APX-PRAVASTATIN pravastatin sodium 20 mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

pravastatin sodium, Quantity: 20 mg

זמין מ:

Arrotex Pharmaceuticals Pty Ltd

טופס פרצבטיות:

Tablet, uncoated

הרכב:

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

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

100 tablets, 3 tablets, 30 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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. APX-PRAVASTATIN 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. APX-PRAVASTATIN is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. APX-PRAVASTATIN is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS). APX-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 TRAILS).

leaflet_short:

Visual Identification: Yellow capsule shaped bi-convex tablet with a "20" engraved on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2020-06-23

עלון מידע

160517 PRAVACHOL CMI V1
Page 1 of 3
APX-PRAVASTATIN
®
_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 _APX-PRAVASTATIN _.
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
_APX-PRAVASTATIN _ and
keep it in a safe place to
refer to later.
WHAT IS IT USED FOR
_ _
_APX-PRAVASTATIN _ 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 _APX-_
_PRAVASTATIN _ 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.
_APX-PRAVASTATIN _ 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
_APX-PR

מאפייני מוצר

1 AUSTRALIAN PRODUCT INFORMATION APX-PRAVASTATIN (PRAVASTATIN SODIUM) TABLETS
1
NAME OF THE MEDICINE
APX-PRAVASTATIN (Pravastatin Sodium).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-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 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.
APX-PRAVASTATIN 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
APX-PRAVASTATIN 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.
APX-PRAVASTATIN is indicated in patients with previous myocardial
infarction including those
who have