PRAVASTATIN-LUPIN pravastatin sodium 40 mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

pravastatin sodium, Quantity: 40 mg

Saatavilla:

Lupin Australia Pty Limited

INN (Kansainvälinen yleisnimi):

pravastatin sodium

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow

Antoreitti:

Oral

Kpl paketissa:

30 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with Pravastatin-Lupin, 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. Pravastatin-Lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/L) serum cholesterol levels. 3. Pravastatin-Lupin is indicated in patients with unstable angina pectoris (see Clinical Trials). 4. Pravastatin-Lupin 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).

Tuoteyhteenveto:

Visual Identification: yellow coloured, capsule shaped, biconvex, film coated tablets debossed with '40' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2008-07-07

Pakkausseloste

PRAVASTATIN LUPIN
®
Pravastatin sodium
CONSUMER MEDICINE
INFORMATION
This medicine your doctor has prescribed for
you is called _PRAVASTATIN LUPIN_. The
information in this leaflet will answer some of
the questions you may have about
_PRAVASTATIN LUPIN_.
This leaflet does not tell you everything
about _PRAVASTATIN LUPIN_. 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 LUPIN _and keep it
in a safe place to refer to later.
WHAT IS PRAVASTATIN LUPIN USED
FOR?
_PRAVASTATIN LUPIN _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 LUPIN _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 LUPIN _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 LUPIN _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 LUPIN _may be used to
lower lipids in heart or kidney transplant
patients, who are also being given
immunosuppressive medicine.
_PRAVASTATIN LUPIN _is used to treat long-
term (

Valmisteyhteenveto

PRAVASTATIN-LUPIN TABLETS
NAME OF THE MEDICINE:
PRAVASTATIN SODIUM
EMPIRICAL FORMULA: C
23
H
35
NaO
7
MOLECULAR WEIGHT: 446.52
CAS: 81131-70-6.
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 is designated chemically as:_ _(3_R_, 5_R_)-7-[(1_S_,
2_S_, 6_S_, 8_S_, 8a_R_)-1, 2, 6, 7, 8,
8a-Hexahydro-6-hydroxy-2-methyl-
8-[(_S_)-2- methylbutyryloxy-1-naphthyl]]-3, 5-dihydroxyheptanoic
acid, sodium salt.
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-Lupin tablets contain the following inactive ingredients:
lactose, crospovidone, sodium bicarbonate, silica -
colloidal anhydrous, magnesium stearate, Opadry 03F52262 yellow,
water-purified.
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 atherosclerosis.
Similarly decreased levels of HDL-chole