PRAVACHOL pravastatin sodium 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pravastatin sodium, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

100 tablets, 30 tablets, 3 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

As an adjunct to diet for the treatment of hypercholesterolemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. PRAVACHOL is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see CLINICAL TRIALS). INDICATIONS AS AT 23 JANUARY 2004: As an adjunct to diet for the treatment of hypercholesterolemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. PRAVACHOL is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. PRAVACHOL is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS). PRAVACHOL 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 TRAILS).

Product summary:

Visual Identification: Yellow capsule shaped bi-convex tablet with a "10" engraved on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-03-06

Patient Information leaflet

160517 PRAVACHOL CMI V1
Page 1 of 3
PRAVACHOL
®
_pravastatin sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
The information in this
leaflet will answer some of
the questions you may have
about _PRAVACHOL_. This
leaflet does not tell you
everything about the
medicine.
Your doctor and pharmacist
have been provided with full
information and can answer
any questions you may
have.
This leaflet is no substitute
for talking with your doctor
or pharmacist. You should
follow all advice from your
doctor when being treated
with this medicine.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE
ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
You should read this leaflet
carefully before starting
_PRAVACHOL_ and keep it in
a safe place to refer to later.
WHAT IS IT USED FOR
_ _
_PRAVACHOL_ is used to
treat people who have had a
heart attack or an episode
of unstable angina, or who
have high blood cholesterol
levels. In these people
_PRAVACHOL_ can reduce
the risk of further heart
disease, reduce the
possibility of needing a
bypass operation, or reduce
the risk of having a stroke.
_ _
It lowers high blood
cholesterol levels (Doctors
call this
hypercholesterolaemia). It is
also used if your cholesterol
levels are normal if you
have had a heart attack or
an episode of unstable
angina.
It is used to treat
heterozygous familial
hypercholesterolaemia in
children and adolescent
patients aged 8 years and
older as an adjunct to diet
and lifestyle changes.
If you have had a heart
attack, an episode of
unstable angina or you have
too much cholesterol in your
blood, then you have an
increased risk of a blood
clot forming in your blood
vessels and causing a
blockage. Blood vessels
that become blocked in this
way can lead to further
heart disease, angina or
stroke.
_PRAVACHOL_ may be used
to lower lipids in heart or
kidney transplant patients,
who are also being given
immunosuppressive
medicine.
It is used to treat long-term
(chronic) conditions so it is
important that you take your
_PRAVACHOL_ every day.
It is not addictive or habit

Summary of Product characteristics

1 AUSTRALIAN PRODUCT INFORMATION PRAVACHOL (PRAVASTATIN SODIUM) TABLETS
1
NAME OF THE MEDICINE
PRAVACHOL (Pravastatin Sodium).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRAVACHOL 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 an odourless, white to off-white, fine or
crystalline powder. It is a relatively
polar hydrophilic compound with a partition coefficient
(octanol/water) of 0.59 at a pH of 7.0. It is
soluble in methanol and water (>300 mg/mL), slightly soluble in
isopropanol, and practically insoluble
in acetone, acetonitrile, chloroform, and ether.
PRAVACHOL tablets are available in 10mg, 20mg, 40mg and 80mg.
Excipients of known effect: lactose.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PRAVACHOL is available as yellow capsule shaped biconvex tablets
containing 10mg, 20mg, 40mg or
80mg pravastatin sodium. The 10mg tablet (8.8 x 4.4mm) is engraved
“10” on one side, the 20mg
tablet (11.0 x 5.5mm) is engraved “20” on one side, the 40mg
tablet (14.0 x 7.0mm) is engraved “40”
on one side, the 80mg tablet (17.6 x 8.8mm) is engraved “80” on
one side. The tablets are supplied
in blister packs containing 30 tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
2.
PRAVACHOL is indicated in patients with previous myocardial infarction
including those who
have normal (4.0 – 5.5 mmol/L) serum c