ATORVASTATIN-ZAZ 80 atorvastatin (as calcium trihydrate) 80 mg film-coated tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

atorvastatin calcium trihydrate, Quantity: 86.8 mg

から入手可能:

Medis Pharma Pty Ltd

INN（国際名）:

atorvastatin calcium trihydrate

医薬品形態:

Tablet, film coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

10, 30

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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.

製品概要:

Visual Identification: oval, white, biconvex tablet, embossed with '80' on one side and A on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2014-10-24

製品の特徴

Atorvastatin-ZAZ – Product information
Page 1 of 20
PI V5 Dec 2018
AUSTRALIAN PRODUCT INFORMATION – ATORVASTATIN-ZAZ (ATORVASTATIN
CALCIUM)
1.
NAME OF THE MEDICINE
Atorvastatin Calcium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATORVASTATIN-ZAZ 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-ZAZ 10_
Atorvastatin (as calcium) 10 mg; oval, white, biconvex tablet,
embossed with ‘10’ on one side and A on the other side.
_ATORVASTATIN-ZAZ 20_
Atorvastatin (as calcium) 20 mg; oval, white, biconvex tablet,
embossed with ‘20’ on one side and A on the other side.
_ATORVASTATIN-ZAZ 40_
Atorvastatin (as calcium) 40 mg; oval, white, biconvex tablet,
embossed with ‘40’ on one side and A on the other side.
_ATORVASTATIN-ZAZ 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 PROPERTIE