LORSTAT 40 atorvastatin (as calcium) 40 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium trihydrate, Quantity: 43.376 mg (Equivalent: atorvastatin, Qty 40 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; microcrystalline cellulose; sodium carbonate; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; hyprolose; arginine; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

90, 10, 500 (for dispensing only), 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LORSTAT is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,LORSTAT is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Product summary:

Visual Identification: White, oval, biconvex, film coated tablet with break line on one side and debossed '40' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-08-18

Patient Information leaflet

LORSTAT
_Atorvastatin (as calcium trihydrate) tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LORSTAT.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LORSTAT
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LORSTAT IS
USED FOR
LORSTAT is used to treat
•
lowers high cholesterol levels
•
to reduce the risk of having a
heart attack or stroke in people
who have high blood pressure and
coronary heart disease (CHD) or
who are at risk of CHD.
Examples of risk factors for CHD
include diabetes, a history of
stroke, or small blood vessel
disease.
_WHAT IS CHOLESTEROL_
Everyone has cholesterol in their
blood. It is a type of blood fat needed
by the body for many things, such as
building cell walls, making bile acids
(which help to digest food) and some
hormones. However, too much
cholesterol can be a problem.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body makes too much
cholesterol or you have too much
cholesterol in your diet, then your
cholesterol level becomes too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
There are different types of
cholesterol. LDL, or low-density
lipoprotein, is the 'bad' cholesterol
that can block your blood vessels.
HDL, or high density lipoprotein
cholesterol is the 'good' cholesterol
that is thought to remove the 'bad'
cholesterol from the blood vessels.
When you have high levels of 'bad'
cholesterol in your blood, it may
'stick' to the inside of your blood
vessels instead of being carried to the
parts of the body where it is needed.
Over time, this can form hard areas
(called plaques) on the walls of

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LORSTAT
®
_Atorvastatin (as calcium trihydrate) tablets _
1
NAME OF THE MEDICINE
Atorvastatin calcium trihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LORSTAT contains atorvastatin (as calcium) and is available in four
strengths:
Each LORSTAT 10 tablet contains atorvastatin calcium equivalent to 10
mg atorvastatin.
Each LORSTAT 20 tablet contains atorvastatin calcium equivalent to 20
mg atorvastatin.
Each LORSTAT 40 tablet contains atorvastatin calcium equivalent to 40
mg atorvastatin.
Each LORSTAT 80 tablet contains atorvastatin calcium equivalent to 80
mg atorvastatin.
Excipients with known effect:
Contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral. Film-coated tablets.
Presentations:
LORSTAT 10 – White, oval, biconvex, film coated tablet plain on one
side and debossed ‘
10
’ on the other
side.
LORSTAT 20 – White, oval, biconvex, film coated tablet with break
line on one side and debossed ‘
20
’ on
the other side.
LORSTAT 40 – White, oval, biconvex, film coated tablet with break
line on one side and debossed ‘
40
’ on
the other side.
LORSTAT 80 - White, oval, biconvex, film coated tablet with break line
on one side and debossed ‘
80
’ on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LORSTAT is indicated as an adjunct to diet for the treatment of
patients with hypercholesterolaemia.
Prior to initiating therapy with atorvastatin, secondary causes of
hypercholesterolaemia (e.g. poorly
controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive liver
disease, other drug therapy, and alcoholism) should be identified and
treated.
LORSTAT is indicated in hypertensive patients with multiple risk
factors for coronary heart disease (CHD)
which may include diabetes, history of stroke or other cerebrovascular
disease, peripheral vascular disease
or
existing
asymptomatic
CHD
(see
section
5.1
PHARMACODYNAMIC
PROPERTIES,
CLINICAL
TRIALS