Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 86.8 mg
Medis Pharma Pty Ltd
atorvastatin calcium trihydrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; povidone; microcrystalline cellulose; glycerol dibehenate; crospovidone; sodium carbonate; titanium dioxide; hypromellose; macrogol 6000
Oral
10, 30
(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. ,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.
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
Licence status A
2014-10-24
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 Прочитајте комплетан документ