Dacarbazine


Injection U.S.P.
 

COMPOSITION:
Each vial contains:
Dacarbazine U.S.P. 200 mg.
Citric Acid U.S.P.q.s
Mannitol U.S.P. q.s


PREPARATION OF SOLUTION:
Reconstitute with 20 ml sterile water for injections so that the reconstituted solution will contain 10 mg / ml of Dacarbazine.

STORAGE:
Store under refrigeration (2-8° C). Protect from light.

ACTIONS:
Dacarbazine acts:
1. By inhibiting purine metabolism and nucleic acid synthesis by acting as a purine analog.
2. By acting as an alkylating agent.
3. By interaction with SH-groups.

INDICATIONS:
Metastatic malignant melanoma, Hodgkin's lymphoma

CONTRAINDICTIONS:
Contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

WARNINGS:
Hemopoietic depression is the most common toxicity and involves primarily the leucocytes and platelets. Depression of the erythrocyte count may also occur. These effects could sometimes be fatal.

PREGNANCY:
Dacarbazine should be used during pregnancy only if potential benefits justify the possible risks to the fetus.

ADVERSE REACTIONS:
Anorexia, nausea, vomiting are frequently observed. Alopecia, facial flushing, paresthesia, urticarial rashes, anaphylaxis are rarely observed.

OVERDOSAGE:
Give supportive treatment & monitor blood cell counts.

DOSAGE AND ADMINISTRATION:
In Metastic Malignant Melanoma the recommended daily intravenous dosage is 250 mg per meter square body surface for 5 days, and the cycle repeated after 3 weeks interval OR 2 to 4.5 mg per kg body weight for 10 days and repeated after 4 week intervals.

In the treatment of Hodgkin's disease the recommended daily intravenous dosage is 150 mg per meter square body surface area for 5 days repeated every 4 weeks OR 375 mg per meter square body surface area every 15 days in association with other antineoplastic agents.

Copyright © 2009 Serum Institute of India Limited. Legal Disclaimer.