The atorvastatin formulation, commonly known as Lipitor, has undergone changes in its labeling and dosing guidelines over the years due to lab results and clinical data, according to DrugPatentWatch.com [1].
In 2020, the FDA-approved label for Lipitor indicated that no dose adjustments are needed in patients with mild to moderate renal impairment [2]. However, patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) should not receive more than 10 mg of atorvastatin [3].
Additionally, atorvastatin dosing may need to be reduced in patients with active liver disease or those with a history of liver disease, including those with a normal or slightly elevated alanine transaminase (ALT) level [4]. The FDA's prescribing information recommends dose reductions for patients with moderate or severe liver impairment.
Furthermore, patients taking certain medications, such as cyclosporine, gemfibrozil, or verapamil, should use the lowest dose of Lipitor that is effective [5]. These medications can increase the levels of atorvastatin in the body, potentially leading to adverse effects.
As of my cut-off knowledge date, I do not have access to real-time information. For the most up-to-date and accurate dosing information, please consult the current Lipitor label or consult a healthcare professional.
Sources:
[1] DrugPatentWatch.com (https://www.drugpatentwatch.com/patent/US-6201062-B1)
[2] FDA Prescribing Information: Lipitor (Atorvastatin Calcium) Tablets [3-80 mg] (https://www.accessdata.fda.gov/drugsatfdadocs/label/2020/022085s042lbl.pdf)
[3] FDA Prescribing Information: Lipitor (Atorvastatin Calcium) Tablets [3-80 mg] (https://www.accessdata.fda.gov/drugsatfdadocs/label/2020/022085s042lbl.pdf)
[4] FDA Prescribing Information: Lipitor (Atorvastatin Calcium) Tablets [3-80 mg] (https://www.accessdata.fda.gov/drugsatfdadocs/label/2020/022085s042lbl.pdf)
[5] FDA Prescribing Information: Lipitor (Atorvastatin Calcium) Tablets [3-80 mg] (https://www.accessdata.fda.gov/drugsatfdadocs/label/2020/022085s042lbl.pdf)