Pitavastatin Yarindo

Adjunct to diet for reduction of elevated total cholesterol (TC), LDL-C, Apo B, triglyceride, & to increase HDL-C in adults w/ primary hyperlipidemia or mixed dyslipidemia when response to diet & other non-pharmacological measures are inadequate. Reduction of elevated TC, LDL-C & Apo B in ped patient ≥8 yr w/ history of heterozygous familial hypercholesterolemia (HeFH).

1-4 mg once daily. Initial dose: 2 mg. Max daily dose: 4 mg. Patients w/ moderate & severe renal impairment (GFR 30-59 mL/min/1.73 m² & 15-29 mL/min/1.73 m²) w/o hemodialysis, ESRD on hemodialysis Initially 1 mg once daily. Max: 2 mg once daily. Patient taking erythromycin Max: 1 mg once daily, rifampicin Max: 2 mg once daily.

May be taken with or without food.

Hypersensitivity. Liver disease including unexplained persistent elevations of hepatic transaminases. Concomitant use w/ cyclosporine. Pregnancy & lactation.

Discontinue therapy if elevated creatine kinase levels occur or if myopathy is diagnosed or suspected; liver damage accompanied by clinical symptoms or hyperbilirubinemia or jaundice occurs. Temporarily discontinue in patients w/ serious acute myopathic conditions or predisposition to secondary renal failure caused by rhabdomyolysis (eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine & electrolyte disturbances, or uncontrolled seizures). Myopathy & rhabdomyolysis w/ acute kidney failure secondary to myoglobinuria. Patients w/ predisposing factors for myopathy including advanced age (>65 yr), renal impairment & poorly treated hypothyroidism. Patients who consume large amounts of alcohol. Monitor patients for immune-mediated necrotizing myopathy; at risk for hyperglycemia (fasting glucose 5.6-6.9 mmol/L, BMI 2.30 kg/mL, elevated triglycerides, HTN). Elevations in serum transaminases (AST or ALT); HbA1c & fasting glucose levels. Liver enzyme testing is recommended before therapy & if symptoms of liver damage develop. Increased risk of myopathy w/ concomitant administration of fibrates or lipids w/ niacin. Long-term use in ped patients. Ped patients <8 yr w/ HeFH or w/ other hyperlipidemias (other than HeFH).

Rhabdomyolysis w/ myoglobinuria, acute kidney failure, myopathy (including myositis). Liver enzyme abnormalities. Back pain, constipation, diarrhea, muscle pain & pain in the extremities. Arthralgia, headache, flu & nasopharyngitis. Increased creatinine phosphokinase, transaminase, alkaline phosphatase, bilirubin & glucose. Hypersensitivity reactions, including rash, pruritus & urticaria. Abdominal pain, indigestion, nausea, weakness, fatigue, malaise, hepatitis, jaundice, fatal & non-fatal liver failure, dizziness, hypoesthesia, insomnia, depression, ILD, erectile dysfunction & muscle spasms.

May increase conc w/ cyclosporine, erythromycin, rifampicin. Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil, other fibrates. May increase muscle pain w/ niacin.

Dyslipidaemic Agents

C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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