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COSMEGEN LYOVAC
2014-01-15 11:31:00 来源: 作者: 【 】 浏览:410次 评论:0

Drug Class Description

Cytotoxic antibiotics.

Generic Name

Dactinomycin

Drug Description

Yellow lyophilised powder in vial.

Presentation

Powder for injection, dactinomycin 0.5 mg .

Indications

Recommended only for the treatment, under appropriate supervision, of hospitalised patients with Wilms' tumour, rhabdomyosarcoma, and carcinoma of the testis or uterus. All other indications for dactinomycin are as yet experimental (e.g. Ewing's sarcoma, osteogenic sarcoma). See data sheet.

Adult Dosage

Usually 500 micrograms daily for a maximum of five days by intravenous injection. See data sheet for further information.

Child Dosage

Under 12 months, not normally recommended; over 12 months, 15 micrograms per kg body weight daily for a maximum of 5 days by intravenous injection. Alternatively, a total dosage of 2,500 micrograms per square metre of body weight intravenously over of body weight intravenously over a one-week period. See data sheet.

Contra Indications

If 'Cosmegen' is given at or about the time of infection with chickenpox or herpes zoster, a severe generalised disease, which may be fatal, can occur.

Special Precautions

To be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Handle powder and solution with care. Avoid extravasation.

Monitor patients closely for adverse reactions. Concurent x-ray therapy. Administration within two months of irradiation for the treatment of right-sided Wilms' tumour, since hepatomegaly and elevated AST (SGOT) levels have been seen. Nausea and vomiting due to dactinomycin make it necessary to give 'Cosmegen' intermittently. Dactinomycin can adversely affect male fertility.

Interactions

May potentiate the effects of x- ray therapy. 'Cosmegen' may be more effective when radiation therapy is given concurrently.

Adverse Reactions

Toxic effects (except nausea and vomiting) do not usually become apparent until two to four days after a course of therapy is stopped, and may not reach a maximum before one to two weeks have elapsed. Deaths have been reported. However, side effects are usually reversible on discontinuing therapy, they include the following: General: malaise, fatigue, lethargy, fever, myalgia, proctitis, hypocalcaemia. Oral: cheilitis, dysphagia, oesophagitis, ulcerative stomatitis, pharyngitis.

Gastro-intestinal: anorexia, nausea, vomiting, abdominal pain, diarrhoea, gastro-intestinal ulceration, liver toxicity including ascites, hepatomegaly, hepatitis and liver-function test abnormalities. Nausea and vomiting, which occur early administration, may be alleviated by giving anti-emetics. Haematological: anaemia (even to the point of aplastic anaemia, agranulocytosis, leucopenia, thrombocytopenia, pancytopenia, reticulocytopenia). Platelet and white blood-cell counts should be done daily to detect severe haemopoietic depression. If either count shows a marked decrease, dactinomycin should be withheld to allow marrow recovery. This often takes up to three weeks.

Dermatological: alopecia, skin eruptions, acne, flare-up of erythema or increased pigmentation of previously irradiated skin. Soft tissues: dactinomycin is extremely corrosive to soft tissues. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance this has led to contracture of the arms.

Manufacturer

MSD

Drug Availability

(POM)

Updated

05 May 2009 
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