VIDEX CHEWABLE DISPERSIBLE TAB 50MG TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DIDANOSINE

Saatavilla:

BRISTOL-MYERS SQUIBB CANADA

ATC-koodi:

J05AF02

INN (Kansainvälinen yleisnimi):

DIDANOSINE

Annos:

50MG

Lääkemuoto:

TABLET

Koostumus:

DIDANOSINE 50MG

Antoreitti:

ORAL

Kpl paketissa:

60

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0123132003; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2005-08-01

Valmisteyhteenveto

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