CYCLOPHOSPHAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOPHOSPHAMIDE (UNII: 8N3DW7272P) (CYCLOPHOSPHAMIDE - UNII:8N3DW7272P)

Available from:

Physicians Total Care, Inc.

INN (International Name):

CYCLOPHOSPHAMIDE

Composition:

CYCLOPHOSPHAMIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclophosphamide Tablets USP, 25 mg and 50 mg, 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, lymphocytic 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 USP, 25 mg and 50 mg are useful in carefully s

Product summary:

Cyclophosphamide Tablets USP 25 mg, light blue, round, unscored tablets (Identified 54 639) NDC 54868-5218-0: Bottle of 100 tablets NDC 54868-5218-1: Bottle of 10 tablets. 50 mg, light blue, round, unscored tablets (Identified 54 980) NDC 54868-5005-0: Bottle of 100 tablets. Storage at or below 25°C (77°F) is recommended; this product will withstand brief exposure to temperatures up to 30°C (86°F) but should be protected from temperatures above 30°C (86°F). Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing cyclophosphamide tablets. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration. 4047201//03 Revised September 2007 © RLI, 2007 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOPHOSPHAMIDE - CYCLOPHOSPHAMIDE TABLET
PHYSICIANS TOTAL CARE, 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 279.1. The chemical name for
cyclophosphamide is 2_H_-1,3,2-
Oxazaphosphorin-2-amine, _N,N_-bis(2-chloroethyl)tetrahydro-, 2-oxide,
monohydrate, (±).
Cyclophosphamide is soluble in water, saline, or ethanol and has the
following structural formula:
Each tablet for oral administration contains cyclophosphamide
(anhydrous) 25 mg 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 failur