HEPSERA adefovir dipivoxil 10mg tablet bottle

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

adefovir dipivoxil

थमां उपलब्ध:

Gilead Sciences Pty Ltd

प्राधिकरण का दर्जा:

Registered

सूचना पत्रक

HEPSERA Consumer Medicine Information (5 July 2016) Page 1 of 4
HEPSERA
 TABLETS
_10 mg adefovir dipivoxil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about HEPSERA.
It does not contain all 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
HEPSERA 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 HEPSERA
TABLETS ARE USED FOR
HEPSERA is used to treat chronic
hepatitis B in patients 12 years of age
or older.
Hepatitis B is caused by infection
with the hepatitis B virus (HBV)
which can damage the liver.
_HOW HEPSERA WORKS _
HEPSERA belongs to a group of
medicines called antiviral medicines.
HEPSERA reduces the amount of the
virus in your body, by lowering the
ability of the virus to multiply and
infect new liver cells and can
improve the inflammation and scar
tissue caused by the hepatitis B virus
in your liver. Lowering the amount
of virus in your body may reduce the
chance of developing cirrhosis, liver
failure and liver cancer.
We do not know how long
HEPSERA may help treat your
hepatitis. Sometimes viruses change
in your body and medicines no
longer work. This is called drug
resistance.
_USE IN CHILDREN _
HEPSERA is not recommended for
use in children under 12 years of age
as its safety and effectiveness in that
age group have not been established.
BEFORE YOU TAKE
HEPSERA
_WHO MUST NOT TAKE IT _
DO NOT TAKE HEPSERA IF YOU ARE
ALLERGIC TO:

adefovir dipivoxil or

any of the other ingredients of
HEPSERA.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

rash, itching or hives on the skin

swelling of the face, lips, tongue
or other p

उत्पाद विशेषताएं

Hepsera Product Information v14 (5 July 2016) Page 1 of 25
PRODUCT INFORMATION:
HEPSERA
® (ADEFOVIR DIPIVOXIL 10 MG) TABLETS
NAME OF THE MEDICINE
HEPSERA
The active ingredient in HEPSERA is adefovir dipivoxil.
Adefovir dipivoxil is a diester prodrug of adefovir, an acyclic
nucleotide analog of adenosine
monophosphate with activity against human hepatitis B virus (HBV).
Adefovir dipivoxil is
designated
chemically
as
9-[2
[[bis[(pivaloyloxy)-methoxy]phosphinyl]methoxy]
ethyl]adenine.
Chemical Structure:
N
N
N
N
O
P
O
O
NH
2
O
O
O
O
O
Molecular formula:
C
20
H
32
N
5
O
8
P
Molecular weight:
501.48
CAS Registry No.:
142340-99-6
DESCRIPTION
Adefovir dipivoxil is a white to off-white crystalline powder with an
intrinsic aqueous
solubility of 19 mg/mL at pH 2 and 0.4 mg/mL at pH 7.2. It has an
octanol/aqueous
phosphate buffer (pH 7) partition coefficient (_log p_) of 1.91.
HEPSERA tablets contain croscarmellose sodium, lactose monohydrate,
magnesium stearate,
pregelatinised maize starch, and talc.
PHARMACOLOGY
Adefovir
is
phosphorylated
to
the
active
metabolite,
adefovir
diphosphate,
by
cellular
kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse
transcriptase) by
competing with the natural substrate deoxyadenosine triphosphate and
by causing DNA chain
termination after its incorporation into viral DNA. The inhibition
constant (K
i
) for adefovir
diphosphate for HBV DNA polymerase was 0.1 µM.
Hepsera Product Information v14 (5 July 2016) Page 2 of 25
Adefovir diphosphate has an intracellular half-life of 12 to 36 hours
in activated and resting
lymphocytes. Adefovir diphosphate is a weak inhibitor of human DNA
polymerases α and γ
with K
i
values of 1.18 μM and 0.97μM, respectively.
PHARMACOKINETICS
The pharmacokinetics of adefovir have been evaluated in healthy adult
volunteers and adult
patients with chronic hepatitis B. Adefovir pharmacokinetics are
similar between these
populations. The pharmacokinetics of adefovir has also been
investigated in adult patients
with hepatic and renal impairment.
The