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Covastin

COVASTIN

Simvastatin

 

COMPOSITION

Covastin Film-Coated Tablets 10mg:

Each tablet contains Simvastatin U.S.P. 10 mg

Covastin Film-Coated Tablets 20mg:

Each tablet contains Simvastatin U.S.P. 20 mg

Covastin Film-Coated Tablets 40mg:

Each tablet contains Simvastatin U.S.P. 40 mg

 

MODE OF ACTION

Simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form after oral ingestion. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.

 

PHARMACOLOGY

Covastin reduces both normal and elevated low-density lipoprotein cholesterol (LDL-C) concentrations in plasma. LDL is formed from very-low-density lipoprotein (VLDL) and is catabolized predominantly by the high-affinity LDL receptor on hepatocyte membranes. The mechanism of the LDL-lowering effect of simvastatin may involve both reduction of VLDL cholesterol (VLDL-C) concentration, and induction of the LDL receptor, leading to reduced production and/or increased catabolism of LDL-C. In addition, Covastin also reduces VLDL-C and triglycerides (TG) and increases high-density lipoprotein cholesterol (HDL-C) concentrations.

 

Pharmacokinetics:

Simvastatin is absorbed from the gastrointestinal tract and is hydrolysed to its active β-hydroxyacid form. Other active metabolites have been detected and a number of inactive metabolites are also formed.

 

Simvastatin undergoes extensive first-pass metabolism in the liver, its primary site of action, with subsequent excretion of drug equivalents in the bile. As a consequence of extensive hepatic extraction of simvastatin, the availability of active metabolites of an oral dose to the general circulation is low, reported to be less than 5%.

 

Both simvastatin and its β-hydroxyacid metabolite are highly bound (approximately 95%) to human plasma proteins. Peak plasma concentration of β-hydroxyacid metabolites was attained within 1.3 to 2.4 hours postdose.

 

Simvastatin is mainly excreted in the feces via the bile as metabolites. About 10 to 15% is recovered in the urine, mainly in inactive forms.

 

INDICATION

Therapy with lipid-altering agents should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence of congestive heart failure, or other risk factors. Covastin is used when the response to a saturated fat and cholesterol- restricted diet and other non-pharmacological measures alone has been inadequate.

 

Coronary Heart Disease

In patients with coronary heart disease and hypercholesterolemia, Covastin is indicated to:

Reduce the risk of total mortality by reducing coronary death.

Reduce the risk of non-fatal myocardial infarction.

Reduce the risk for undergoing myocardial revascularization procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty).

Slow the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

 

Hyperlipidemia

Covastin is indicated as an adjunct to diet for reduction of elevated total-cholesterol, LDL-C, apolipoprotein B (Apo B), and TG in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia when response to diet and other nonpharmacological measures is inadequate. Covastin also raises HDL-C and therefore lowers the LDL/HDL and total cholesterol/HDL ratios.

 

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