Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
pravastatin sodium (UNII: 3M8608UQ61) (pravastatin - UNII:KXO2KT9N0G)
Watson Laboratories, Inc.
PRAVASTATIN SODIUM
TABLET
10 mg
ORAL
PRESCRIPTION DRUG
Therapy with Pravastatin Sodium Tablets should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors. In hypercholesterolemic patients without clinically evident coronary heart disease, Pravastatin Sodium Tablets are indicated to: In patients with clinically evident coronary heart disease, Pravastatin Sodium Tablets are indicated to: Pravastatin Sodium Tablets are indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).8 Pravastatin Sodium Tablets are indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). Pravastatin Sodium Tablets are indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III)
Pravastatin Sodium Tablets are supplied as: 10 mg tablets: Pink to peach, rounded, rectangular-shaped, biconvex with a "10" embossed on one side and "0013" engraved on the opposite side. They are supplied in bottles of 90 (NDC 0591-0013-19). Bottles contain a desiccant canister. 20 mg tablets: Yellow, rounded, rectangular-shaped, biconvex with a "20" embossed on one side and "0014" engraved on the opposite side. They are supplied in bottles of 90 (NDC 0591-0014-19). Bottles contain a desiccant canister. 40 mg tablets: Green, rounded, rectangular-shaped, biconvex with a "40" embossed on one side and "0016" engraved on the opposite side. They are supplied in bottles of 90 (NDC 0591-0016-19). Bottles contain a desiccant canister. 80 mg tablets: Yellow, oval-shaped tablet with "80" on one side and "0019" on the other side. They are supplied in bottles of 90 (NDC 0591-0019-19) and bottles of 500 (NDC 0591-0019-05). Bottles contain a desiccant canister. Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET WATSON LABORATORIES, INC. ---------- PRAVASTATIN SODIUM TABLETS DESCRIPTION Pravastatin Sodium Tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive 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- 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. Pravastatin Sodium Tablets are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: croscarmellose sodium, lactose, magnesium oxide, magnesium 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). CLINICAL PHARMACOLOGY Cholesterol and triglycerides in the bloodstream circulate as part of lipoprotein complexes. These complexes can be separated by density ultracentrifugation into high (HDL), intermediate (IDL), low (LDL), and very low (VLDL) density lipoprotein fractions. Triglycerides (TG) and cholesterol synthesized in the liver are incorporated into very low density lipoproteins (VLDLs) and released into the plasma for delivery to peripheral tissues. In a se Citiți documentul complet