AURO-PRAVASTATIN 80 pravastatin sodium 80mg tablet bottle

Active ingredient:

pravastatin sodium, Quantity: 80 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

pravastatin sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: povidone; microcrystalline cellulose; lactose monohydrate; heavy magnesium oxide; croscarmellose sodium; magnesium stearate; iron oxide yellow

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,2. Pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/L) serum cholesterol levels.,3. Pravastatin is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS).,4. Pravastatin is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (see CLINICAL TRIALS).

Product summary:

Visual Identification: Yellow, oval shaped, biconvex, mottled uncoated tablets debossed with 'R' on one side and '80' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-10-24