Patients with primary hyperlipidemia and mixed dyslipidemia, used as an adjunct to dietary control to help lower elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C).

Pitavastatin works by competitively inhibiting HMG-CoA reductase, a key enzyme responsible for cholesterol production in the liver. By blocking this enzyme, it reduces cholesterol synthesis. This leads to increased expression of LDL receptors, enhancing the uptake of LDL from the bloodstream into the liver, thereby lowering plasma total cholesterol. Additionally, prolonged inhibition of cholesterol synthesis reduces levels of very low-density lipoproteins (VLDL).

General Dosing Information: The dose range for pitavastatin 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 dose and maintenance doses of pitavastatin should be individualized according to patient characteristics, such as the goal of therapy and response. After initiation or upon titration of pitavastatin, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly. 

Dosage in Patients with Renal Impairment: Patients with moderate and severe renal impairment (glomerular filtration rate 30–59 mL/min/1.73 m2 and 15–29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as 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. 

Use with Erythromycin: In patients taking erythromycin, a dose of pitavastatin 1 mg once daily should not be exceeded. 

Use with Rifampin: In patients taking rifampin, a dose of pitavastatin 2 mg once daily should not be exceeded.

Cyclosporine: Co-administration of cyclosporine with Pitavastatin is contraindicated.
Erythromycin: Erythromycin significantly increases Pitavastatin exposure. In patients taking erythromycin, a dose of Pitavastatin 1 mg once daily should not be exceeded.

Rifampin: Rifampin significantly increases 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 Pitavastatin Calcium
• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Women who are pregnant or may become pregnant
• Co-administration with cyclosporine

The most commonly reported adverse effects include myalgia, back pain, diarrhoea, constipation, and pain in the extremities.

Pregnancy Category X. Pitavastatin is contraindicated in women who are pregnant or may become pregnant. It is not known whether pitavastatin is excreted in human milk; however, a small amount of similar drugs has been found in breast milk. Women requiring pitavastatin therapy should avoid breastfeeding or discontinue the drug.

Skeletal muscle effects (e.g. myopathy and rhabdomyolysis): Risks increase in a dose-dependent manner, especially in elderly patients (>65 years), those with renal impairment, untreated hypothyroidism, and when used with fibrates. Patients should report any unexplained muscle pain, tenderness, or weakness immediately, and discontinue the drug if symptoms occur.

Liver enzymes abnormalities and monitoring: Persistent elevations in hepatic transaminases may occur. Liver function should be checked before and during therapy.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Store in a cool and dry place, away from light and moisture. Keep out of reach of children.