Pravachol

[Pravastatin]

Drug Description
DESCRIPTION

PRAVACHOL ® (pravastatin sodium) is one of a new class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are com-petitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.

Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro- , ,6-trihydroxy-2-methyl-8-( 2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[ 1 ( S*, S*), 2 ,6 ,8 (R*), 8a ]]-. C 23 H 35 NaO 7 MW 446.52

Text Continues Below

---

Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a rel-atively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7.0. It is soluble in methanol and water ( 300 mg/ mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether.

PRAVACHOL is available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose, magnesium oxide, mag-nesium stearate, microcrystalline cellulose, and povidone. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg and 80 mg tablets also contain Yellow Ferric Oxide, and the 40 mg tablet also contains Green Lake Blend (mixture of D& C Yellow No. 10-Aluminum Lake and FD& C Blue No. 1-Aluminum Lake).