DACARBAZINE injection, powder, for solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DACARBAZINE (UNII: 7GR28W0FJI) (DACARBAZINE - UNII:7GR28W0FJI)

Disponible des:

Hospira, Inc.

Designació comuna internacional (DCI):

DACARBAZINE

Composición:

DACARBAZINE 10 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection, USP is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents. Dacarbazine for Injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

Resumen del producto:

NDC 61703-327-22, 200 mg of Dacarbazine for Injection, USP per vial as sterile dacarbazine packaged in individual cartons.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DACARBAZINE- DACARBAZINE INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC.
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DACARBAZINE FOR INJECTION, USP
Rx only
WARNING
It is recommended that Dacarbazine for Injection be administered under
the supervision of a
qualified physician experienced in the use of cancer chemotherapeutic
agents.
1.
2.
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DESCRIPTION
Dacarbazine for Injection, USP is a colorless to an ivory colored
solid which is light sensitive. Each
vial contains 200 mg of dacarbazine (the active ingredient), citric
acid monohydrate and mannitol.
Dacarbazine for Injection, USP is reconstituted and administered
intravenously (pH 3 to 4). Dacarbazine
is an anticancer agent designated chemically as
5-(3,3-dimethyl-1-triazeno)-imidazole-4-carboxamide
with the following structural formula:
CLINICAL PHARMACOLOGY
After intravenous administration of Dacarbazine for Injection, the
volume of distribution exceeds total
body water content suggesting localization in some body tissue,
probably the liver. Its disappearance
from the plasma is biphasic with initial half-life of 19 minutes and a
terminal half-life of 5 hours. In a
Hemopoietic depression is the most common toxicity with Dacarbazine
for Injection (see
WARNINGS).
Hepatic necrosis has been reported (see WARNINGS).
Studies have demonstrated this agent to have a carcinogenic and
teratogenic effect when
used in animals.
In treatment of each patient, the physician must weigh carefully the
possibility of achieving
therapeutic benefit against the risk of toxicity.
patient with renal and hepatic dysfunctions, the half-lives were
lengthened to 55 minutes and 7.2 hours.
The average cumulative excretion of unchanged dacarbazine in the urine
is 40% of the injected dose in
6 hours. Dacarbazine is subject to renal tubular secretion rather than
glomerular filtration. At
therapeutic concentrations dacarbazine is not appreciably bound to
human plasma protein.
In man, dacarbazine is extensively degraded. Besides unchanged
dacarbazine, 5-aminoimidazole-4-
carboxamide (AIC) is a major metabolite of dacarbazine exc