国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
atorvastatin calcium trihydrate, Quantity: 43.376 mg (Equivalent: atorvastatin, Qty 40 mg)
Alphapharm Pty Ltd
atorvastatin calcium trihydrate
Tablet, film coated
Excipient Ingredients: lactose; microcrystalline cellulose; sodium carbonate; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; hyprolose; arginine; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin
Oral
500 (for dispensing only), 10, 90, 30
(S4) Prescription Only Medicine
LORSTAT 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.,LORSTAT 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) 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: White, oval, biconvex, film coated tablet with break line on one side and debossed '40' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2012-07-11
AUSTRALIAN PRODUCT INFORMATION LORSTAT ® _Atorvastatin (as calcium trihydrate) tablets _ 1 NAME OF THE MEDICINE Atorvastatin calcium trihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LORSTAT contains atorvastatin (as calcium) and is available in four strengths: Each LORSTAT 10 tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin. Each LORSTAT 20 tablet contains atorvastatin calcium equivalent to 20 mg atorvastatin. Each LORSTAT 40 tablet contains atorvastatin calcium equivalent to 40 mg atorvastatin. Each LORSTAT 80 tablet contains atorvastatin calcium equivalent to 80 mg atorvastatin. Excipients with known effect: Contains sugars (as lactose) and soya bean products. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Oral. Film-coated tablets. Presentations: LORSTAT 10 – White, oval, biconvex, film coated tablet plain on one side and debossed ‘ 10 ’ on the other side. LORSTAT 20 – White, oval, biconvex, film coated tablet with break line on one side and debossed ‘ 20 ’ on the other side. LORSTAT 40 – White, oval, biconvex, film coated tablet with break line on one side and debossed ‘ 40 ’ on the other side. LORSTAT 80 - White, oval, biconvex, film coated tablet with break line on one side and debossed ‘ 80 ’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LORSTAT 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. LORSTAT 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 section 5.1 PHARMACODYNAMIC PROPE 完全なドキュメントを読む