Precautions before taking Pitavastatin calcium

Pitavastatin calcium is a member of the medication class of statins, marketed in the United States under the trade name Pitavastatin calcium. Like other statins, it is an inhibitor of HMG-CoA reductase, the enzyme that catalyses the first step of cholesterol synthesis. It has been available in Japan since 2003, and is being marketed under licence in South Korea and in India. It is likely that pitavastatin will be approved for use in hypercholesterolaemia and for the prevention of cardiovascular disease outside South and Southeast Asia as well.In the US, it received FDA approval in 2009.

But, before using Pitavastatin calcium(CAS NO:147526-32-7), I have some warnings and precautions need to tell you!

1.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 calcium. These risks can occur at any dose level, but increase in a dose-dependent manner.

Pitavastatin calcium 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. It 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.

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 calcium therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Pitavastatin calcium 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. 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 this medicine.

2.Liver Enzyme Abnormalities

Increases in serum transaminases have been reported with HMG-CoA reductase inhibitors, including Pitavastatin calcium. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.

In placebo-controlled Phase 2 studies, ALT >3 times the upper limit of normal was not observed in the placebo, Pitavastatin calcium 1 mg, or Pitavastatin calcium 2 mg groups. One out of 202 patients (0.5%) administered Pitavastatin calcium 4 mg had ALT >3 times the upper limit of normal.

It is recommended that liver enzyme tests be performed before the initiation of Pitavastatin calcium 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 this medicine, promptly interrupt therapy. If an alternate etiology is not found do not restart this medicine.

As with other HMG-CoA reductase inhibitors, Pitavastatin calcium 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 calcium .

3.Endocrine Function

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Pitavastatin calcium.

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