PRAVASTATIN SODIUM tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Lake Erie Medical DBA Quality Care Products LLC

INN (الاسم الدولي):

pravastatin sodium

تركيب:

pravastatin sodium 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Therapy with Pravastatin Sodium Tablets, USP 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, USP 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, USP 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, USP are indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type

ملخص المنتج:

Pravastatin Sodium Tablets, USP 10 mg are available for oral administration as light pink, round, unscored tablets, imprinted “APO” on one side and “PRA” over “10” on the other side. They are supplied as follows: NDC: 35356-921-30  Bottles of 30 NDC: 35356-921-60  Bottles of 60 NDC: 35356-921-90  Bottles of 90 Pravastatin Sodium Tablets, USP 20 mg are available for oral administration as off-white to light yellow, round, unscored tablets, imprinted “APO” on one side and “PRA” over “20” on the other side. They are supplied as follows: NDC: 35356-919-30  Bottles of 30 NDC: 35356-919-60  Bottles of 60 NDC: 35356-919-90  Bottles of 90 Pravastatin Sodium Tablets, USP 40 mg are available for oral administration as light green, round, unscored tablets, imprinted “APO” on one side and “PRA” over “40” on the other side. They are supplied as follows: NDC: 35356-125-30  Bottles of 30 NDC: 35356-125-60  Bottles of 60 NDC: 35356-125-90  Bottles of 90 Pravastatin Sodium Tablets, USP 80 mg are available for oral administration as off-white to light yellow, round, unscored tablets, imprinted "APO" on one side and "PRA" over "80" on the other side. They are supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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PRAVASTATIN SODIUM TABLETS, USP
10 MG, 20 MG, 40 MG AND 80 MG
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 Sodium
(3R,5R)-3,5-dihydroxy-7-
[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-
hexahydronaphthalen-1-yl]heptanoate.
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.
Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or
80 mg of
pravastatin sodium. In addition, each tablet contains the following
inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate and
microcrystalline
cellulose. The 10 mg tablet also contains red ferric oxide, the 20 mg
tablet also contains
yellow ferric oxide, and the 40 mg tablet also contains a blend of
yellow ferric oxide and
FD&C blue #1, and the 80 mg tablet also contains yellow ferric oxide.
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 del