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:

State of Florida DOH Central Pharmacy

INN (International Name):

PRAVASTATIN SODIUM

Composition:

PRAVASTATIN SODIUM 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: - Reduce the risk of myocardial infarction - Reduce the risk of undergoing myocardial revascularization procedures - Reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes 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).6 Pravastatin sodium tablets are indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). Pravastatin sodi

Product summary:

Pravastatin sodium tablets are supplied as: 10 mg tablets: Pink, unscored, round tablet, debossed “93” on one side and “771” on the other side. 20 mg tablets: Light yellow, unscored, round tablet, debossed “93” on one side and “7201” on the other side. 40 mg tablets: Light green, unscored, round tablet, debossed “93” on one side and “7202” on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAVASTATIN SODIUM - PRAVASTATIN SODIUM TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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PRAVASTATIN SODIUM TABLETS
RX ONLY
DESCRIPTION
Pravastatin sodium is 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-naphthaleneheptanoic
acid, 1,2,6,7,8,8a-hexahydro-
β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium
salt, [1_S_-[1α
(β_S_*,δ_S_*),2α,6α,8β(_R_*),8aα]]-. It has the following
structural formula:
C
H
NaO M.W. 446.52
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, and 40 mg tablets.
Inactive ingredients include: calcium phosphate dibasic,
croscarmellose sodium, crospovidone, lactose,
microcrystalline cellulose, povidone, and sodium stearyl fumarate. The
10 mg tablet also contains ferric
oxide red, the 20 mg tablet also contains ferric oxide yellow, and the
40 mg tablet also contains Yellow
DC No. 10 and FDC Blue No. 1.
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 tiss