CHOLVASTIN pravastatin sodium 40 mg tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

pravastatin sodium, Quantity: 40 mg

Mevcut itibaren:

Sun Pharma ANZ Pty Ltd

INN (International Adı):

pravastatin sodium

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: lactose; sodium stearylfumarate; iron oxide yellow

Uygulama yolu:

Oral

Paketteki üniteler:

30 tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

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. CHOLVASTIN is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. 3. CHOLVASTIN is indicated in patients with unstable angina pectoris see Clinical Trials). 4. CHOLVASTIN is also indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 Years of age or older (see Clinical Trials). 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. VASTORAN is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/L) serum cholesterol levels. 3. VASTORAN is indicated in patients with unstable angina pectoris see Clinical Trials). 4. VASTORAN is also indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 Years of age or older (see Clinical Trials).

Ürün özeti:

Visual Identification: Dark yellow to yellow coloured, mottled, circular, biconvex, uncoated tablet debossed with P3 on one side and a breakline on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2007-08-07

Bilgilendirme broşürü

CHOLVASTIN CMI V1 May 2011
Page 1 of 9
CHOLVASTIN TABLETS
_PRAVASTATIN SODIUM_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CHOLVASTIN
(Pravastatin Sodium).
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
CHOLVASTIN
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT CHOLVASTIN TABLETS ARE USED FOR
CHOLVASTIN
tablets
belong to a group of lipid-lowering medicines called
HMG-CoA reductase inhibitors (commonly known as "statins"). They work
by lowering lipids (fats) such as cholesterol and triglycerides in
your
blood when non-medicinal measures, such as a low-fat diet, exercise
and
lifestyle changes, alone have failed.
Cholesterol is a naturally occurring substance in the body necessary
for normal growth. However, if there is too much cholesterol in your
blood, it can get deposited along the walls of the blood vessels
leading
to
narrowing
and
even
blocking
of
these
vessels
(atherosclerosis). This is one of the common causes of heart problems
such as chest pain (angina) and heart attack (myocardial infarction).
High cholesterol levels have been shown to be associated with
increased
risk of heart disease. Other factors including high blood pressure,
high blood sugar (diabetes), increased weight, lack of exercise and
smoking further add to the risk of heart disease. High cholesterol
levels in the blood can be brought down and kept down with dietary
modifications, exercise and medicines.
CHOLVASTIN
tablets are used for one or more of the following:

If you already have heart disease and raised levels of cholesterol,
pravastatin will help reduce your chances of having another heart
attack, or a stroke. It will reduce your chances of requiring a

Ürün özellikleri

CHOLVASTIN PI V2
Page 1 of 21
CHOLVASTIN
(
PRAVASTATIN SODIUM TABLETS
)
NAME OF THE MEDICINE
Pravastatin Sodium (JAN, USAN, INN).
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.
CHOLVASTIN
tablets contain pravastatin sodium, which is chemically designated as:
_ _
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.
Its structure is:
Molecular Formula: C
23
H
35
NaO
7
Molecular Weight: 446.52
Pravastatin
Sodium
is
a
white
to
yellowish-white
powder
or
crystalline
powder,
hygroscopic. It is freely soluble in water and in methanol, soluble in
ethanol.
CHOLVASTIN
tablets contain the following inactive ingredients: lactose anhydrous,
sodium stearyl fumarate, ferric oxide yellow.
PHARMACOLOGY

MECHANISM OF ACTION
Pravastatin produces its lipid-lowering effect in two ways. First, as
a consequence of its
reversible inhibition of HMG-CoA reductase activity, it affects modest
reductions in
intracellular pools of cholesterol. This results in an increase in the
number of LDL-
receptors on cell surfaces and enhanced receptor-mediated catabolism
and clearance of
circulating LDL. Second, pravastatin inhibits LDL production by
inhibiting hepatic
synthesis of VLDL, the LDL precursor.
Clinical and pathologic studies have shown that elevated levels of
total cholesterol (Total-
CHOLVASTIN PI V2
Page 2 of 21
C), low density lipoprotein cholesterol (LDL-C) and apolipoprotein B
(a membrane
transport complex for LDL) promote human atherosclerosis. Similarly
decreased levels of
HDL-cholesterol (HDL-C) and its transport complex, apolipoprotein A,
are associated
with the development of atheroscler