VALACICLOVIR AMNEAL valaciclovir hydrochloride 500mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride monohydrate, Quantity: 611.7 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Valaciclovir hydrochloride monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; povidone; magnesium stearate; titanium dioxide; hypromellose; hyprolose; macrogol 400

Administration route:

Oral

Units in package:

40 tablets, 30 tablets, 28 tablets, 20 tablets, 10 tablets, 42 tablets, 50 tablets, 14 tablets, 100 tablets, 56 tablets, 90 tablets, 112 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. For the treatment of opthalmic zoster. For the treatment of recurrent herpes labialis (cold sores). For the treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes. Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Vaciclor, it is recommended that patients use safer sex practices (See Precautions). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Product summary:

Visual Identification: Oval, white, biconvex, 8.8 x 17.6 mm with VC2 on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-05-18

Patient Information leaflet

VALACICLOVIR AMNEAL/141114/CMI-3
1
VALACICLOVIR AMNEAL
TREATMENT OF ZOSTER AND HERPES LABIALIS
contains the active ingredient valaciclovir (hydrochloride)
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about VALACICLOVIR
AMNEAL.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking VALACICLOVIR
AMNEAL against the benefits they
expect it will 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 VALACICLOVIR
AMNEAL is used for
VALACICLOVIR AMNEAL is used to
treat shingles (herpes zoster),
ophthalmic zoster (shingles
affecting the eye region) and cold
sores (herpes labialis).
VALACICLOVIR AMNEAL belongs to
a group of medicines called
antivirals.
It works by stopping the
multiplication of the virus which
causes the shingles and cold sores.
VALACICLOVIR AMNEAL reduces
the length and severity of an
outbreak and the duration of pain
associated with the shingles and
cold sores.
It is important to start treatment
within three days of the shingles
attack.
For treatment of cold sores the
tablets should be taken at the
earliest symptom of a cold sore
(e.g. tingling, itching, or burning).
VALACICLOVIR AMNEAL tablets are
more effective in patients 50 years
and over.
Your doctor may have prescribed
VALACICLOVIR AMNEAL for another
reason. Ask your doctor if you have
any questions about why
VALACICLOVIR AMNEAL has been
prescribed for you.
VALACICLOVIR AMNEAL is not
recommended for use in children,
as there have been no studies of its
effects in children.
VALACICLOVIR AMNEAL is available
only with a doctor’s prescription.
There is no evidence that
VALACICLOVIR AMNEAL is
addictive.
Before you take
VALACICLOVIR AMNEAL
When you must not take it
DO NOT TAKE VALACICLOVIR
AMNEAL IF YOU ARE ALLERGIC TO
MEDICINES C

Summary of Product characteristics

Valaciclovir AMNEAL PI v0.1
Valaciclovir AMNEAL
PRODUCT INFORMATION
NAME OF THE MEDICINE
Valaciclovir is the L-valine ester of aciclovir. The chemical name for
valaciclovir is 2-[(2-amino-
1,6-dihydro-6-oxo-9_H_-purin-9-yl)methoxy]ethyl
L
-valinate hydrochloride. Aciclovir is a purine
nucleoside analogue. Its structural formula is:
C
13
H
20
N
6
O
4
.HCl
Molecular weight: 360.8
CAS No.: 124832-27-5
DESCRIPTION
Valaciclovir AMNEAL tablets come in three strengths and contain either
250 mg, 500 mg or
1000 mg of valaciclovir. The tablets also contain microcrystalline
cellulose, povidone, magnesium
state and Opadry white Y-5-7068 (ARTG No. 11771). The tablets are
gluten free.
PHARMACOLOGY
Valaciclovir is rapidly and almost completely converted in man to
aciclovir probably by the
enzyme valaciclovir hydrolase. Aciclovir is a specific inhibitor of
the herpes viruses with _in vitro _
activity against herpes simplex viruses (HSV) type 1 and type 2 (IC
50
0.1 –3.0μM), varicella-zoster
virus (VZV) (IC
50
1.6 – 5.1μM) and human cytomegalovirus (HCMV) (IC
50
10 - > 200μM). Aciclovir
inhibits herpes virus DNA synthesis once it has been phosphorylated to
the active triphosphate
form. The first stage of phosphorylation requires the activity of a
virus-specific enzyme:
thymidine kinase in HSV and VZV infected cells or protein kinase in
HCMV infected cells. This
requirement for activation of aciclovir by a virus specific enzyme
largely explains its unique
selectivity.
The phosphorylation process is completed (conversion from mono- to
triphosphate) by cellular
kinases. Aciclovir triphosphate competitively inhibits the virus DNA
polymerase and incorporation
of this nucleoside analogue results in obligate chain termination,
halting virus DNA synthesis and
thus blocking virus replication.
VALACICLOVIR AMNEAL – Product information
Page 2 of 21
Valaciclovir AMNEAL PI v0.1
PHARMACODYNAMICS/RESISTANCE DEVELOPMENT
Resistance to aciclovir is normally due to a thymidine kinase
deficient phenotype. In animal
models, the viral fitness