ACICLOVIR AN aciclovir 800mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aciclovir, Quantity: 800 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Aciclovir

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

120 tablets, 35 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advaned symptomatic HIV disease CD4 + counts < 150 x 10(6)/L). In accordance with details specified in the "Indications" and the "Dosage and Administration" sections of the approved product information provided as Attachment 1.

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex tablets, with 'ACV' embossed on one side and '800' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-08-09

Patient Information leaflet

_Aciclovir AN tablets – Consumer Medicine Information _
_Doc ID: 36.AN.M.1.0 _
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_Page 1 _
ACICLOVIR AN TABLETS
_Aciclovir _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
ACICLOVIR AN (aciclovir).
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
this
medicine
against
the
benefits it is expected to have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
Keep
this
leaflet
with
your
medicine. You may need to read
it again.
WHAT ACICLOVIR AN
IS USED FOR
ACICLOVIR
AN
contains
aciclovir,
a
compound
that
belongs to a group of medicines
called antivirals.
ACICLOVIR AN is used for the
treatment
of
shingles
(herpes
zoster), impaired immunity and
genital herpes.
In
the
case
of
shingles,
ACICLOVIR
AN
works
by
stopping the multiplication of the
virus which causes shingles. It
can
reduce
the
length
and
severity
of
an
outbreak
of
shingles but it will not get rid of
the virus from your body.
Aciclovir at high strength is used
as
part
of
the
management
program
in
people
who
have
human
immunodeficiency
virus
disease
(HIV).
It
acts
by
preventing further damage to the
immune
system.
In
these
people,
ACICLOVIR
AN
also
guards against the herpes virus
disease.
Aciclovir does not get rid of the
virus from your body.
Your
doctor
may
have
prescribed
ACICLOVIR
AN
for
another purpose.
ACICLOVIR
AN
is
not
recommended for use in children
as there have been no studies of
its effects in children.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
ACICLOVIR
AN
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
BEFORE YOU TAKE
ACICLOVIR AN
_WHEN YOU MUST NOT TAKE _
_ACICLOVIR AN _
DO NOT TAKE ACICLOVIR AN IF YOU
ARE
ALLERGIC
TO
MEDICINES
CONTAINING ACICLOVIR OR ANY OF
THE
INGREDIENTS
LISTED
AT
THE
END OF THIS LEAFLET.
Some
of
the
symptoms
of
a

Summary of Product characteristics

_Aciclovir AN tablets Product Information _
_ _
_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 36.AN.P.1.0
Page 1
ACICLOVIR AN
_ _
_(ACICLOVIR TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is aciclovir
CHEMICAL NAME: 9-((2-hydroxyethoxy) methyl) guanine
MOLECULAR FORMULA: C
8
H
11
N
5
O
3
MOLECULAR WEIGHT: 225.2
CAS NO:_ [59277-89-3]_
DESCRIPTION
Synthetic acyclic purine nucleoside analogue. It is a white
crystalline powder.
_Excipients _
–
magnesium
stearate,
microcrystalline
cellulose,
sodium
starch
glycollate,
pregelatinised maize starch, colloidal anhydrous silica.
PHARMACOLOGY
ACTIONS – Antiviral agent.
MICROBIOLOGY
Aciclovir is an antiviral agent which is active in vitro against _
Herpes simples _ virus (HSV)
types I and II and _ Varicella zoster _ virus (VZV), the latter being
considerably less sensitive.
The relationship between the level of in vitro sensitivity of herpes
viruses to aciclovir and
clinical response to therapy has not been adequately established.
Development of resistance
by
HSV to aciclovir has been documented. Aciclovir needs to be
phosphorylated to the
active
compound,
aciclovir
triphosphate,
in
order
to
become
active
against
the
virus.
Such
conversion is very limited in normal cells and, in addition, cellular
DNA polymerase is not
very sensitive
to the
active compound. However in infected cells,
HSV or VZV
coded
thymidine kinase facilitates the conversion of aciclovir to aciclovir
monophosphate, which is
then converted to aciclovir triphosphate by cellular enzymes.
Aciclovir triphosphate acts as an
_Aciclovir AN tablets Product Information _
_ _
_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 36.AN.P.1.1
Page 2
inhibitor of and substrate for the herpes specified DNA polymerase,
preventing furtherviral
DNA synthesis.
Pharmacokinetics
Aciclovir
is
only
partially
and
variably
absorbed
from
the
gut. Estimated
bioavailability
following a dose of 200mg is about 20% and decreases to about half of
this with an 800mg
dose.
Mean
steady
state
peak
and
trough
concent