LIPOSTAT pravastatin sodium 10mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

pravastatin sodium, Quantity: 10 mg

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

INN（国際名）:

pravastatin sodium

医薬品形態:

Tablet, uncoated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

30 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. LIPOSTAT is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. LIPOSTAT is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS). LIPOSTAT 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).

製品概要:

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

認証ステータス:

Registered

承認日:

2005-08-05

情報リーフレット

LIPOSTAT CMI
Page 1 of 4
LIPOSTAT

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
LIPOSTAT. This leaflet does
not tell you everything about
LIPOSTAT. This leaflet is no
substitute for talking with your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you taking
LIPOSTAT against the benefits
they expect it will have for
you.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT IS LIPOSTAT
USED FOR?
LIPOSTAT tablets contain
pravastatin sodium, a drug
that reduces the level of
cholesterol in your blood and
helps to protect you in other
ways from heart attack or
stroke. It is more effective if it
is taken with a diet low in fat.
LIPOSTAT 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 this medicine
can reduce the risk of further
heart disease, reduce the
possibility of needing a bypass
operation, or reduce the risk
of having a stroke.
LIPOSTAT lowers high blood
cholesterol levels. It is also
used if your cholesterol levels
are normal if you have had a
heart attack or an episode of
unstable angina.
LIPOSTAT 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.
LIPOSTAT 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

製品の特徴

1
AUSTRALIAN
PRODUCT
INFORMATION
–
LIPOSTAT
(PRAVASTATIN
SODIUM) TABLETS
1
NAME OF THE MEDICINE
Pravastatin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LIPOSTAT tablets are available in 10 mg, 20 mg, 40 mg or 80 mg of
pravastatin sodium.
Excipients with known effect: Sugars as lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
LIPOSTAT are yellow capsule shaped biconvex tablets. The 10 mg tablet
(8.8 x 4.4mm) is engraved
“10” on one side, the 20 mg tablet (11.0 x 5.5mm) is engraved
“20” on one side, the 40 mg tablet (14.0
x 7.0mm) is engraved “40” on one side, the 80 mg tablet (17.6 x
8.8mm) is engraved “80” on one side.
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.
LIPOSTAT is indicated in patients with previous myocardial infarction
including those who
have normal (4.0 – 5.5 mmol/L) serum cholesterol levels.
3.
LIPOSTAT
is
indicated
in
patients
with
unstable
angina
pectoris
(see
section
5.1
PHARMACODYNAMIC PROPERTIES – Clinical Trials).
4.
LIPOSTAT 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 section 5.1 PHARMACODYNAMIC PROPERTIES –
Clinical Trials).
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Prior to initiating LIPOSTAT (pravastatin sodium), the patient should
be placed on a standard
cholesterol-lowering diet (AHA Phase 1 or NCEP Step 1) for a maximum
of 3 to 6 months, depending
upon the severity of the lipid elevation. Dietary therapy should be
continued during treatment.
ADULT PATIENTS
The
recommended
starting
dose
is
10
to
20
mg
o