Šalis: Australija
kalba: anglų
Šaltinis: 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: sodium carbonate; povidone; microcrystalline cellulose; glycerol dibehenate; magnesium stearate; 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. ,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-ZP – Product information Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – ATORVASTATIN-ZP (ATORVASTATIN CALCIUM) 1. NAME OF THE MEDICINE Atorvastatin Calcium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ATORVASTATIN-ZP tablets contain 80 mg of atorvastatin (calcium). The 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 (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 PROPERTIES, CLINICAL TRIALS, PREVENTION OF CARDIOVASCULAR DISEASE) to reduce the risk of nonfatal MI 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage and administration atorvastatin can be administered within the dosage range of 10 to 80 mg/day as a single daily dose. Atorvastatin can be taken at any time of the day, with or without food. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy and the patient's response. After initiation and/or upon titration of atorvastatin, lipid levels should be reanalysed wit Perskaitykite visą dokumentą