PRAVASTATIN SODIUM tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Rebel Distributors Corp

INN (Nama Internasional):

PRAVASTATIN SODIUM

Komposisi:

PRAVASTATIN SODIUM 40 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 is 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, Apo B, 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 tabl

Ringkasan produk:

Pravastatin sodium tablets are supplied as: 40 mg tablets: Green colored, rounded–rectangular shaped tablets having biconvex surface, with “G5” debossed on one surface and “40” debossed on the other surface. They are supplied in bottles of 30 (NDC 42254-131-30) and bottles of 90 (NDC 42254-131-90). Bottles contain a desiccant canister.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
REBEL DISTRIBUTORS CORP
----------
PRAVASTATIN SODIUM TABLETS
RX ONLY
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:
C
H
NaO MW 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 is available for oral administration as 10 mg, 20
mg, 40 mg, and 80 mg tablets.
Inactive ingredients include: colloidal silicon dioxide, crospovidone,
hydroxypropyl methylcellulose,
magnesium stearate, mannitol, meglumine, microcrystalline cellulose
and starch. The 10 mg, 20 mg and
80 mg tablets also contain D&C Yellow No 10 Aluminium Lake and the 40
mg tablet also contains D&C
Yellow No 10 Aluminium Lake and FD&C Blue No. 1-Aluminium 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 serie