ATORVASTATIN ACTAVIS 10 atorvastatin (as calcium) 10 mg film-coated tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

atorvastatin calcium, Quantity: 10.36 mg (Equivalent: atorvastatin, Qty 10 mg)

可用日期:

Medis Pharma Pty Ltd

INN（国际名称）:

Atorvastatin calcium

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: crospovidone; sodium carbonate; methionine; povidone; mannitol; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 6000

给药途径:

Oral

每包单位数:

10, 30

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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.

產品總結:

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

授权状态:

Licence status A

授权日期:

2012-08-03

产品特点

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