BANSEP

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

atorvastatin calcium, Quantity: 10.36 mg (Equivalent: atorvastatin, Qty 10 mg)

MAH:

Sun Pharma ANZ Pty Ltd

INN:

Atorvastatin calcium

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: sodium carbonate; butylated hydroxytoluene; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; lactose; hyprolose; sodium lauryl sulfate; butylated hydroxyanisole; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

administration_route:

Oral

units_in_package:

100 tablets per pack, 28 tablets per pack, 30 tablets per pack

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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.

leaflet_short:

Visual Identification: White to off-white, film-coated, oval tablets debossed with "AT1" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

authorization_status:

Licence status A

authorization_date:

2011-08-22