Pitalip Adverse Reactions



Daewoong Pharmaceutical


Zuellig Pharma


Full Prescribing Info
Adverse Reactions
There are 22.2% of patients receiving pitavastatin reported adverse reactions in clinical controlled studies and their open-label extensions exhibited 3.9% of pitavastatin-treated patients were discontinued due to adverse reactions. Adverse reactions reported in this phase include arthralgia, headache, influenza, nasopharyngitis and allergy/hypersensitivity. Laboratory abnormalities are also informed, increase in serum CK, aminotransferase, alkaline phosphatase, bilirubin and glucose.
Postmarketing experience, 2% or more adverse reactions have been identified. Adverse reactions including 3.9% of back pain, 3.1% of myalgia, 3.6% constipation and 2.6% diarrhea observed during postapproval use of pitavastatin. Regardless of causality assessment, adverse reactions reported include the following: abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and non-fatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction and muscle spasms. The following is clinically significant adverse reactions.
Rhabdomyolysis (unknown incidence): The medical term for the breakdown of muscle fibers that results in the release of muscle fiber contents into the bloodstream. Signs and symptoms considered by pain, tenderness, weakness and swelling of muscles. Besides muscle pain, the other major symptom of rhabdomyolysis is dark, red, or cola colored urine due to myoglobinuria, and serum CK elevation may be observed. The serious complication of rhabdomyolysis, acute renal failure develops and may be associated with high morbidity and mortality, pitavastatin therapy should also be discontinued in any patient with these symptoms.
Myopathy (unknown incidence): The primary symptom is muscle weakness due to dysfunction of muscle fiber, may develop on occasion. Pitavastatin therapy should also be discontinued in any patient with extensive myalgia, muscle tenderness, cramps, stiffness, spasm or noticeable serum CK elevation.
Jaundice, Hepatic Dysfunction (unknown incidence): Persistent significant elevations in hepatic transaminases (AST and ALT) can occur. Check liver enzyme tests before initiating therapy and as routinely. Pitavastatin therapy should also be discontinued if clinically indicated and treat appropriately.
Platelet Count Decreased (unknown incidence): Low platelet levels may detected occasionally. Consequently, close monitoring blood tests are required. If any abnormality is identified, pitavastatin therapy should be discontinued and treat appropriately.
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