CYCLOPHOSPHAMIDE Coated Tablet Ref.[6752] Active ingredients: Cyclophosphamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Pharmacodynamic properties

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

Pharmacokinetic properties

Cyclophosphamide is well absorbed following an oral dose with a mean half-life of 4-8 hours for both oral and parenteral administration.

It is an inactive pro drug with alkylating metabolites produced by hepatic metabolism, reaching peak levels 4-6 hours after an iv injection. Hepatic enzymes may be induced. The parent compound binds poorly to plasma protein but the active metabolites are significantly protein-bound. The drug is widely distributed and crosses the blood-brain barrier, the placental barrier and is found in ascites. The metabolites are excreted renally.

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to the information already stated in other sections of the Summary of Product Characteristics.

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