It Is a HMG-CoA reductase InhIbItor IndIcated for: ? PatIents wIth prImary hyperlIpIdemIa or mIxed dyslIpIdemIa as an adjunctIve therapy to dIet to reduce elevated total cholesterol (TC), low-densIty lIpoproteIn cholesterol (LDL-C), apolIpoproteIn B (Apo B), trIglycerIdes (TG), and to Increase hIgh-densIty lIpoproteIn cholesterol (HDL-C)
Anti-anginal & Anti-ischaemic
Pitavastatin competitively inhibits HMG-CoA reductase, which is a rate-determining enzyme involved with biosynthesis of cholesterol, in a manner of competition with the substrate so that it inhibits cholesterol synthesis in the liver. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Further, the sustained inhibition of cholesterol synthesis in the liver decreases levels of very low density lipoproteins.
it can be taken with or without food, at any time of day Dose Range: 1 mg to 4 mg once daily ? Primary hyperlipidemia and mixed dyslipidemia: Starting dose 2 mg. When lowering of LDL-C is insufficient, the dosage may be increased to a maximum of 4 mg per day. ? Moderate and severe renal impairment (glomerular filtration rate 30 ? 59 and 15 - 29 mL/min/1.73 m2 , respectively) as well as endstage renal disease on hemodialysis: Starting dose of 1 mg once daily and maximum dose of 2 mg once daily
Cyclosporine: Co-administration of cyclosporine with Pitavastatin is contraindicated.
Erythromycin: Erythromycin significantly increased Pitavastatin exposure. In patients taking erythromycin, a dose of Pitavastatin 1 mg once daily should not be exceeded.
Rifampin: Rifampin significantly increased Pitavastatin exposure. In patients taking rifampin, a dose of Pitavastatin 2 mg once daily should not be exceeded.
Fibrates: Pitavastatin should be administered with caution when used concomitantly with gemfibrozil or other fibrates.
Warfarin: Pitavastatin had no significant pharmacokinetic interaction with warfarin.
Known hypersensitivity to product components ? Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ? Women who are pregnant or may become pregnant ? Nursing mothers ? Co-administration with cyclosporine ? Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase in a dose-dependent manner, with advanced age (>65), renal impairment, and inadequately treated hypothyroidism. Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, and discontinue it if signs or symptoms appear ? Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter
myalgia, back pain, diarrhea, constipation and pain in extremity.
Pregnancy Category X. Pitavastatin is contraindicated in women who are or may become pregnant. It is not known whether Pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk.
There is no known specific treatment in the event of overdose of pitavastatin. In the event of overdose, the patient should be treated
symptomatically and supportive measures instituted as required. Hemodialysis is unlikely to be of benefit due to high protein binding
ratio of pitavastatin.
Store in a cool and dry place, protect from light & moisture. Keep out of the reach of children.
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