PRAVASTATIN-DRLA pravastatin sodium 80mg tablet bottle

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

pravastatin sodium, Quantity: 80 mg

متاح من:

Dr Reddys Laboratories Australia Pty Ltd

INN (الاسم الدولي):

pravastatin sodium

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; meglumine; crospovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 8000; purified talc

طريقة التعاطي:

Oral

الوحدات في الحزمة:

30 tablet, 100 tablet, 500 tablet, 90 tablet

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

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, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Pravastatin-DRLA is indicated in patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. Pravastatin-DRLA is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS). Pravastatin-DRLA 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).

ملخص المنتج:

Visual Identification: White, round, biconvex, coated tablets debossed "RDY" on one side and "274" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2010-10-28

نشرة المعلومات

Pravastatin-DRLA: CMI, V3, 10Nov10
Page 1 of 3
PRAVASTATIN-DRLA
_Pravastatin sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This medicine your doctor has
prescribed for you is called
Pravastatin-DRLA. The information
in this leaflet will answer some of the
questions you may have about
Pravastatin-DRLA. This leaflet does
not tell you everything about
Pravastatin-DRLA. 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. This
information is not intended to replace
your doctor's advice.
You should read this leaflet carefully
before starting Pravastatin-DRLA
and keep it in a safe place to refer to
later.
WHAT PRAVASTATIN-
DRLA IS USED FOR
Pravastatin-DRLA 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 Pravastatin-DRLA can
reduce the risk of further heart
disease, reduce the possibility of
needing a bypass operation, or reduce
the risk of having a stroke.
Pravastatin-DRLA 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.
Pravastatin-DRLA 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.
Pravastatin-DRLA may be used to
lower lipids in heart or kidney
transplant patients, who are also
being given immunosuppressive
medicine.
Pravast

خصائص المنتج

Product Information
Page 1 of 16
PRAVASTATIN–DRLA TABLETS
NAME OF THE MEDICINE
_Pravastatin Sodium _
Chemical name:
Sodium (3R,5R)-3,5-dihydroxy-7[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-
[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate
Molecular formula:
C
23
H
35
NaO
7
CAS number:
81131-70-6
Molecular weight:
446.5
Structural formula:
CH
3
H
OH
H
COONa
H
OH
H
HO
H
O
O
CH
3
H
H
3
C
H
H
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 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.
Pravastatin-DRLA tablets contain the following inactive ingredients:
lactose, cellulose - microcrystalline,
croscarmellose sodium, meglumine, crospovidone magnesium stearate,
Opadry White YS- 1-7040.
PHARMACOLOGY
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-C), low density
lipoprotein cholesterol (LDL-C) and apolipoprotein B ( a membrane
transport complex for LDL) promote
human athero