情報リーフレット
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ATRIPLA CMI v2.1 – (19January2010)
CONSUMER MEDICINE
INFORMATION
ATRIPLA
®
TABLETS
(300 MG TENOFOVIR DISOPROXIL
FUMARATE / 200 MG
EMTRICITABINE/ 600 MG
EFAVIRENZ)
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
This leaflet answers some of the
common questions about
ATRIPLA tablets. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist about your medical
condition or treatment. If you
have further questions, please ask
your doctor or your pharmacist.
Keep this leaflet with your
ATRIPLA medicine. You may
need to read it again.
This medicine has been
prescribed for you personally and
you should not pass it on to
others. It may harm them, even
if their symptoms are the same as
yours.
WHAT IS ATRIPLA?
• ATRIPLA consists of three
medicines VIREAD
®
(tenofovir disoproxil
fumarate, also called
tenofovir DF), EMTRIVA
®
(emtricitabine or FTC) and
STOCRIN
®
(efavirenz)
combined in one tablet.
• VIREAD and EMTRIVA
belong to a group of antiviral
medicines known as
nucleoside and nucleotide
reverse transcriptase
inhibitors (NRTI) and
STOCRIN belongs to a group
of antiviral medicines known
as non-nucleoside reverse
transcriptase inhibitors
(NNRTI). Tenofovir DF and
emtricitabine are the
components of TRUVADA
®
tablets.
• ATRIPLA is used to treat
Human Immunodeficiency
Virus (HIV) infection in
adults. This medicine can be
taken alone or in combination
with other anti-HIV
medicines.
• HIV infection destroys CD4
+
T cells, which are important
to the immune system. The
immune system helps fight
infection. After a large
number of T cells are
destroyed, acquired immune
de
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製品の特徴
ATRIPLA Product Information v8.0 – (3 September2013) Page 1 of 32
PRODUCT INFORMATION
ATRIPLA
®
(TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND EFAVIRENZ)
TABLETS
NAME OF THE MEDICINE
ATRIPLA (300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/600 mg efavirenz)
tablets.
The active substances in ATRIPLA tablets are tenofovir disoproxil fumarate (tenofovir DF),
emtricitabine and efavirenz.
VIREAD
®
is the brand name for tenofovir DF, which is converted _in vivo_ to tenofovir, an acyclic
nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. EMTRIVA
®
is the
brand name for emtricitabine (FTC), a synthetic nucleoside analog of cytidine. STOCRIN
_®_
is the
brand name for efavirenz, a non-nucleoside reverse transcriptase inhibitor. All three compounds
exhibit activity against HIV-1 reverse transcriptase. Tenofovir DF and emtricitabine are the
components of TRUVADA
®
.
DESCRIPTION
_TENOFOVIR DISOPROXIL FUMARATE_: Tenofovir DF is a fumaric acid salt of the _bis_-
isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF
is
9-[(_R_)-2
[[bis[[(isopropoxycarbonyl)oxy]
methoxy]phosphinyl]methoxy]propyl]adenine
fumarate (1:1). It has a molecular formula of C
19
H
30
N
5
O
10
P
C
4
H
4
O
4
and a molecular weight of
635.52. It has the following structural formula:
N
N
N
N
O
P
O
O
O
O
O
O
NH
2
CH
3
CO
2
H
H
HO
2
C
H
O
O
O
CAS registry number: 202138-50-9
Tenofovir DF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water
at 25
C. The partition coefficient (_log p_)
for tenofovir disoproxil is 1.25 and the pKa is 3.75.
_
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