ENTECAVIR AMNEAL 0.5mg entecavir (as monohydrate) tablet, bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

entecavir, Quantity: 0.5 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Entecavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.,This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease

Product summary:

Visual Identification: White to off white triangular shaped coated tablet debossed with "ENT" on one side and "0.5" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-07-22

Patient Information leaflet

_Entecavir tablets – Consumer Medicine Information _
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_E CMI v 0.1 _
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_Page 1 _
ENTECAVIR AMNEAL TABLETS
_Entecavir monohydrate (en-TEH-cuh-veer mon-O-HI-drate )_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Entecavir AMNEAL. This
leaflet answers some common
questions about Entecavir
AMNEAL.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Entecavir
AMNEAL against the benefits
they expect it will have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the
medicine. You may need to read it
again.
WHAT ENTECAVIR
AMNEAL IS USED FOR
Entecavir AMNEAL contains
entecavir monohydrate and
belongs to a group of medicines
called antiviral medicines.
Entecavir AMNEAL is used to
treat adults infected with hepatitis
B virus.
_HOW ENTECAVIR AMNEAL _
_WORKS _
Infection by the hepatitis B virus
can lead to damage to the liver.
Entecavir AMNEAL reduces the
amount of virus in your body, and
has been shown to improve the
condition of the liver.
It is not known how safe Entecavir
AMNEAL is when taken for long
periods.
Your doctor may have prescribed
Entecavir AMNEAL for another
reason. Ask your doctor if you have
any questions about why Entecavir
AMNEAL has been prescribed for
you.
ENTECAVIR AMNEAL IS NOT
ADDICTIVE. THIS MEDICINE IS
AVAILABLE ONLY WITH A DOCTOR'S
PRESCRIPTION.
Entecavir AMNEAL is not
recommended for use in children
under 16 years, as there have been
no studies of its effects in children
.
.
.
BEFORE YOU TAKE
ENTECAVIR AMNEAL
IT IS IMPORTANT THAT YOU CHECK
THE INFORMATION BELOW BEFORE
YOU TAKE ENTECAVIR AMNEAL.
_WHEN YOU MUST NOT TAKE _
_ENTECAVIR AMNEAL_
You must not take Entecavir
AMNEAL if you have a history of
severe allergic reactions to
Entecavir AMNEAL or to any of
the ingredients listed at the end of
this leaflet. Symptoms of a se

Summary of Product characteristics

1
Entecavir AMNEAL PI v1.0
PRODUCT INFORMATION
ENTECAVIR AMNEAL
(entecavir)
Film coated tablet
NAME OF THE MEDICINE
Entecavir monohydrate, is a guanosine nucleoside analogue with
selective activity against hepatitis
B
virus (HBV). The chemical name for entecavir monohydrate is
2-amino-1,9-dihydro-9-
[(
_1S,3R,4S_
)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6
_H_
-purin-6-one,
monohydrate.
Its molecular formula is C
12
H
15
N
5
O
3
•
H
2
O, which corresponds to a molecular weight
of 295.3.
Entecavir monohydrate has the following structural formula:
CAS number: 209216-23-9
DESCRIPTION
Entecavir
monohydrate
is
a
white
to
off-white
powder.
It
is
slightly
soluble
in
water
(2.4
mg/mL), and the pH of the saturated solution in water is 7.9 at 25°
±
0.5°
C.
Entecavir AMNEAL film-coated tablets are available for oral
administration in strengths of 0.5
mg
and 1 mg of entecavir (as monohydrate).
Entecavir AMNEAL 0.5 mg and 1 mg film-coated tablets contain the
following inactive
ingredients: lactose monohydrate, microcrystalline cellulose,
crospovidone
and magnesium stearate.
The 0.5 mg tablet coating contains Opadry II white 85F28751 (macrogol
3000, purified talc,
titanium dioxide, polyvinyl alcohol) , and the 1 mg tablet coating
contains Opadry II pink
85F24151 (polyvinyl alcohol, titanium dioxide (E171), macrogol 3000,
purified talc, iron oxide red)
2
Entecavir AMNEAL PI v1.0
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
_MECHANISM OF ACTION _
- Entecavir is a guanosine nucleoside analogue with activity
against HBV
polymerase. It is phosphorylated to the active triphosphate (TP) form,
which has an intracellular half-
life of 15 hours. Intracellular TP levels are directly related to
extracellular entecavir concentrations,
with no significant accumulation beyond initial plateau
levels. By competing with the natural
substrate deoxyguanosine-TP, entecavir -TP inhibits all 3 functional
activities of the viral polymerase:
(1) priming of the HBV polymerase, (2) reverse transcription
of
the
negative
strand
from
the
pregenomi