Mytoxid

Each vial contains Mitomycin, USP 10 mg.

Pharmacology: Pharmacodynamics: Mitomycin-C is an antitumour antibiotic that is activated in the tissues to an alkylating agent which disrupts deoxyribonucleic acid (DNA) in cancer cells by forming a complex with DNA and also acts by inhibiting division of cancer cells by interfering with the biosynthesis of DNA.
Pharmacokinetics: In vivo, Mitomycin-C is rapidly cleared from the serum after intravenous administration. The time required to reduce the serum concentration by 50% after a 30 mg bolus injection is 17 minutes. After injection of 30 mg, 20 mg or 10 mg intravenously, the maximal serum concentrations were 2.4 mcg/mL, 1.7 mcg/mL and 0.52 mcg/mL respectively. Clearance is affected primarily by metabolism in the liver, but metabolism occurs in other tissues as well. The rate of clearance is inversely proportional to the maximal serum concentration because, it is thought, of saturation of the degradative pathways. Approximately 10% of a dose of Mitomycin-C Kyowa is excreted unchanged in the urine. Since metabolic pathways are saturated at relatively low doses, the percentage dose excreted in the urine increases with increasing dose. In children, the excretion of intravenously administered Mitomycin-C Kyowa is similar to that in adults.

Mitomycin is used to improve subjective and objective symptoms in a wide range of neoplastic conditions including chronic lymphatic leukemia, chronic myelocytic leukemia, gastric cancer, colonic and rectal cancer, pulmonary cancer, pancreatic cancer, hepatocarcinoma, uterocervical cancer, mastocarcinoma, tumor of the head and neck, bladder tumor.

Intermittent Administration: 4-6 mg of Mitomycin daily, once or twice a week intravenously.
Continuous Administration: 2 mg of Mitomycin, daily intravenously.
Massive Intermittent Administration: 10-30 mg daily at 1- to 3-week intervals or more intravenously.
Concomitant Administration with Other Antineoplastics: 2-4 mg of Mitomycin is given concomitantly with other antineoplastic agents daily, every one to two weeks.
For administration to specific cases, 2-10 mg of Mitomycin can be given also into the pleural and peritoneal cavities and by the arterial route.
Bladder Tumors: In the prevention of recurrent bladder tumors, the usual dose is the equivalent of 4-10 mg of Mitomycin instilled into the bladder once a day or every two days.
In the treatment of bladder tumors, the usual dose is the equivalent of 10-40 mg of Mitomycin instilled into the bladder once a day.
In I.V injection, maximum dosage a day is 30 mg.
Dosage of Mitomycin must be based on age and condition of the patient.
For reconstitution, the contents of the 10 mg vial should be dissolved in 20 mL water for injection. It is stable at room temperature for 7 days and 14 days when refrigerated (2-8°C) or as prescribed by the physician.

Fever, nausea, vomiting, and bone marrow suppression may occur. If it occurs, appropriate therapy should be administered.

Patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past.
Patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

In patients with hepatic failure, renal impairment, bone marrow suppression.

The drug should be used under constant supervision from physicians experienced in cancer chemotherapy, and it should be administered only to hospitalized patients who receive frequent determinations of hematopoietic, renal, and pulmonary function.
Patients receiving Mitomycin should be informed of the drug's potential toxicity, particularly bone marrow suppression; deaths have been reported due to septicemia as a result of leukopenia due to the drug.
Patients receiving Mitomycin should be observed for evidence of renal toxicity. Mitomycin should not be given to patients with a serum creatinine greater than 1.7 mg%.
Pharmaceutical Precautions: Cellulitis at the injection site has occurred and is occasionally severe.
Care should be taken to avoid extravasations of the drug.
When reconstituted solution is added to infusion fluids, especially when these contain dextrose, the resulting solution should be used immediately.
Use in Pregnancy & Lactation: Mitomycin has produced teratogenic effects in animals. Safe use of Mitomycin in pregnant women has not been established.
Safe use of mitomycin in lactation has not been established.
Use in Children: Should be cautioned for the appearance of adverse effects.

Mitomycin has produced teratogenic effects in animals. Safe use of Mitomycin in pregnant women has not been established.
Safe use of mitomycin in lactation has not been established.

Hematologic: Thrombocytopenia, leukopenia, hemorrhage, anemia.
Hepatic: Rarely, hepatic failure may occur.
Renal: Renal failure may occur as a component of a hemolytic uremic syndrome in patients receiving Mitomycin.
Hypertension, edema, hematuria, albuminuria has occurred in some patients receiving Mitomycin. Patients should be monitored regularly.
Gastrointestinal: Anorexia, nausea, vomiting, stomatitis, gastritis, diarrhea.
Hypersensitivity: Rashes are rarely reported.
Urologic: In the case of instillation into the bladder, necrotic cystitis, urethrostenosis may occur.
Respiratory: Rarely pneumonitis.
Cardiac: Congestive heart failure has rarely been reported.
Others: Rarely headache, blurred vision, confusion, edema, drowsiness, syncope, fatigue, hematemesis, and pain.

Concomitant of combination with other malignant antitumor agent or irradiation, bone marrow suppression could be occur, therefore state of patients should be monitored regularly and be cautioned with the reduction of dose.
Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids (i.e. vincristine sulfate, vinblastine sulfate and vindesine sulfate) in patients who had previously or simultaneously received mitomycin.
In case of combination with phenytoin, hepatic metabolism of cytotoxic substance may increase concomitant to use of busulfan, ifosfamide, etoposide and teniposide.
Combination with yellow fever vaccine could cause generalized or fetal disease, therefore combination with the drug should be avoided.
In case of combination with doxorubicin, cardiotoxicity may increase because of formation of free radical.
Possibility of lung damage has been reported due to uratic nitrogen, and doxorubicin.
Barbiturate may increase the effect of the drug.

Store at a temperature not exceeding 30°C. Protect from light.

Cytotoxic Chemotherapy

L01DC03 - mitomycin ; Belongs to the class of other cytotoxic antibiotics. Used in the treatment of cancer.

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