Land: Canada
Taal: Engels
Bron: Health Canada
DIDANOSINE
BRISTOL-MYERS SQUIBB CANADA
J05AF02
DIDANOSINE
50MG
TABLET
DIDANOSINE 50MG
ORAL
60
Prescription
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0123132003; AHFS:
CANCELLED POST MARKET
2005-08-01
PRODUCT MONOGRAPH VIDEX* (DIDANOSINE) VIDEX* CHEWABLE / DISPERSIBLE BUFFERED TABLETS VIDEX* BUFFERED POWDER FOR ORAL SOLUTION VIDEX* PEDIATRIC POWDER FOR ORAL SOLUTION ANTIRETROVIRAL AGENT Bristol-Myers Squibb Canada Date of Preparation: Montreal, Canada October 8, 1991 * TM of Bristol-Myers Squibb Company Date of Revision: used under license by Bristol-Myers Squibb Canada August 29, 2003 Control #: 078805 1 PRODUCT MONOGRAPH VIDEX* (DIDANOSINE) VIDEX* Chewable / Dispersible Buffered Tablets VIDEX* Buffered Powder for Oral Solution VIDEX* Pediatric Powder for Oral Solution THERAPEUTIC CLASSIFICATION Antiretroviral Agent ACTIONS AND CLINICAL PHARMACOLOGY Didanosine is a synthetic, purine nucleoside analogue of deoxyadenosine, active against the Human Immunodeficiency Virus (HIV). Didanosine inhibits the _in vitro_ replication of HIV in human primary cells cultures and in established cell lines. The active antiviral metabolite, dideoxyadenosine-triphosphate (ddATP), is formed in several steps by phosphorylation of didanosine by cellular enzymes. Inhibition of HIV reverse transcriptase by ddATP is through competition with endogenous deoxyadenosine triphosphate (dATP) for binding to the active site of the enzyme. In addition, ddATP is a substrate for reverse transcriptase and is incorporated into the growing DNA chain. The resulting nucleoside, dideoxyadenosine (ddA) lacks a 3'-hydroxyl group, which normally is the acceptor for covalent attachment of subsequent nucleoside 5'-monophosphates in DNA chain extension. Thus, ddA incorporated in the DNA prevents further chain extension and aborts proviral DNA synthesis. (See CLINICAL PHARMACOLOGY). INDICATIONS AND CLINICAL USE VIDEX (didanosine) is indicated for the treatment of HIV-infected patients in appropriate antiretroviral regimens. Clinical benefit of VIDEX was demonstrated in several important clinical trials (see Clinical Use subsection of CLINICAL PHARMACOLOGY). The duration of clinical benefit from antiretroviral therapy may be limited. Alteration in antiretrovi Lees het volledige document