Pitator Special Precautions



Orient Pharma




OEP Phils
Full Prescribing Info
Special Precautions
Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Pitavastatin. These risks can occur at any dose level, but increase in a dose-dependent manner.
Pitavastatin should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (≥65 years), renal impairment, and inadequately treated hypothyroidism. The risk of myopathy may also be increased with concurrent administration of fibrates or lipid-modifying doses of niacin. Pitavastatin should be administered with caution in patients with impaired renal function, in elderly patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin.
Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing Pitavastatin with colchicine.
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
Pitavastatin therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Pitavastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures). All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Pitavastatin.
Liver Enzyme Abnormalities: Increases in serum transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase, or alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase) have been reported with HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.
It is recommended that liver enzyme tests be performed before the initiation of Pitavastatin and if signs or symptoms of liver injury occur.
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pitavastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Pitavastatin, promptly interrupt therapy. If an alternate etiology is not found, do not restart Pitavastatin.
As with other HMG-CoA reductase inhibitors, Pitavastatin should be used with caution in patients who consume substantial quantities of alcohol. Active liver disease, which may include unexplained persistent transaminase elevations, is a contraindication to the use of Pitavastatin.
Endocrine Function: Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Pitavastatin.
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.
Hepatic Impairment: Pitavastatin is contraindicated in patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels.
Use in Children: Safety and effectiveness of Pitavastatin in pediatric patients have not been established.
Use in Elderly: No significant differences in efficacy or safety were observed between elderly patients and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
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