PRAVASTATIN AN pravastatin sodium 20mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pravastatin sodium, Quantity: 20 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

pravastatin sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; iron oxide yellow; lactose monohydrate; heavy magnesium oxide; microcrystalline cellulose; povidone

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,2. Pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/L) serum cholesterol levels.,3. Pravastatin is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS).,4. Pravastatin is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (see CLINICAL TRIALS).

Product summary:

Visual Identification: Yellow, capsule shaped, biconvex, mottled uncoated tablets with notched sides at double bisect, debossed with 'R' on one side & '20' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-10-24

Patient Information leaflet

PRAVASTATIN AN
CONSUMER MEDICINE INFORMATION
Ver 1.0
Page 1 of 5
PRAVASTATIN AN
Pravastatin Sodium
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ
THIS
LEAFLET
CAREFULLY
BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about pravastatin. It does
not
contain
all
the
available
information. It does not take the place
of
talking
to
your
doctor
or
pharmacist.
ASK YOUR DOCTOR OR PHARMACIST:

if
there
is
anything
you
do
not
understand in this leaflet,

if
you
are
worried
about
taking
your medicine, or

to
obtain
the
most
up-to-date
information
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using this medicine against the
benefits they expect it will have for
you.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT PRAVASTATIN AN
IS USED FOR
The
name
of
your
medicine
is
PRAVASTATIN AN. It contains the
active ingredient, pravastatin sodium.
It is used, together with changes in
the diet, to treat:

people
who
have
high
blood
cholesterol levels

people who have had a heart attack
(even
if
their
blood
cholesterol
levels are normal)

people who have had an episode of
unstable angina
In these people pravastatin can reduce
the risk of having a stroke, reduce the
risk of further heart disease, or reduce
the possibility of needing a bypass
operation.
It is also used to treat children and
adolescent patients aged 8 years and
older who have heterozygous familial
hypercholesterolaemia
(an
inherited
disorder which produces high blood
cholesterol
levels).
This
is
in
combination
with
diet
and
lifestyle
changes.
Ask
your
doctor
if
you
have
any
questions
about
why
this
medicine
has
been
prescribed
for
you.
Your
doctor
may
have
prescribed
this
medicine for another reason.
This medicine is available only with a
doctor's prescription.
_ _
HOW IT WORKS
Pravastatin
lowers
high
blood
cholesterol
levels
(doctors
call
this
hypercholesterolaemia.
It
is
more
effective
if
it
is
taken
with
a
cholesterol lowering diet.
If you have had a heart at

Summary of Product characteristics

_Pravastatin AN tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Pravastatin AN PI v2.0
Page 1 of 21
PRAVASTATIN AN
_ _
_(PRAVASTATIN SODIUM TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of this medicine is pravastatin sodium.
CHEMICAL
NAME:
Sodium
(3
_R_
,5
_R_
)-3,5-dihydroxy-7-[(1
_S_
,2
_S_
,6
_S_
,8
_S_
,8a
_R_
)-6-hydroxy-2-methyl-
8[[(2
_S_
)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate.
MOLECULAR FORMULA:
C
23
H
35
O
7
Na
MOLECULAR WEIGHT:
446.52
CAS REGISTRY NUMBER: _[81131-70-6]_
DESCRIPTION
Pravastatin is one of a new class of lipid-lowering compounds, the
HMG-CoA reductase inhibitors,
that
reduce
cholesterol
biosynthesis.
These
agents
are
competitive inhibitors
of
3-hydroxy-3-
methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing
the early rate-limiting
step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.
Pravastatin sodium is white to yellowish white crystalline powder. It
is freely soluble in water,
methanol, glacial acetic acid & soluble in ethanol.
PRAVASTATIN AN is available as tablets containing 10, 20, 40 & 80 mg
of pravastatin
sodium.
_PRAVASTATIN AN 10_
Yellow, capsule shaped, biconvex, mottled uncoated tablets with
notched sides at double bisect,
debossed with ‘R’ on one side and ‘10’ on the other side.
_PRAVASTATIN AN 20_
Yellow, capsule shaped, biconvex, mottled uncoated tablets with
notched sides at double bisect,
debossed with ‘R’ on one side and ‘20’ on the other side.
_Pravastatin AN tablets Product Information _
_ Amneal Pharma Australia Pty Ltd _
Pravastatin AN PI v2.0
Page 2 of 21
_PRAVASTATIN AN 40_
Yellow, capsule shaped, biconvex, mottled uncoated tablets debossed
with ‘R’ on one side and ‘40’
on the other side.
_PRAVASTATIN AN 80_
Yellow, oval shaped, biconvex, mottled uncoated tablets debossed with
‘R’ on one side and ‘80’ on
the other side.
PRAVASTATIN
AN
tablets
contain
the
following
inactive
ingredients:
lactose,
povidone,
microcrystalline cellul