দেশ: ইন্দোনেশিয়া
ভাষা: ইন্দোনেশীয়
সূত্র: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ATORVASTATIN CALCIUM TRIHYDRATE
PFIZER INDONESIA - Indonesia
ATORVASTATIN CALCIUM TRIHYDRATE
40 MG
TABLET SALUT SELAPUT
DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT (BULK)
PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany
2017-11-24
Generic Name: Atorvastatin Trade Name: Lipitor CDS Effective Date: December 15, 2020 Supersedes: January 24, 2020 Approved by BPOM: 2020-0064300 Page 1 of 22 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT GENERIC NAME: ATORVASTATIN TRADE NAME: LIPITOR CDS EFFECTIVE DATE: DECEMBER 15, 2020 SUPERSEDES: JANUARY 24, 2020 DESCRIPTION Atorvastatin tablets for oral administration contain 10 mg, 20 mg, 40 mg and 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate, Opadry White YS-1-7040, Antifoam AF Emulsion Medical. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Atorvastatin calcium is a synthetic lipid-lowering agent, which is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The empirical formula of atorvastatin calcium is (C 33 H 34 FN 2 O 5 ) 2 Ca • 3H 2 O and its molecular weight is 1209.42. Its structural formula is: Atorvastatin calcium is a white to off-white crystalline powder, practically insoluble in aqueous solutions of pH 4 and below. It is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile, slightly soluble in ethanol and freely soluble in methanol. DISETUJUI OLEH BPOM : 28/01/2022 ID REG : EREG10024112100282; EREG10024112100283; EREG10024112100284; EREG10024112100285; EREG10024112100286; EREG10024112100287; EREG10024112100288; EREG10024112100289. Generic Name: Atorvastatin Trade Name: Lipitor CDS Effective Date: December 15, 2020 Supersedes: January 24, 2020 Approved by BPOM: 2020-0064300 Page 2 of 22 MECHANISM OF ACTION - Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. In patients with homozygous and heterozygous familial hypercholes সম্পূর্ণ নথি পড়ুন