PRAVASTATIN SODIUM tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
10-11-2010

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Rebel Distributors Corp

INN (Jina la Kimataifa):

pravastatin sodium

Tungo:

pravastatin 10 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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).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 sodi

Bidhaa muhtasari:

Pravastatin Sodium Tablets are supplied as: 10 mg tablets : White to off-white, capsule shaped tablet with "PV 10" on one side and “»” on the other side. They are supplies as follow: NDC 21695-178-30-Bottles of 30 20 mg tablets : White to off-white, capsule shaped tablet with "PV 20" on one side and “»” on the other side. They are supplies as follow: NDC 21695-179-30-Bottles of 30 NDC 21695-179-90-Bottles of 90 40 mg tablets : White to off-white, capsule shaped tablet with “»” on one side and “PV 40” on the other side. They are supplies as follow: NDC 21695-180-30-Bottles of 30 NDC 21695-180-90-Bottles of 90 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
REBEL DISTRIBUTORS CORP
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PRAVASTATIN SODIUM TABLETS USP
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-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]]-.
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, 40 mg and 80 mg
tablets. Inactive ingredients include: croscarmellose sodium, lactose
monohydrate (spray dried),
magnesium stearate, microcrystalline cellulose, povidone, magnesium
aluminum silicate, talc.
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 series of
subsequent steps, VLDLs are transformed
into intermediate density lipoproteins (IDLs), and cholesterol-rich
low density lipoproteins (LDLs).
High density lipoproteins
                                
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