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| __NOTOC__
| | #REDIRECT [[Pitavastatin#Warnings]] |
| {{Pitavastatin}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===Skeletal Muscle Effects===
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| Cases of [[myopathy]] and [[rhabdomyolysis]] with acute [[renal failure]] secondary to myoglobinuria have been reported with [[HMG-CoA]] reductase inhibitors, including LIVALO. These risks can occur at any dose level, but increase in a dose-dependent manner.
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| LIVALO 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]]. LIVALO 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[see Drug Interactions (7.6), Use in Specific Populations (8.5, 8.6) and Clinical Pharmacology (12.3)].
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| Cases of [[myopathy]], including [[rhabdomyolysis]], have been reported with [[HMG-CoA]] reductase inhibitors coadministered with [[colchicine]], and caution should be exercised when prescribing LIVALO with [[colchicine]] [see Drug Interactions (7.7)].
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| 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.
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| LIVALO therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or [[myopathy]] is diagnosed or suspected. LIVALO 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 disorder]]s, 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 LIVALO.
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| ===Liver Enzyme Abnormalities===
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| 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 LIVALO. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.
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| In placebo-controlled Phase 2 studies, ALT >3 times the upper limit of normal was not observed in the placebo, LIVALO 1 mg, or LIVALO 2 mg groups. One out of 202 patients (0.5%) administered LIVALO 4 mg had ALT >3 times the upper limit of normal.
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| It is recommended that liver enzyme tests be performed before the initiation of LIVALO and if signs or symptoms of liver injury occur.
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| 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 LIVALO, promptly interrupt therapy. If an alternate etiology is not found do not restart LIVALO.
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| As with other [[HMG-CoA]] reductase inhibitors, LIVALO 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 LIVALO [see Contraindications (4)].
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| ===Endocrine Function===
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| Increases in HbA1c and fasting serum glucose levels have been reported with [[HMG-CoA]] reductase inhibitors, including LIVALO.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2 | publisher = | date = | accessdate = 14 February 2014 }}</ref></div>
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| ==References==
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| {{Reflist|2}}
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| {{statins}}
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| [[Category:Statins]]
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| [[Category:Quinolines]]
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| [[Category:Diols]]
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| [[Category:Carboxylic acids]]
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| [[Category:Organofluorides]]
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| [[Category:Cyclopropanes]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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