PRAVASTATIN SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pravastatin sodium (UNII: 3M8608UQ61) (pravastatin - UNII:KXO2KT9N0G)

Available from:

Watson Laboratories, Inc.

INN (International Name):

PRAVASTATIN SODIUM

Pharmaceutical form:

TABLET

Composition:

10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)

Product summary:

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.

Summary of Product characteristics

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