Dacarbazine for injection 200mg Anticancer medicine
Each 20ml vial contains:200 mg dacarbazine.
Although the exact mechanism of action is unknown, three hypotheses
have been offered:
a) Inhibition of DNA synthesis by acting as a purine analogue.
b) Action as an alkylating agent.
c) Interaction with SH groups.
Metastatic malignant melanoma.
It is also indicated for the treatment of metastatic sarcoma in
combination with other chemotherapeutic drugs.
In addition Dacarbazine for injection has been shown, when used in combination with other cytotoxic
to be of value in other malignant diseases, including carcinomas of
colon, ovary, breast and lung and testicular teratoma.
DOSAGE AND DIRECTIONS FOR USE
Dacarbazine for injection 200 mg vials are reconstituted with 19,7
mL of Water for Injection. The resulting solution contains an
equivalent of 10 mg/mL of dacarbazine. After the solution has been
prepared, the calculated dose of the resulting solution is drawn
into a syringe and injected intravenously. Injection may be
completed in approximately one minute.
The following schedule is recommended:
2-4,5 mg/kg/day for 10 days which may be repeated at 3 week
intervals. It has been found that dacarbazine may be as efficacious
at the lower dosage as at the higher dosage. Combinations of cancer
chemotherapeutic agents have often shown an improved response over
the use of a single agent.
If desired, the reconstituted solution may be further diluted with
150-250 mL of 5% Dextrose for Injection or Normal Saline for
Injection and administered by intravenous infusion over a period of
ALL RECONSTITUTED SOLUTIONS MUST BE PROTECTED FROM LIGHT AND USED
WITHIN ONE HOUR.
Pregnancy, lactation and patients who are hypersensitive to
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Dacarbazine for injection should be administered preferably to
patients who are hospitalized and who can be observed carefully and
frequently during and after therapy, with particular reference to
the haemopoietic system. Studies have demonstrated this agent to
have a carcinogenic and teratogenic effect when used in animals. In
the treatment of each patient, the physician must weigh carefully
the possibility of achieving therapeutic benefit against the risk
of toxicity. Haemopoietic depression may be severe and lead to
fatality, although the total clinical experience suggests that it
is rarely necessary to transfuse patients with blood fractions.
Symptoms of anorexia, nausea and vomiting are the most frequently
noted of all toxic reactions. Over 90% of patients are affected
with the initial few doses.
The vomiting lasts 1-12 hours and is incompletely and unpredictably
palliated with phenobarbitone and/or proclorperazine.
Rarely Dacarbazine for injection has caused diarrhoea. Some helpful suggestions include restricting
the patient's oral intake of fluids and food for 4-6 hours prior to
treatment. The rapid toleration of these symptoms suggest that a
central nervous system mechanism may be involved, and usually these
symptoms subside after the first 1 or 2 days. Rarely, intractable
nausea and vomiting have necessitated discontinuance of Dacarbazine for injection therapy.
There are a number of minor toxicities that are infrequently noted.
Patients have experienced an influenza-like syndrome of fever,
myalgia and malaise. This syndrome usually occurs after large,
single doses approximately 7 days after treatment with Dacarbazine for injection, lasting 7-21 days, and it may recur with successive treatments.
Toxicity is enhanced when kidney malfunction occurs.
Alopecia has been noted as has facial flushing and facial
paraesthesias. Liver function impairment as indicated by increased
levels of SGOT and SGPT has been observed in a small percentage of
patients. However, generally this is a transient effect and levels
return to normal within two weeks. There have been no reports of
significant renal function test abnormalities.
Protect from light. Store between 2°C to 8°C.
KEEP OUT OF REACH OF CHILDREN.