Mitomycin Ophthalmic

What Is Mitomycin Ophthalmic and How Does It Work?

Mitomycin ophthalmic is used as an adjunct to ab externo glaucoma surgery.

Mitomycin ophthalmic is available under the following different brand names: Mitosol.

Dosages of Mitomycin Ophthalmic:

Dosage Forms and Strengths

Ophthalmic Solution

Dosage Considerations – Should be Given as Follows:

Glaucoma Surgery

Indicated for as an adjunct to ab externo glaucoma surgery
Sponges provided within the kit should be fully saturated with the entire reconstituted contents
A treatment area approximating 10mm x 6mm +/- 2mm should be treated with mitomycin ophthalmic
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 2 minutes, and then remove and copiously irrigate surgical site

Administration

Intended for topical application to the surgical site of glaucoma filtration surgery
Not for intraocular administration; if intraocular administration occurs, cell death may lead to corneal infarction, retinal infarction, and ciliary body atrophy

Reconstitution

Each vial contains a lyophilized mixture of mitomycin 0.2 mg and mannitol 0.4 mg
To reconstitute, add 1 mL of sterile water for injection, then shake to dissolve
If the product does not dissolve immediately, allow it to stand at room temperature until the product dissolves into a solution
Following reconstitution, the resulting solution has a pH of 5.0-8.0
Preparing sponges: See full prescribing information

Stability

Unreconstituted vials: Store at controlled room temperature (i.e., 20-25°C [68-77°F]); avoid excessive heat and protect from light
Reconstituted vials: When reconstituted to a concentration of 0.2 mg/mL, stable for 1 hour at room temperature
Handling and disposal
Procedures for proper handling and disposal of anticancer drugs should be followed
Appropriate containment and disposal devices are included in each kit
Safety and efficacy not established in pediatric patients