Mitomycin Injection USP 2 & 10 mg

Mitomycin was first investigated as an antibiotic in Japan. It was then found to be active as an antineoplastic agent. It selectively inhibits the synthesis of deoxyribonucleic acid (DNA). The exact point of mitomycin attachment to DNA remains unknown. There is a correlation between the guanine and cytosine content of DNA and the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.Mitomycin Injection USP 2 & 10 mg  is indicated as topical therapy for superficial (no invasion beyond the lamina propria) transitional cell carcinoma of the urinary bladder. Efficacy has been demonstrated both in patients who have had no prior intravesical chemotherapy and in those who have failed such therapy with thiotepa or other antineoplastic agents.

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Mitomycin is contraindicated for intravesical administration in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past.

Acute Side Effects: Fever, hemolytic anemia, anorexia, stomatitis, hypoglycemia, mucositis and diarrhea have occurred.

Other Undesirable Side Effects: headache, blurring of vision, confusion, drowsiness, syncope, fatigue, weakness, edema, thrombophlebitis, hematemesis, nausea, vomiting, weight loss, ataxia and pain. It is difficult to determine whether these side effects are dose-related or due to the primary or metastatic disease process.

Genitourinary Irritation: Genitourinary irritation following intravesical administration indicated dysuria, cystitis, nocturia and increased frequency of micturition, hematuria, and other symptoms of local irritation. Approximately 25% of the patients treated experienced irritative symptoms, but not all were unequivocally drug-related and may have been symptoms of the disease.

Dermatitis: Dermatitis occurred in approximately 10% of the patients treated. It was commonly manifested as palmar rash with desquamation, generally appearing on the extremities and less often on the trunk, and also as genital rash. Topical steroids have been employed but their therapeutic value has not been determined.