降血脂 (statin) Primary hyperlipidemia or mixed dyslipidemia.
#仿單變更2021

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.

Bioavailability: 51%, plasma protein binding: 99%, primarily albumin and alpha 1-acid glycoprotein; the primary route of pitavastatin metabolism is glucuronidation via liver glucuronosyltransferases (UGT1A3 and UGT2B7); Elimination Half-life: 11-12 hrs.

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. 

X

Contraindication

Myalgia, back pain, diarrhea, constipation and pain in extremity.
Postmarketing: immune-mediated necrotizing myopathy (unexplained muscle weakness, CPK >10 times the ULN, anti-HMG-CoA reductase antibody positive, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing pitavastatin) <20210316>
Pediatric: headache, abdominal distress, myalgia <20210316>

Initial, 2 mg ORALLY daily; MAX 4 mg daily; dosage range 1 to 4 mg daily; assess lipid levels 4 weeks after dose initiation or titration; taken with or without food, at any time of day.

Children >8 years and Adolescents: Refer to adult dosing.
1. Renal impairment pediatric: There are no pediatric-specific recommendations (has not been established); based on experience in adult patients, dosage reductions should be considered.
2. Hepatic impairment pediatric: 1mg daily <20210316>

Dose adjustments according to GFR:
Moderate to severe renal impairment (GFR 15~59 mL/min/1.73 m²) as well as ESRD on H/D: Starting dose of 1 mg once daily and maximum dose of 2 mg once daily.  

Adult: Starting dose of 1 mg once daily and maximum dose of 2 mg once daily. <20210316>
Pediatric: 1mg daily <20210316>