ATORVASTATIN RAN atorvastatin (as calcium trihydrate) 80 mg tablets bottle

Active ingredient:

atorvastatin calcium trihydrate, Quantity: 86.76 mg (Equivalent: atorvastatin, Qty 80 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

atorvastatin calcium trihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium carbonate; microcrystalline cellulose; polysorbate 80; croscarmellose sodium; hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; macrogol 8000; hypromellose; purified talc; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate

Administration route:

Oral

Units in package:

28, 100, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.,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.

Product summary:

Visual Identification: White to off-white, elliptical, film-coated tablets debossed 'AS80' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-09-23