Mitomycin2 mg/vial

This is indicated in Diabetic foot infections; Chronic lymphatic leukaemia; Chronic myelogenous leukaemia; Gastric, Colorectal, Lung, Pancreatic, Cervix, Endometrium, Breast, Bladder, Head & neck carcinoma.

Cytotoxic Chemotherapy

Mitomycin is an antineoplastic antibiotic which is enzymatically reduced to its active metabolite within susceptible cells. The active metabolite appears to cause cross-linking of DNA (primarily with guanine and cytosine pairs). It is also active against gm+ve bacteria and some viruses.

Solid tumours Suggested regimen: Initial: 10-20 mg/m2; may repeat 6-8 wkly depending on blood count. Do not repeat if leucocyte and platelet counts are below acceptable levels. Do not re-administer if the nadir of the leucocyte count is <2,000 cells/mm3Intravesical Superficial bladder tumours: Instill 10-40 mg 1 -3 times/wk for a total of 20 dosesPrevention of recurrent bladder tumours: Instill 20 mg 2 wkly or 40 mg 1-3-mthly.

Solid tumours Suggested regimen: Initial: 10-20 mg/m2; may repeat 6-8 wkly depending on blood count. Do not repeat if leucocyte and platelet counts are below acceptable levels. Do not re-administer if the nadir of the leucocyte count is <2,000 cells/mm3Intravesical Superficial bladder tumours: Instill 10-40 mg 1 -3 times/wk for a total of 20 dosesPrevention of recurrent bladder tumours: Instill 20 mg 2 wkly or 40 mg 1-3-mthly.

Increased incidence of cardiotoxicity with doxorubicin.

Hypersensitivity. Patient with platelet counts <100,000/mm3, leukocyte counts <4,000/mm3 or serum creatinine concentration >1.7 mg/dL. Patient with substantial prolongation of prothrombin time or bleeding time, coagulation disorders, increased bleeding tendency. Pregnancy and lactation.

Hemolytic uremic syndrome (<15%), Myelosuppression (64%), Nausea/ vomiting (14%), Fever (14%), Stomatitis (4%), Increased serum creatinine (2%), Mucous membrane toxicity (4%) , Fatigue, Pulmonary toxicity, Dyspnea, Cystitis, Interstitial fibrosis, Nephrotoxicity, Amenorrhea, Alopecia, Myelosuppression, haemolytic-uraemic syndrome.

Pregnancy category- D

Repeated haematologic studies are necessary during treatment and for at least 7 wk after discontinuation of the drug. Discontinue use when the leucocyte count decreases to <4000/mm3 or the platelet count decreases to <150,000/mm3 or if a progressive decline in either occurs. Monitor patient for signs of renal or pulmonary toxicity.

Powder for injection: Store between 15-30°C. Protect from light. Reconstituted solution: Stable for 1 wk when stored between 15-25°C and 2 wk when stored between 2-8°C.

Intravenous: Reconstitute by adding 10, 40 or 80 mL of sterile water for inj to a vial labeled as containing 5, 20, or 40 mg respectively, to provide a soln containing approx 0.5 mg/mL. The vial should be shaken to enhance dissolution. If the powd for inj does not dissolve immediately, allow the vial to stand at room temp until complete dissolution occurs.

Cytotoxic Chemotherapy

Mitomycin is an antineoplastic antibiotic which is enzymatically reduced to its active metabolite within susceptible cells. The active metabolite appears to cause cross-linking of DNA (primarily with guanine and cytosine pairs). It is also active against gm+ve bacteria and some viruses.

Pregnancy category- D