Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2021 Publisher: Lupin Australia Pty Ltd, Suite 2, Level 2, 19-23 Prospect Street, Box Hill, VIC, 3128 Distributor: Arrotex Pharmaceuticals Pty Ltd, 15-17 Chapel Street, Cremorne, VIC, 3121, Australia
Ezetimibe.
Atorvastatin (as calcium trihydrate).
| Pharmaceutical Form |
|---|
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EZETAST 10/10: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘1’ on the other side. EZETAST 10/20: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘2’ on the other side. EZETAST 10/40: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘3’ on the other side. EZETAST 10/80: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with ‘AE’ on one side and ‘4’ on the other side. |
EZETAST is a film-coated tablet containing ezetimibe 10 mg and atorvastatin 10, 20, 40 or 80 mg.
EZETAST 10/10: Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 10 mg of atorvastatin.
EZETAST 10/20: Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 20 mg of atorvastatin.
EZETAST 10/40: Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 40 mg of atorvastatin.
EZETAST 10/80: Each tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 80 mg of atorvastatin.
Excipients with known effect: contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.
Ezetimibe is a white to off-white, crystalline powder that is freely soluble in acetonitrile, insoluble in aqueous solvents and non-polar solvents like hexane.
Chemical Name: 1-(4-fluorophenyl)3==®==[3-(4-fluorophenyl)-3(S)hydroxypropyl]4(S)(4-hydroxyphenyl)-2-azetidinone
Molecular Formula: C24H21F2NO3
Molecular Weight: 409.43
Atorvastatin calcium trihydrate is a white to off-white crystalline powder that is sparingly soluble in methanol.
Chemical Name: [R-(R*,R*)]2(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl4[(phenylamino) carbonyl]-1H-pyrrole -1-heptanoic acid, calcium salt (2:1) trihydrate
Molecular Formula: C66H68CaF2N4O10.3H2O
Molecular Weight: 1209.42
Ezetimibe: 163222-33-1
Atorvastatin: 344423-98-9
| Active Ingredient | Description | |
|---|---|---|
| Atorvastatin |
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. |
|
| Ezetimibe |
Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol. The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of cholesterol. |
| List of Excipients |
|---|
|
Each film-coated tablet of EZETAST contains the following inactive ingredients: Povidone, sodium lauryl sulfate, lactose monohydrate, crospovidone, colloidal anhydrous silica, sodium stearylfumarate, microcrystalline cellulose, lactose, calcium carbonate, hyprolose and Opadry AMB complete film coating system OY-B-28920 White (ARTG No 4271). The film coating contains: Polyvinyl Alcohol, Titanium Dioxide, Talc, Lecithin and Xanthan Gum. |
EZETAST tablets are packed in blisters of Cold form Alu-Alu as forming (base) material and 0.025 hard tampered heat-sealed lacquer coated plain Aluminium foil as the lidding material.
Available as 30 tablet blister (aluminium/aluminium) packs.
Lupin Australia Pty Ltd, Suite 2, Level 2, 19-23 Prospect Street, Box Hill, VIC, 3128
Distributor: Arrotex Pharmaceuticals Pty Ltd, 15-17 Chapel Street, Cremorne, VIC, 3121, Australia
Australian Registration Numbers:
EZETAST 10/10: AUST R 306963
EZETAST 10/20: AUST R 306966
EZETAST 10/40: AUST R 306958
EZETAST 10/80: AUST R 306956
Date of first approval: 01 November 2019
| Drug | Countries | |
|---|---|---|
| EZETAST | Australia |
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