2. DRUG PROFILE
2.1 Description of Pitavastatin:
Pitavastatin is a inhibitor of HMG-CoA enzyme reductase. It is aoral synthetic lipid-lowering agent. The chemical name for Pitavastatin is (+) mono calciumbis {(3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyI]-3,5dihydroxy-6-heptenoate}
The structural formula is:
Figure 05: Pitavastatin Chemical structure
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Pitavastatin is slightly unstable in light and hygroscopic. Each film-coated Pitavastatin tablet contains 1.045 mg or 2.09 mg, or 4.18 mg of pitavastatin calcium, which is equivalent to 1 mg or2 mg or 4 mg, respectively of free base and the following inactive ingredients: lactose monohydrate, hypromellose, magnesium stearate,magnesium alumina meta silicate, low substituted hydroxylpropyl cellulose and film coating containing the following inactive ingredients: titanium dioxide, hypromellose, colloidal anhydrous silica and triethyl citrate.
2.2 Mechanism of Action and Pharmacology:
Pitavastatin drug competitively inhibits HMG-CoA reductase enzyme, which is a rate-determining enzymeinvolved in the biosynthesis of cholesterol, in the manner of competition with a substrate sothat it inhibits cholesterol synthesis process in liver. As a result of it, the expression of LDL-receptorsand followed by the uptake of the LDL from blood to liver is accelerated,and then the plasma TCdecreases. Further, the sustained inhibition of the cholesterol synthesis in liver decreaseslevels of VLDL(very low density lipoproteins).
2.3 Indications and usage:
2.3.1 Primary Hyperlipidemia and Mixed Dyslipidemia:
Pitavastatin is indicated to reduce elevated total cholesterol(TC), triglycerides (TG),Apo lipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), and to increase HDL-C in adult patients with mixed dyslipidemia or primary