ROSUVASTATIN GPPL rosuvastatin (as calcium) 20mg tablet bottle

Active ingredient:

rosuvastatin calcium, Quantity: 20.8 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; crospovidone; titanium dioxide; hypromellose; sunset yellow FCF aluminium lake; triacetin; allura red AC aluminium lake; indigo carmine aluminium lake; iron oxide red

Administration route:

Oral

Units in package:

500, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROSUVASTATIN GPPL should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Cardiovascular Events: ROSUVASTATIN GPPL is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 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 GPPL 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 GPPL is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with ROSUVASTATIN GPPL, 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: Pink, round, biconvex, coated tablet, debossed with 'ROS' over '20' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-02-02