国家: 加拿大
语言: 英文
来源: Health Canada
MITOMYCIN
ACCORD HEALTHCARE INC
L01DC03
MITOMYCIN
20MG
POWDER FOR SOLUTION
MITOMYCIN 20MG
INTRAVENOUS
39ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0111533002; AHFS:
APPROVED
2017-06-09
PRODUCT MONOGRAPH Pr MITOMYCIN FOR INJECTION USP 20 mg mitomycin per vial Sterile Lyophilized powder Antineoplastic Agent Accord Healthcare Inc. 3535 Boul. St-Charles, Suite 704 Kirkland, Qc H9H 5B9 Canada Date of Revision: July 16, 2018 Control #: 216814 Page 2 of 16 PRODUCT MONOGRAPH PR MITOMYCIN FOR INJECTION USP 20 mg mitomycin per vial THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION: MITOMYCIN IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS SHOULD BE TAKEN WEEKLY. MITOMYCIN MUST BE DISCONTINUED OR DOSAGE REDUCED UPON EVIDENCE OF ABNORMAL DEPRESSION OF THE BONE MARROW OR THE DEVELOPMENT OF SIGNIFICANT RENAL OR PULMONARY TOXICITY. ACTION AND CLINICAL PHARMACOLOGY 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. In humans, mitomycin is rapidly cleared from the plasma after intravenous administration with a biphasic plasma elimination curve. 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 µg / mL, 1.7 µg / mL and 0.52 µg / mL, respectively. In general, the smaller the dose, the more rapidly blood levels of mitomycin decreased. Clearance is affected primarily by metabolism in the liver, but metabolism occurs in other tissues as well. Approximately 10% of a dose of mitomycin is excreted unchanged in the urine. Since metabolic pathways are saturated at relatively low doses, the percent of a dose excreted in urine increases with increasing doses. In c 阅读完整的文件