ATORVASTATIN ACTAVIS 10 atorvastatin (as calcium) 10 mg film-coated 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
Send request.
Active ingredient:
atorvastatin calcium, Quantity: 10.36 mg (Equivalent: atorvastatin, Qty 10 mg)
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Atorvastatin calcium
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: crospovidone; sodium carbonate; methionine; povidone; mannitol; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 6000
Administration route:
Oral
Units in package:
10, 30
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.,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 nonfatal myocardial infarction 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.
Product summary:
Visual Identification: oval, white, biconvex tablet, embossed with 10 on one side and A on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2012-08-03
Summary of Product characteristics
Atorvastatin Actavis – Product information
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION - ATORVASTATIN ACTAVIS
(ATORVASTATIN CALCIUM)
1.
NAME OF THE MEDICINE
Atorvastatin Calcium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATORVASTATIN ACTAVIS tablets come in four strengths and contain 10 mg,
20 mg, 40 mg or 80 mg
of atorvastatin (calcium). The 10 mg, 20 mg and 40 mg tablets also
contain: mannitol,
microcrystalline cellulose, crospovidone, sodium carbonate anhydrous,
povidone, methionine,
magnesium
stearate,
Opadry
White
03F28466
(107577).
The
80
mg
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 ACTAVIS 10_
Atorvastatin (as calcium) 10 mg; oval, white, biconvex tablet,
embossed with ‘10’ on one side and A on the other side.
_ATORVASTATIN ACTAVIS 20_
Atorvastatin (as calcium) 20 mg; oval, white, biconvex tablet,
embossed with ‘20’ on one side and A on the other side.
_ATORVASTATIN ACTAVIS 40_
Atorvastatin (as calcium) 40 mg; oval, white, biconvex tablet,
embossed with ‘40’ on one side and A on the other side. .
_ATORVASTATIN ACTAVIS 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 PHARMACODYNA
Read the complete document
