生产厂家英文名：Nobel Pharma Corporation
原产地英文商品名：COSMEGEN IV Injection(コスメゲン静注用)0.5MG/vial
商品名：COSMEGEN IV Injection 0.5mg
生产商：Nobel Pharma Corporation
商品名：COSMEGEN IV Injection 0.5mg
一般名：アクチノマイシンD (Actinomycin D)
Specific stereoisomer of N , N ‘-[(2-amino-4, 6-dimethyl-3-oxo-3H-phenoxazine-1, 9-diyl)-bis[carbonylimino(2-hydroxypropylidene)carbonyliminoisobutylidenecarbonyl-1, 2-pyrrolidinediyl carbonyl (methylimino)methylenecarbonyl]]-bis[N -methyl-L-valine]dilactone
Cosmegen (Dactinomycin)COSMEGEN®MSDDactinomycinAntineoplasticAction AndClinical Pharmacology: Dactinomycin is an antibiotic obtained as the principalcomponent of the mixture of actinomycins produced by S. parvullus. Thisorganism, unlike other species, yields an essentially pure substance thatcontains only traces of similar compounds differing in the amino acid content of the peptide side chains. It is available for clinical use as a sterile, yellowl yophilized powder which, in aqueous solution, produces a clear gold color.Generally, the actinomycins exert an inhibitory effect on gram positive and gram negative bacteria and on some fungi. However, the toxic properties of the actinomycins (including dactinomycin) in relation to antibacterial activity are such as to preclude their use as antibiotics in the treatment of infectious diseases.Because the actinomycins are cytotoxic, they have an antineoplastic effect which has been demonstrated in experimental animals with various types of tumor implant. This cytotoxic action is the basis for their use in the palliative treatment of certain types of cancer.Pharmacokinetics: Results of a study in patients with malignant melanoma indicate that dactinomycin (actinomycin D) is minimally metabolized, is concentrated in nucleated cells, and does not penetrate the blood brain barrier. Approximately 30% of the dose was recovered in urine and feces in one week. The terminal plasma half-life for radioactivity was approximately 36 hours.Indications And Clinical Uses: Wilms ’Tumor: Theneoplasm responding most frequently to dactinomycin is Wilms’ tumor.With low doses of both dactinomycin and radiotherapy, temporary objective improvement may be as good as and may last longer than with higher doses of each given alone. In the National Wilms’ Tumor study, combination therapy with dactinomycin and vincristine together with surgery and radio therapy, was shownto have significantly improved the prognosis of patients in groups II and III.Dactinomycin and vincristine were given for a total of seven cycles, so thatmaintenance therapy continued for appro ximately 15 months Postoperati veradiotherapy in group I patients and optimal combination chemotherapy for thosein group IV are unsettled issues. About 70% of lung metastases have disappeared with an appropriate combination of radiation, dactinomycin andvincristine.Rhabdomyosarcoma: Temporary regression of the tumor and beneficialsubjective results have occurred with dactinomycin in rhabdomyosarcoma which,like most soft tissue sarcomas, is comparatively radioresistant.Several groupshave reported successful use of cyclophosphamide, vincristine, dactinomycin anddoxorubicin hydrochloride in various combinations. Effective combinations haveincluded vincristine and dactinomycin; vincristine, dactinomycin andcyclopho sphamide (VAC therapy) and all 4 drugs in sequence. At present, the mosteffective treatment for children with inoperable or metastatic rhabdomyosarcomahas been VAC chemotherapy. Two-thirds of these children were doing well withoutevidence of disease at a median time of three years after diagnosis.Carcinoma ofTestis and Uterus: The sequential use of dactinomycin and methotrexate, alongwith meticulous monitoring of human chorionic gonadotropin levels until normal,has resulted in survival in the majority of women with metastaticchoriocarcinoma. Sequential therapy is used if there is: stability ingonadotropin titers following two successive courses of an agent; risinggonadotropin titers during treatment; severe toxicity preventing adequatetherapy.In patients with nonmetastatic choriocarcinoma, dactinomycin ormethotrexate or both have been used successfully, with or withoutsurgery.Dactinomycin has been beneficial as a single agent in the treatment ofmetastatic non-seminomatour testicular carcinoma when used in cycles of 500Âµg/day for 5 consecutive days, every 6 to 8 weeks for periods of four months orlonger.Other Neoplasms: Dactinomycin has been given i.v. or by regionalperfusion, either alone or with other antineoplastic compounds or x-ray therapy,in the palliative treatment of Ewing’s sarcoma and sarcoma botryoides. Fornon-metastatic Ewing’s sarcoma, promising results were obtained whendactinomycin (45 Âµg/m and cyclophosphamide (1 200 mg/m were given sequentiallyand withradiotherapy, over an 18 month period.