Viramune XR Tablet 400 mg

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Nevirapine Anhydrous

Disponible desde:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Código ATC:

J05AG01

Dosis:

400 mg

formulario farmacéutico:

TABLET, EXTENDED RELEASE

Composición:

Nevirapine Anhydrous 400 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

West-Ward Columbus Inc.

Estado de Autorización:

ACTIVE

Fecha de autorización:

2013-01-24

Información para el usuario

1 

abcd

VIRAMUNE
®

XR EXTENDED-RELEASE TABLET 

COMPOSITION 
1 extended-release tablet contains:                     

     400mg or 100 mg   
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one  
(= nevirapine anhydrous) 
Excipients: 

lactose monohydrate, hypromellose, iron
oxide (E172), magnesium stearate 

DESCRIPTION  
Extended-release
tablet: yellow, oval biconvex tablet (400mg); yellow, round
biconvex tablet (100mg). 

PHARMACOLOGICAL PROPERTIES  
Nevirapine is a non-nucleoside
reverse transcriptase inhibitor (NNRTI) of HIV-1. Nevirapine binds directly to
reverse 
transcriptase and blocks the
RNA-dependent and DNA-dependent DNA polymerase
activities by causing disruption 
of the enzyme's catalytic site. The
activity of nevirapine does not compete with template
or nucleoside triphosphates. 
HIV-2 reverse transcriptase and
eukaryotic DNA polymerases (such as human DNA polymerases 
α, β, γ, or δ) are not 
inhibited by nevirapine. 

In clinical studies, VIRAMUNE has been associated with
an increase in HDL- cholesterol and an overall improvement 
in the total to HDL-cholesterol ratio, which
in the general population would be considered to be associated
with a 
lower cardiovascular risk. However, in the absence
of specific studies with VIRAMUNE on modifying the 
cardiovascular risk in HIV infected patients, the
clinical impact of these findings is not known. The
selection of 
antiretroviral drugs must be guided
primarily by their antiviral efficacy. 

CLINICAL STUDIES 

VIRAMUNE XR EXTENDED-RELEASE TABLETS 
The clinical efficacy of VIRAMUNE XR extended-release
i

Ficha técnica

1
VIRAMUNE
®
XR EXTENDED-RELEASE TABLET
abcd
COMPOSITION
1 extended-release tablet contains:
400mg or 100 mg
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
(= nevirapine anhydrous)
Excipients:
lactose monohydrate, hypromellose, iron oxide (E172), magnesium
stearate
DESCRIPTION
Extended-release tablet: yellow, oval biconvex tablet (400mg); yellow,
round biconvex tablet (100mg).
PHARMACOLOGICAL PROPERTIES
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of HIV-1. Nevirapine binds directly to reverse
transcriptase and blocks the RNA-dependent and DNA-dependent DNA
polymerase activities by causing disruption of
the enzyme's catalytic site. The activity of nevirapine does not
compete with template or nucleoside triphosphates.
HIV-2 reverse transcriptase and eukaryotic DNA polymerases (such as
human DNA polymerases

,

,

, or

) are not
inhibited by nevirapine.
In clinical studies, VIRAMUNE has been associated with an increase in
HDL- cholesterol and an overall improvement
in the total to HDL-cholesterol ratio, which in the general population
would be considered to be associated with a
lower cardiovascular risk. However, in the absence of specific studies
with VIRAMUNE on modifying the
cardiovascular risk in HIV infected patients, the clinical impact of
these findings is not known. The selection of
antiretroviral drugs must be guided primarily by their antiviral
efficacy.
CLINICAL STUDIES
VIRAMUNE XR EXTENDED-RELEASE TABLETS
The clinical efficacy of VIRAMUNE XR extended-release is based on
48-week data from an ongoing, randomised,
double-blind, double-dummy Phase 3 trial (VERxVE - Study 1100.1486) in
treatment-naïve patients and on 24-week
data from an ongoing, randomised, open-label trial in patients who
transitioned from VIRAMUNE immediate-release
tablets administered twice daily to VIRAMUNE XR extended-release
tablets administered once daily (TRANxITION -
Study 1100.1526).
_Treatment-naïve patients_
VERxVE (Study 1100.1486) is a Phase 3 study