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• EZETIMIBE

It is an inhibitor of HMG-CoA reductase, a rate limiting enzyme in cholesterol synthesis. Inhibition of cholesterol synthesis in the liver leads to upregulation of LDL receptions and an increase in catabolism of LDL cholesterol. It decreases both normal and raised LDL-C, by increased catabolism and decreased production. It also decreases apoliprotein-B, VLDL-C plasma triglycerides and increases HDL-C.It is an inactive lactone, after ingestion it is hydrolyzed to active beta hydroxyl acid.

INDICATIONS: Hyperlipidaemias - Primary hypercholesterolemia (heterozygous familial and non familial), mixed dyslipidemia (II a and II B) in patients who have not responded adequately to diet and other appropriate measures; prevention of coronary events, need for revascularization of coronary atherosclerosis in patients with coronary heart diseases.

CONTRAINDICATIONS: Active liver diseases or increased serum transaminases, hypersensitivity to any component, renal impairment, pregnancy, lactation, children.

SAFETY PROFILE:

WARNINGS

Simvastatin therapy by temporally withheld or discounted in any patient with an acute serious condition suggestive of a myopathy or having risk factors predisposing to the development of renal failure e.g. acute infections, hypotension, major surgery, uraemia, severe metabolic, endocrine and electrolytes disorders and uncontrolled seizures.

ADVERSE EFFECTS: Constipation, flatulence, nausea, diarrhea, dyspepsia, abdominal pain, asthenia, headache, myalgia, arthralgia, eczema, pruritus, also alopecia, anaemia, dizziness, paresthesia, peripheral neuropathy, hepatitis, jaundice, pancreatitis, elevated serum transaminase, cataract, ophthalmoplegia and rarely rhabdomyolsis with acute renal failure.

DRUG INTERACTIONS: Increased incidence of rhabdomyolsis with immunosuppressants, itraconazole, ketoconazole, gemfibrozil, niacin, erythromycin, clarithromycin, verapamil. Slight increase in digoxin levels on concomitant therapy. It potentiates the effect of warfarin. Grapefruit juice increases plasma concentration of simvastatin. The HMG-CoA reductase inhibitor be given 2-4 hours after cholestyramine or colestipol.

DOSAGE: Primary hypercholesterolemia, heterozygous familial hypercholesterolemia, combined hyperlipidaemia: 10 mg daily at night, adjusted at interval of not less than 4 weeks; usual range 10-80 mg daily in 3 divided doses (with largest dose at night).

Coronary heart disease: initially 20 mg. once daily at night, adjusted at interval of not less than 4 weeks; max.80 mg. once daily.

NOTE: Max.10 m. daily with concomitant cyclosporine, fibrate or lipid - lowering dose of nicotinic acid.