Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 40 mg; ezetimibe, Quantity: 10 mg
Medis Pharma Pty Ltd
Tablet
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; iron oxide black; microcrystalline cellulose; iron oxide red; magnesium stearate; iron oxide yellow; ascorbic acid; propyl gallate; citric acid; butylated hydroxyanisole; hypromellose
Oral
5, 10, 30
(S4) Prescription Only Medicine
Adults (?18 years),Prevention of Cardiovascular Disease EZETIMIBE/SIMVASTATIN-ZP is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Clinical Trials).,Primary Hypercholesterolaemia EZETIMIBE/SIMVASTATIN-ZP is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: ? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH) EZETIMIBE/SIMVASTATIN-ZP is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). Children and Adolescents 10-17 years (pubertal status: boys Tanner Stage II and above and girls who are at least one year post- menarche),Heterozygous Familial Hypercholesterolaemia (HeFH) EZETIMIBE/SIMVASTATIN-ZP is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH) EZETIMIBE/SIMVASTATIN-ZP is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Visual Identification: Light tan, mottled, round about 10 mm, biconvex tablets. Marking 513 on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-11-06
Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets PRODUCT INFORMATION Medis Pharma Pty Ltd EZETIMIBE/SIMVASTATIN-ZP PI 0917 V5 Page 1 of 41 PRODUCT INFORMATION EZETIMIBE/SIMVASTATIN-ZP (ezetimibe and simvastatin) NAME OF THE MEDICINE _EZETIMIBE _ Chemical name: 1-(4-fluorophenyl)-3(_R_)-[3-(4-fluorophenyl)-3(_S_)- hydroxypropyl]-4(_S_)-(4-hydroxyphenyl)-2-azetidinone. Molecular formula: C 24 H 21 F 2 NO 3 Molecular weight: 409.4 CAS registry number: 163222-33-1 Its structural formula is: _SIMVASTATIN _ Chemical name: Simvastatin, an inactive lactone, is hydrolysed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is (1_S_,3_R_,7_S_,8_S_,8a_R_)-8-[2- [(2_R_,4_R_)-4-Hydroxy-6-oxotetrahydro-2_H_-pyran-2-yl]ethyl]-3-7-dimethyl- 1,2,3,7,8,8ahexahydronaphtalen-1-yl 2,2-dimethylbutonate. Molecular formula: C 25 H 38 O 5 Molecular weight: 418.57 CAS registry number: 79902-63-9 Structural formula: Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets PRODUCT INFORMATION Medis Pharma Pty Ltd EZETIMIBE/SIMVASTATIN-ZP PI 0917 V5 Page 2 of 41 DESCRIPTION Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Simvastatin is a white to off-white, non-hygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. EZETIMIBE/SIMVASTATIN-ZP (ezetimibe/simvastatin) is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol. EZETIMIBE/SIMVASTATIN-ZP is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/10), 20 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/20), 40 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/40), or 80 mg of simvastatin (EZETIMIBE/SIMVASTATIN-ZP 10/80). Each tablet contains the following inactive ingredien read_full_document