מדינה: פיליפינים
שפה: אנגלית
מקור: FDA (Food And Drug Administration)
Simvastatin
Getz Pharma (Phils.) Inc.
Simvastatin
20mg
Film-Coated Tablet
Alu/Alu Blister Pack x 10's (Box of 10's and 30's) and l's (Box of 1's) (Physician's sa, Alu/Alu Blister Pack x 10's (Box of 1
Getz Pharma (Private) Limited, Pakistan
2022-07-15
DESCRIPTION Simvastatin (Simvoget ® ) is a lipid-lowering agent that is derived synthetically from a fermentation product of _Aspergillus terreus._ Chemically simvastatin is butanoic acid, 2,2-dimethyl, 1,2,3,7,8, 8a-hexahydro-3, 7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H- pyran-2-yl) ethyl]-1-naphthalenyl ester,[1S-[1 α ,3 α ,7 β ,8 β (2S*,4S*), 8a β ]]. Its molecular formula is C 25 H 38 O 5 and structural formula is: FORMULATION Simvastatin (Simvoget ® ) is available for oral administration as: 1. Simvastatin (Simvoget ® ) Tablets 10mg Each film-coated tablet contains: Simvastatin USP… 10mg 2. Simvastatin (Simvoget ® ) Tablets 20mg Each film-coated tablet contains: Simvastatin USP…20mg 3. Simvastatin (Simvoget ® ) Tablets 40mg Each film-coated tablet contains: Simvastatin USP…40mg CLINICAL PHARMACOLOGY MECHANISM OF ACTION After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β -hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. PHARMACOKINETICS Simvastatin is absorbed from the gastrointestinal tract and is hydrolysed to its active β -hydroxyacid form. Other active metabolites have been detected and a number of inactive metabolites are also formed. Simvastatin undergoes extensive first pass metabolism in the liver, its primary site of action. Less than 5% of the oral dose has been reported to reach the circulation as active metabolites. Both simvastatin and its β -hydroxyacid metabolite are about 95% bound to plasma proteins. It is mainly excreted in the faeces via the bile as metabolites. About 10 to 15% is recovered in the urine, mainly in inactive forms. The half-life of active metabolite is 1.9 hours. THERAPEUTIC INDICATIONS _Reductions in Risk of CHD Mortality and Cardiovascular Events:_ In patients at high risk of coronary events because of existing c קרא את המסמך השלם