Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATORVASTATIN CALCIUM
PAHANG PHARMACY SDN. BHD.
ATORVASTATIN CALCIUM
90Tablet Tablets
KRKA
1.3.1 Atorvastatin SPC, Labeling and Package Leaflet MY-Malaysia PI_Text013189_2 - Updated: Page 1 of 12 ATORIS _Atorvastatin_ COMPOSITION Atoris film-coated tablets 10 mg Each film-coated tablet contains 10 mg of atorvastatin as atorvastatin calcium. Atoris film-coated tablets 20 mg Each film-coated tablet contains 20 mg of atorvastatin as atorvastatin calcium . Atoris film-coated tablets 40 mg Each film-coated tablet contains 40 mg of atorvastatin as atorvastatin calcium . PRODUCT DESCRIPTION 10 mg tablets: White, round, slightly convex, film-coated tablet, bevel-edged. 20 mg tablets: White, round, slightly convex, film-coated tablet, bevel-edged. 40 mg tablets: White, round, slightly convex, film-coated tablet, bevel-edged. THERAPEUTIC INDICATIONS Hypercholesterolemia Atoris is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL- cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atoris is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors. POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Atoris and should continue on this diet during treatment with Atoris. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. The usual starting dose is Read the complete document