cyclophosphamide- Cyclophosphamide tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

cyclophosphamide (UNII: 8N3DW7272P) (cyclophosphamide - UNII:8N3DW7272P)

Disponible desde:

Roxane Laboratories, Inc.

Designación común internacional (DCI):

Cyclophosphamide

formulario farmacéutico:

TABLET

Composición:

25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cyclophosphamide tablets, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. The following malignancies are often susceptible to cyclophosphamide treatment: - Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lyphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma. - Multiple myeloma. - Leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia; acute lymphoblastic (stem-cell) leukemia in children (cyclophosphamide given during remission is effective in prolonging its duration). - Mycosis fungoides (advanced disease). - Neuroblastoma (disseminated disease). - Adenocarcinoma of the ovary. - Retinoblastoma. - Carcinoma of the breast. Cyclophosphamide tablets are useful in carefully selected cases of biopsy proven “minimal c

Resumen del producto:

Cyclophosphamide is available as: 25 mg light blue, round, unscored tablets (Identified 54 639) NDC 0054-8089-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4129-25: Bottles of 100 tablets. 50 mg light blue, round, unscored tablets (Identified 54 980) NDC 0054-8130-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4130-25: Bottles of 100 tablets. Storage at or below 77°F (25°C) is recommended; this product will withstand brief exposure to temperatures up to 86°F (30°C) but should be protected from temperatures above 86°F (30°C).   4047200//01 April 2001 Roxane Laboratories, Inc. Columbus, Ohio 43216 © RLI, 2001

Ficha técnica

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE TABLET
ROXANE LABORATORIES, INC.
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CYCLOPHOSPHAMIDE TABLETS USP, 25 MG AND 50 MG
Rx only
DESCRIPTION
Cyclophosphamide is a synthetic antineoplastic drug chemically related
to the nitrogen mustards.
Cyclophosphamide is a white crystalline powder with the molecular
formula C H Cl
N O P · H O
and a molecular weight of 279.10. The chemical name for
cyclophosphamide is 2-[Bis(2-
chloroethyl)amino]tetrahydro-2_H_-1,3,2-oxazaphosphorine 2-oxide
monohydrate. Cyclophosphamide is
soluble in water, saline, or ethanol and has the following structural
formula:
Each tablet for oral administration contains cyclophosphamide USP
(calculated as anhydrous) 25 or 50
mg. In addition, each tablet contains the following inactive
ingredients: acacia, FD&C Blue No. 1,
lactose monohydrate, magnesium stearate, and microcrystalline
cellulose.
CLINICAL PHARMACOLOGY
Cyclophosphamide is biotransformed principally in the liver to active
alkylating metabolites by a mixed
function microsomal oxidase system. These metabolites interfere with
the growth of susceptible
rapidly proliferating malignant cells. The mechanism of action is
thought to involve cross-linking of
tumor cell DNA.
Cyclophosphamide is well absorbed after oral administration with a
bioavailability greater than 75%.
The unchanged drug has an elimination half-life of 3 to 12 hours. It
is eliminated primarily in the form
of metabolites, but from 5 to 25% of the dose is excreted in urine as
unchanged drug. Several cytotoxic
and noncytotoxic metabolites have been identified in urine and in
plasma. Concentrations of metabolites
reach a maximum in plasma 2 to 3 hours after an intravenous dose.
Plasma protein binding of unchanged
drug is low but some metabolites are bound to an extent greater than
60%. It has not been demonstrated
that any single metabolite is responsible for either the therapeutic
or toxic effects of
cyclophosphamide. Although elevated levels of metabolites of
cyclophosphamide have been observed
in patients with renal failure,