ATORVASTATIN-GX atorvastatin (as calcium trihydrate) 80 mg film-coated tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
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Active ingredient:
atorvastatin calcium trihydrate, Quantity: 86.8 mg
Available from:
Medis Pharma Pty Ltd
INN (International Name):
atorvastatin calcium trihydrate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; sodium carbonate; glycerol dibehenate; povidone; crospovidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000
Administration route:
Oral
Units in package:
100, 90
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Atorvastatin 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. ,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 (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.
Product summary:
Visual Identification: oval, white, biconvex tablet, embossed with '80' on one side and A on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-10-24
Summary of Product characteristics
Atorvastatin-Gx – Product information
Page 1 of 20
Atorvastatin-GX PI V3
AUSTRALIAN PRODUCT INFORMATION – ATORVASTATIN GX (ATORVASTATIN
CALCIUM)
1.
NAME OF THE MEDICINE
Atorvastatin Calcium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATORVASTATIN-GX tablets contain 80 mg of atorvastatin (calcium). The
tablets also contain
microcrystalline
cellulose,
crospovidone,
sodium
carbonate
anhydrous,
povidone,
glycerol
dibehenate, magnesium stearate and Opadry white 03F28446 (107577). The
tablets are gluten
free.
3.
PHARMACEUTICAL FORM
_ATORVASTATIN-GX 80_
Atorvastatin (as calcium) 80 mg; oval, white, biconvex tablet,
embossed with ‘80’ on one side and A on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atorvastatin
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.
Hypertensive patients with multiple risk factors for 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,
PREVENTION OF CARDIOVASCULAR
DISEASE) to reduce the risk of nonfatal MI and nonfatal 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
Dosage and administration atorvastatin can be administered within the
dosage range of 10 to
80 mg/day as a single daily dose. Atorvastatin can be taken at any
time of the day, with or
without food. Therapy should be individualised according to the target
lipid levels, the
recommended goal of therapy and the patient's response. After
initiation and/or upon titration
of atorvas
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