Atorvastatin

Preview FDA label, Lepu Pharmaceutical Technology Co., Ltd., oral, effective 2025-10-29. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Renal Impairment Renal impairment is a risk factor for myopathy and rhabdomyolysis. Monitor all patients with renal impairment for development of myopathy. Renal impairment does not affect the plasma concentrations of atorvastatin calcium tablets, therefore there is no dosage adjustment in patients with renal impairment [see Warnings and Precautions and Clinical Pharmacology ].

Dosing in liver impairment

Hepatic Impairment In patients with chronic alcoholic liver disease, plasma concentrations of atorvastatin calcium tablets are markedly increased. Cmax and AUC are each 4-fold greater in patients with Childs-Pugh A disease. Cmax and AUC are approximately 16-fold and 11-fold increased, respectively, in patients with Childs-Pugh B disease.

Atorvastatin calcium tablets is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ].