البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium, Quantity: 41.44 mg (Equivalent: atorvastatin, Qty 40 mg)
Medis Pharma Pty Ltd
Atorvastatin calcium
Tablet, film coated
Excipient Ingredients: magnesium stearate; sodium carbonate; methionine; povidone; microcrystalline cellulose; mannitol; crospovidone; titanium dioxide; hypromellose; macrogol 6000
Oral
30, 10
(S4) Prescription Only Medicine
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.
Visual Identification: oval, white, biconvex tablet, embossed with 40 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
Licence status A
2012-08-03
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 اقرأ الوثيقة كاملة