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.