CYTOXAN TAB 25MG TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CYCLOPHOSPHAMIDE

Tilgængelig fra:

BRISTOL-MYERS SQUIBB CANADA

ATC-kode:

L01AA01

INN (International Name):

CYCLOPHOSPHAMIDE

Dosering:

25MG

Lægemiddelform:

TABLET

Sammensætning:

CYCLOPHOSPHAMIDE 25MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0107630003; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2008-11-21

Produktets egenskaber

PRODUCT MONOGRAPH
CYTOXAN*
(CYCLOPHOSPHAMIDE)
STERILE POWDER 100, 750, 1000 AND 2000 MG, U.S.P.
TABLETS 25 AND 50 MG, U.S.P.
ANTINEOPLASTIC AGENT
Bristol-Myers Squibb Canada
2365 Côte de Liesse Rd
Date of Preparation:
Montreal, Canada.
November 2, 2004
H4N 2M7
* TM of Mead Johnson & Company
Date of Revision:
used under license by Bristol-Myers Squibb Canada
Control No.: 094703
1
PRODUCT MONOGRAPH
CYTOXAN *
(CYCLOPHOSPHAMIDE)
Sterile powder 100, 750, 1000 and 2000 mg, U.S.P.
Tablets 25 and 50 mg, U.S.P.
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
CYTOXAN IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS
EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND
PRECAUTIONS). IN THOSE PATIENTS WHO DEVELOP BACTERIAL, FUNGAL, OR
VIRAL
INFECTIONS, MODIFICATION OF DOSAGE SHOULD BE CONSIDERED. BLOOD COUNTS
SHOULD BE TAKEN AT REGULAR INTERVALS.
ACTION AND CLINICAL PHARMACOLOGY
Cyclophosphamide is activated by metabolism in the liver by the
mixed-function oxidase system
of the smooth endoplasmic reticulum. The hepatic cytochrome P-450
mixed-function converts
cyclophosphamide to 4-hydroxycyclophosphamide, which is in a steady
state with the acyclic
tautomer, aldophosphamide. The drug and its metabolites are
distributed throughout the body
including the brain.
Cyclophosphamide, which is biologically relatively inactive, is
eliminated from the body very
slowly. The activated metabolites alkylate the target sites in
susceptible cells in an "all-or-none"
type of reaction or are detoxicated by formation of inactive
metabolites that are rapidly excreted
by the kidneys.
INDICATIONS AND CLINICAL USES
A.
Frequently responsive myeloproliferative and lymphoproliferative
disorders:
1.
Malignant lymphomas (Stages II to IV)
a)
Hodgkin's disease
b)
Mixed-cell type lymphoma
c)
Lymphocytic lymphoma
d)
Histiocytic lymphoma
e)
Lymphoblastic lymphosarcoma
f)
Burkitt's lymphoma
2.
Multiple myeloma.
3.
Leukemias:
a)
Chronic lymphocytic leukemia
b)
Chronic granulocytic leukemia (it is ineffective in acute blastic
crises)