LORSTAT 40 atorvastatin (as calcium) 40 mg tablets bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
14-11-2017
Send request.
Active ingredient:
atorvastatin calcium trihydrate, Quantity: 43.376 mg (Equivalent: atorvastatin, Qty 40 mg)
Available from:
Alphapharm Pty Ltd
INN (International Name):
atorvastatin calcium trihydrate
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; xanthan gum; polyvinyl alcohol; lecithin
Administration route:
Oral
Units in package:
500 (for dispensing only), 10, 90, 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 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:
2012-07-11
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) and soya bean products.
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
PROPE
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