VIRAMUNE TABLET 200 mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

NEVIRAPINE

可用日期:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC代码:

J05AG01

剂量:

200 mg

药物剂型:

TABLET

组成:

NEVIRAPINE 200 mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

BOEHRINGER INGELHEIM ELLAS A.E.

授权状态:

ACTIVE

授权日期:

1998-12-08

资料单张

1 

VIRAMUNE
®

abcd

COMPOSITION 
1 immediate release tablet contains:     

 200mg                                            

11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one  

(= nevirapine anhydrous) 
Excipients: cellulose, lactose monohydrate, povidone K 25, sodium starch glycolate, silicia colloidal, magnesium 
stearate 

1 ml oral suspension contains: 

      10mg 
11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido[3,2-b:2’,3’-e][1,4]diazepin-6-one 

(=nevirapine; as 10.35 mg nevirapine hemihydrate) 
Excipients: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, sucrose, polysorbate 80, 
sodium hydroxide, purified water 

DESCRIPTION  
Tablet: white, oval biconvex tablet.One side is embossed with
“54 193”, with a single bisect separating the “54” and 
“193”. The opposite side is marked with
a BI company symbol. 

Suspension: white to off-white off homogeneous suspension. 

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 

产品特点

1
VIRAMUNE
®
abcd
COMPOSITION
1 immediate release tablet contains:
200mg
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
(= nevirapine anhydrous)
Excipients: cellulose, lactose monohydrate, povidone K 25, sodium
starch glycolate, silicia colloidal, magnesium
stearate
1 ml oral suspension contains:
10mg
11-cyclopropyl-5,
11-dihydro-4-methyl-6H-dipyrido[3,2-b:2’,3’-e][1,4]diazepin-6-one
(=nevirapine; as 10.35 mg nevirapine hemihydrate)
Excipients: carbomer, methyl parahydroxybenzoate, propyl
parahydroxybenzoate, sorbitol, sucrose, polysorbate 80,
sodium hydroxide, purified water
DESCRIPTION
Tablet: white, oval biconvex tablet.One side is embossed with “54
193”, with a single bisect separating the “54” and
“193”. The opposite side is marked with a BI company symbol.
Suspension: white to off-white off homogeneous suspension.
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.
IN VITRO HIV SUSCEPTIBILITY:
The in vitro antiviral activity of nevirapine has been measured in a
variety of cell lines inc