PRAVASTATIN SODIUM tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)

Διαθέσιμο από:

Physicians Total Care, Inc.

INN (Διεθνής Όνομα):

PRAVASTATIN SODIUM

Σύνθεση:

PRAVASTATIN SODIUM 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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). Pravas

Περίληψη προϊόντος:

Pravastatin sodium tablets are supplied as: 10 mg tablets: Pink, unscored, round tablet, debossed “93” on one side and “771” on the other side in: bottles of 30   NDC 54868-5576-0 bottles of 90   NDC 54868-5576-1. 20 mg tablets: Light yellow, unscored, round tablet, debossed “93” on one side and “7201” on the other side in: bottles of 30   NDC 54868-5577-0 bottles of 90   NDC 54868-5577-1. 40 mg tablets: Light green, unscored, round tablet, debossed “93” on one side and “7202” on the other side in: bottles of 30   NDC 54868-5578-0 bottles of 60   NDC 54868-5578-2 bottles of 90   NDC 54868-5578-1. 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).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRAVASTATIN SODIUM - PRAVASTATIN SODIUM TABLET
PHYSICIANS TOTAL CARE, INC.
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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 (greater than 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 FD&C Blue No. 1.
Pravastatin sodium tablets USP are available for oral administration
as 80 mg tablets. Inactive
ingredients include: calcium phosphate dibasic, crospovidone, lactose,
magnesium stearate,
microcrystalline cellulose, and povidone.
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 lipopro