposes not listed in this medication guide.

A healthcare provider will apply Mitosol to your eye(s) during glaucoma surgery.

Glaucoma surgery is usually performed while you are awake. You will be given medicine to numb your eyes and reduce pain or discomfort during your surgery.

If general anesthesia is used for your surgery, you will not be awake during the operation.

Mitosol is a liquid medicine that is applied first to a tray of tiny sponges. The sponges will soak in the mitomycin for at least 60 minutes.

Once the sponges are saturated with mitomycin, your surgeon will place the sponges directly onto your eye.

The sponges will be left in place for 2 minutes and then removed.

After the sponges are removed, your eye will be rinsed thoroughly.

Your doctor may prescribe other eye medications for you to use after surgery. Use all medications as directed. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

You should not be treated with Mitosol if you are pregnant.

You should not be treated with Mitosol if you are allergic to mitomycin.

You should not be treated with Mitosol if you are pregnant, or if you think you may be pregnant. Mitomycin could harm the unborn baby or cause birth defects.

Before you receive Mitosol, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

It is not known whether mitomycin ophthalmic passes into breast milk or if it could harm a nursing baby. You should not breast-feed after being treated with mitomycin. Follow your doctor's instructions about how long after treatment you should wait before you can breast-feed again.

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

Call your doctor at once if you have:

• blurred vision, vision loss;
• tunnel vision, eye pain, seeing halos around lights; or
• eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection).

Common Mitosol side effects may include:

• eye redness; or
• vision changes.

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.

Usual Adult Dose for Glaucoma:

As an adjunct to ab externo glaucoma surgery: 0.2 mg of mitomycin in fully saturated sponges provided with the kit. Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps. Keep the sponges on the treatment area for two (2) minutes,

Because you will receive this medicine in a clinical setting, you are not likely to miss a dose.

Since Mitosol is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

It is not likely that other drugs you take orally or inject will have an effect on mitomycin used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.