Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
ATOZET 10 mg/10 mg film-coated tablets.
ATOZET 10 mg/20 mg film-coated tablets.
ATOZET 10 mg/40 mg film-coated tablets.
ATOZET 10 mg/80 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. 10 mg/10 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 12.74 mm x 5.10 mm, “257” debossed on one side. 10 mg/20 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 14.48 mm x 5.79 mm, “333” debossed on one side. 10 mg/40 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated size 16.38 mm x 6.27 mm, “337” debossed on one side. 10 mg/80 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 19.05 mm x 7.94 mm, “357” debossed on one side. |
Each film-coated tablet contains 10 mg of ezetimibe and 10, 20, 40 or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
Excipient(s) with known effect:
Each 10 mg/10 mg film-coated tablet contains 153 mg of lactose.
Each 10 mg/20 mg film-coated tablet contains 179 mg of lactose.
Each 10 mg/40 mg film-coated tablet contains 230 mg of lactose.
Each 10 mg/80 mg film-coated tablet contains 334 mg of lactose.
For the full list of excipients, see section 6.1.
| 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. |
|
| Atorvastatin and Ezetimibe |
Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Ezetimibe and atorvastatin are two lipid-lowering compounds with complementary mechanisms of action. Ezetimibe/atorvastatin combination reduces elevated total cholesterol (total-C), LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and increases high-density lipoprotein cholesterol (HDL-C) through dual inhibition of cholesterol absorption and synthesis. |
|
| 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 |
|---|
|
Tablet core: Ezetimibe Layer: Croscarmellose sodium Atorvastatin Layer: Cellulose, microcrystalline Film coating: Hypromellose |
ATOZET 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg:
Packs of 10, 30, 90, and 100 film-coated tablets in nitrogen-purged aluminium/aluminium (oPA-AlPVC cavity with Al lidding) blisters.
Packs of 30 × 1 and 45 × 1 film-coated tablets in unit dose nitrogen-purged aluminium/aluminium (oPA-Al-PVC cavity with Al lidding) blisters.
Not all pack sizes may be marketed.
N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
ATOZET 10 mg/10 mg MA031/02401
ATOZET 10 mg/20 mg MA031/02402
ATOZET 10 mg/40 mg MA031/02403
ATOZET 10 mg/80 mg MA031/02404
Date of first authorisation: 17 October 2014
Date of latest renewal: 22 March 2019
| Drug | Countries | |
|---|---|---|
| ATOZET | Austria, Australia, Germany, Ecuador, Spain, Hong Kong, Ireland, Israel, Japan, Malta, Mexico, Netherlands, Poland, Romania, Singapore |
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