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.
Each film-coated tablet contains Pitavastatin Calcium INN equivalent to Pitavastatin 2 mg.
Pitavas is indicated 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 HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.
The dose is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. The starting and maintenance doses should be individualized according to patient characteristics, such as goal of therapy and response.
Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with Pitavastatin
Pitavastatin is generally well tolerated. The common side effects are headache, myalgia, asthenia, constipation, dizziness and abdominal pain. It may rarely cause rhabdomyolysis and hypersensitivity reaction.
Pitavastatin is metabolized primarily by glucuronidation and minimally by the cytochrome P450 system via CYP2C9 and CYP2C8, which may result in drug interactions with other medications metabolized via the same route.
Use in pregnancy: The safety and efficacy of Pitavastatin pregnancy have not been established.
Use in lactation: It is not known whether Pitavastatin is excreted in human milk
Use in children: Safety and effectiveness of Pitavastatin in pediatric patients have not been established.
Renal impairment: Patients with moderate renal impairment (glomerular filtration rate 30 to < 60 mL/min/1.73 m2) and end-stage renal disease receiving hemodialysis should receive a starting dose of Pitavastatin 1 mg once daily and a maximum dose of Pitavastatin 2 mg once daily.
Hepatic Impairment: Pitavastatin is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Use in elderly: No significant differences in efficacy or safety were observed between elderly patients and younger patients.
Pitavas-2 Tablet: Each box contains 30's tablets in blister pack.
FR
DE
