ATOSTAT atorvastatin (as calcium) 40mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
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Active ingredient:
atorvastatin calcium, Quantity: 41.44 mg (Equivalent: atorvastatin, Qty 40 mg)
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Atorvastatin calcium
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; povidone; methionine; magnesium stearate; crospovidone; sodium carbonate; mannitol; purified talc; titanium dioxide; hypromellose; macrogol 6000
Administration route:
Oral
Units in package:
30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
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. . Atorvastatin 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 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 tablet with "40" on one side and "A" on reverse.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2012-05-08
Summary of Product characteristics
Atostat PI Dec 2018
AUSTRALIAN PRODUCT INFORMATION – ATOSTAT® (ATORVASTATIN
CALCIUM)
1.
NAME OF THE MEDICINE
Atorvastatin calcium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATOSTAT tablets contain atorvastatin calcium equivalent to 10, 20, and
40 mg
atorvastatin. The tablets also contain the following inactive
ingredients: Mannitol,
Microcrystalline cellulose, Crospovidone, Sodium carbonate anhydrous,
Povidone,
Methionine, Magnesium stearate, Talc and Opadry 03F28446 White (ARTG
107577).
3.
PHARMACEUTICAL FORM
ATOSTAT is available in three strengths:
10 mg: white oval biconvex tablet with “10” on one side and
“A” on reverse.
20 mg: white oval biconvex tablet with “20” on one side and
“A” on reverse.
40 mg: white oval biconvex tablet with “40” on one side and
“A” on reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATOSTAT 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.
ATOSTAT 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, Prevention of Cardiovascular Disease) 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Atostat PI Dec 2018
ATOSTAT can be administered within the dosage range of 10–80 mg/day
as a single
daily dose. ATOSTAT can be taken at any time of the day, with or
without food.
Therapy should be individualised accord
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