MitoMYcin (Ophthalmic)

Name: MitoMYcin (Ophthalmic)

What Is Mitomycin Ophthalmic?

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

Mitomycin ophthalmic (for the eyes) is used during glaucoma surgery.

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

You should not be treated with this medicine if you are pregnant.

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

You should not be treated with mitomycin ophthalmic 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 mitomycin ophthalmic, 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 this medicine. Follow your doctor's instructions about how long after treatment you should wait before you can breast-feed again.

Mitomycin Ophthalmic Side Effects

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about mitoMYcin, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about mitoMYcin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using mitoMYcin.

Review Date: October 4, 2017

Pharmacologic Category

  • Antineoplastic Agent, Antibiotic
  • Ophthalmic Agent, Miscellaneous

Dosing Geriatric

Refer to adult dosing.

Reconstitution

Kit should only be opened and reconstituted by sterile surgical scrub technician. To reconstitute, add 1 mL of SWFI; shake/swirl to dissolve (detailed instructions are available in the kit). If powder does not dissolve immediately, allow to stand at room temperature until it dissolves completely into solution.

Storage

Store at 20°C to 25°C (68°F to 77°F). Avoid excessive heat. Protect from light.

Reconstituted solution is stable for 1 hour at room temperature.

Pregnancy Risk Factor X Pregnancy Considerations

Use is contraindicated in pregnant women or women who may become pregnant during therapy. Teratogenic effects have been observed in animal reproduction studies following parenteral administration. May cause fetal harm if administered during pregnancy.

Mitomycin ophthalmic side effects

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Mitomycin ophthalmic dosing information

Usual Adult Dose for Glaucoma:

-Usual dose: 0.2 mg applied with saturated sponges (provided in the kit) equally to the treatment area with surgical forceps
-Duration of therapy: 2 minutes

Comments:
-This drug should not be administered intraocularly.
-After 2 minutes, sponges and preparation materials should be discarded in a chemotherapy waste bag.

Use: As an adjunct to ab externo glaucoma surgery

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