Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PITAVASTATIN CALCIUM
TANABE INDONESIA - Indonesia
PITAVASTATIN CALCIUM
2 MG
TABLET SALUT SELAPUT
DRUM @ 150.000 - 250.000 TABLET SALUT SELAPUT
TANABE INDONESIA - Indonesia
2019-02-28
1 HMG-CoA Reductase Inhibitor LIVALO (Pitavastatin Calcium 2mg & Pitavastatin Calcium 4mg) LIVALO 2: REG. NO. DKL1925202817A1 LIVALO 4: REG. NO. DKL1925202817B1 (COMPOSITION AND DESCRIPTION) PHYSICOCHEMISTRY NONPROPRIETARY NAME: Pitavastatin calcium CHEMICAL NAME: (+)-Monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl- 4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6- heptenoate} CHEMICAL STRUCTURE: MOLECULAR FORMULA: C 50 H 46 CaF 2 N 2 O 8 MOLECULAR WEIGHT: 880.98 DESCRIPTION: A white to pale yellowish odorless powder. It is freely soluble in pyridine or in tetrahydrofuran, soluble in ethylene glycol, slightly soluble in methanol, very slightly soluble in ethanol (99.5) or in water, practically insoluble in acetonitrile or in diethyl ether. It dissolves in dilute hydrochloric acid. Brand Name LIVALO 2 LIVALO 4 Active Ingredient Each tablet contains 2 mg of pitavastatin calcium Each tablet contains 4 mg of pitavastatin calcium Inactive Ingredients Lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium aluminometasilicate, magnesium stearate, triethyl citrate, hydrated silicon dioxide, titanium oxide, carnauba wax, food yellow No. 5 (sunset yellow FCF) Color / Dosage Form Slightly light-colored yellow-red round scored film-coated tablet with a secant line. Light yellow, round scored film- coated tablet with a secant line. Appearance Diameter: 7.1 ㎜ Thickness: 2.9 ㎜ Weight:125 mg Diameter: 8.6 ㎜ Thickness: 3.9 ㎜ Weight:249 mg ID Code 202 203 (ACTIONS) CLINICAL PHARMACOLOGY 1. MECHANISM OF ACTION Pitavastatin competitively inhibits HMG-CoA reductase, which is a rate-determining enzyme involved with biosynthesis of cholesterol, in a manner of competition with the substrate so that it inhibits cholesterol synthesis in the liver. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Further, the sustained inhibition of cholesterol synthesis in the liver decreases levels of very low density lipoproteins. 2. PHAR Baca dokumen lengkapnya