CRESTAT rosuvastatin (as calcium) 10 mg tablets blister

Active ingredient:

rosuvastatin calcium, Quantity: 10.4 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; polyvinyl alcohol; crospovidone; purified talc; xanthan gum; calcium hydrogen phosphate; titanium dioxide; microcrystalline cellulose; lecithin; magnesium stearate

Administration route:

Oral

Units in package:

7, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of Cardiovascular Events,Rosuvastatin is indicated for prevention of major cardiovascular events in men = 50 years old and women = 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease).,Rosuvastatin is indicated to:,? Reduce the risk of nonfatal myocardial infarction,? Reduce the risk of nonfatal stroke,? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia,Rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,Prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Product summary:

Visual Identification: White, round, biconvex tablets, debossed with "R9UN 10" on one side and on the other side scored.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2012-05-14