What is the FDA label for Lipitor (atorvastatin)?

FDA Label for Lipitor (Atorvastatin)

Lipitor (atorvastatin calcium) is FDA-approved for lipid management with specific dosing, contraindications, and safety considerations outlined in its official prescribing information. 1

Dosing Information

Adults

• Starting dose: 10 or 20 mg once daily 1
• Dosage range: 10 mg to 80 mg once daily 1
• For patients requiring LDL-C reduction >45%: May start at 40 mg once daily 1

Pediatric Patients (≥10 Years of Age)

Heterozygous Familial Hypercholesterolemia (HeFH):

• Starting dose: 10 mg once daily 1
• Dosage range: 10 to 20 mg once daily 1

Homozygous Familial Hypercholesterolemia (HoFH):

• Starting dose: 10 to 20 mg once daily 1
• Dosage range: 10 to 80 mg once daily 1

Available Strengths

• Tablets: 10 mg, 20 mg, 40 mg, and 80 mg 1

Contraindications

Absolute contraindications include:

• Acute liver failure or decompensated cirrhosis 1
• Hypersensitivity to atorvastatin or any excipient 1

Warnings and Precautions

Myopathy and Rhabdomyolysis

Risk factors include: age ≥65 years, uncontrolled hypothyroidism, renal impairment, concomitant use with certain drugs, and higher atorvastatin dosages 1

Management:

• Discontinue if markedly elevated CK levels occur or myopathy is diagnosed/suspected 1
• Temporarily discontinue in patients with acute conditions at high risk of renal failure secondary to rhabdomyolysis 1
• Instruct patients to report unexplained muscle pain, tenderness, or weakness, especially with malaise or fever 1

Immune-Mediated Necrotizing Myopathy (IMNM)

• Rare autoimmune myopathy reported with statin use 1
• Discontinue if IMNM is suspected 1

Hepatic Dysfunction

• Increases in serum transaminases have occurred, some persistent 1
• Rare reports of fatal and non-fatal hepatic failure 1
• Consider liver enzyme testing before initiating therapy and as clinically indicated 1
• Promptly discontinue if serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs 1

Common Adverse Reactions (≥5% Incidence)

• Nasopharyngitis 1
• Arthralgia 1
• Diarrhea 1
• Pain in extremity 1
• Urinary tract infection 1

Drug Interactions

Key interactions requiring dosage modifications or monitoring:

• Rifampin: May reduce atorvastatin plasma concentrations; administer simultaneously with atorvastatin 1
• Oral contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider when selecting contraceptive 1
• Digoxin: May increase digoxin plasma levels; monitor appropriately 1
• Grapefruit juice and other drugs: May increase risk of myopathy and rhabdomyolysis 1

Special Populations

Pregnancy:

• May cause fetal harm 1

Lactation:

• Breastfeeding not recommended during treatment 1