Atorvastatin warnings and precautions: Difference between revisions

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#REDIRECT [[Atorvastatin#Warnings]]
{{Atorvastatin}}
{{CMG}} ; {{AE}} , {{PB}}
 
==WARNINGS AND PRECAUTIONS==
 
===Skeletal Muscle===
 
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin and with other drugs in this class. A history of renal impairment may be a risk factor for the development of [[rhabdomyolysis]]. Such patients merit closer monitoring for skeletal muscle effects.
 
[[Atorvastatin]], like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., [[clarithromycin]], [[itraconazole]], and HIV protease inhibitors) increases the risk of [[myopathy]]/[[rhabdomyolysis]].
 
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.
 
[[Myopathy]] should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of [[CPK]]. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing atorvastatin. atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or [[myopathy]] is diagnosed or suspected.
 
The risk of [[myopathy]] during treatment with drugs in this class is increased with concurrent administration of [[cyclosporine]], fibric acid derivatives, [[erythromycin]], [[clarithromycin]], the [[hepatitis C]] protease inhibitor [[telaprevir]], combinations of HIV protease inhibitors, including [[saquinavir]] plus [[ritonavir]], [[lopinavir]] plus [[ritonavir]], [[tipranavir]] plus [[ritonavir]], [[darunavir]]plus [[ritonavir]], [[fosamprenavir]], and [[fosamprenavir]] plus [[ritonavir]], [[niacin]], or [[azole]] antifungals. Physicians considering combined therapy with atorvastatin and fibric acid derivatives, [[erythromycin]], [[clarithromycin]], a combination of [[saquinavir]] plus [[ritonavir]], [[lopinavir]] plus ritonavir, [[darunavir]] plus [[ritonavir]], [[fosamprenavir]], or [[fosamprenavir]] plus [[ritonavir]], azole antifungals, or lipid-modifying doses of [[niacin]]should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs (see Drug Interactions (7)). Periodic [[creatine phosphokinase]] (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = atorvastatin (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c6e131fe-e7df-4876-83f7-9156fc4e8228#nlm34089-3 | publisher =  | date =  | accessdate = }}</ref>
 
 
 
==References==
{{Reflist}}
 
{{FDA}}
 
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 14:43, 22 July 2014