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Mitosol (Mitomycin) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS

Cell Death

Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or scleral damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death.

Hypotony

The use of mitomycin has been associated with an increased instance of post-operative hypotony.

Cataract Formation

Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category X (see Contraindications, 4.2).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Mitosol®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. It is recommended that women receiving Mitosol® not breast feed because of the potential for serious adverse reactions in nursing infants.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Page last updated: 2012-02-29

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