Arrow - Stavudine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Stavudine 40mg

Available from:

Actavis New Zealand Limited

INN (International Name):

Stavudine 40 mg

Dosage:

40 mg

Pharmaceutical form:

Capsule

Composition:

Active: Stavudine 40mg Excipient: Gelatin Lactose Liquid paraffin Magnesium stearate Purified water Sodium laurilsulfate   Sodium starch glycolate TekPrint black SW-9008 Titanium dioxide

Units in package:

Bottle, plastic, HDPE with CRC, 60 capsules, 60 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Arrow - Stavudine is indicated for the treatment of HIV-infected patients (over the age of 5 months) for whom zidovudine therapy is not, or is no longer, appropriate.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with CRC, 60 capsules - 60 capsules - 24 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2008-02-07

Summary of Product characteristics

ARROW - STAVUDINE 
Stavudine Capsules 40mg 
PRESENTATION 
Arrow - Stavudine is a white capsule containing white to off-white powder, with “STN-
40” on both the cap and the body printed in black.  Each capsule contains 40 mg of 
Stavudine. 
This product is not able to deliver all approved dose regimens.

USES 
_ACTIONS _
Stavudine is a synthetic thymidine analogue active against the Human 
Immunodeficiency virus (HIV).  Stavudine inhibits the replication of HIV in human 
cells _in vitro_. It is phosphorylated by cellular kinases to stavudine triphosphate which 
inhibits HIV reverse transcriptase by competing with the natural substrate, 
deoxythymidine triphosphate.  It also inhibits viral DNA synthesis by causing DNA 
chain termination due to a lack of the 3'-hydroxyl group necessary for DNA 
elongation.  Stavudine triphosphate reduces synthesis of mitochondrial DNA by 
inhibiting cellular polymerase gamma, but is 100-fold less active against cellular DNA 
polymerase alpha and beta. 
Although the clinical efficacy is well established, a relationship between _in vitro _
susceptibility of HIV to stavudine and inhibition of HIV replication in humans or 
clinical response to therapy has not been well established. 
Stavudine triphosphate has an intracellular half-life of 3.5 hours in CEM T-cells and 
peripheral blood mononuclear cells. 
Reductions in sensitivity to stavudine of some HIV-1 strains has been observed in _in _
_vitro _selection studies and in some pairs of pre-treatment and post-treatment HIV-1 
isolates from clinical studies.  Some stavudine post-treatment isolates were resistant 
to didanosine and/or zidovudine.  The relationship between stavudine treatment and 
the appearance of resistance to didanosine and zidovudine is unexplained. 
_In vitro�