Source: FDA, National Drug Code (US) Revision Year: 2020
PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 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-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy), monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-.
Structural formula:
Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively 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 20 mg and 40 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone. The 20 mg tablets also contains 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).
| Dosage Forms and Strengths |
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PRAVACHOL Tablets are supplied as: 20 mg tablets: Yellow, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 20” engraved on the opposite side. 40 mg tablets: Green, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 40” engraved on the opposite side. |
| How Supplied |
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PRAVACHOL (pravastatin sodium) Tablets are supplied as: 20 mg tablets: Yellow, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 20” engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5178-05). Bottles contain a desiccant canister. 40 mg tablets: Green, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 40” engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5194-10). Bottles contain a desiccant canister. Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA |
| Drug | Countries | |
|---|---|---|
| PRAVACHOL | Australia, Turkey, United States |
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