Atorvastatin 80 mg Tablets — Generic For Lipitor — Camber

These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS.

ATORVASTATIN CALCIUM tablets, for oral use

Initial U.S. Approval: 1996

Indications And Usage

Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated

(1):

o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.

o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.

o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.

o Adults with primary hyperlipidemia.

o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).

o Primary dysbetalipoproteinemia.

o Hypertriglyceridemia.

Dosage And Administration

2.1).

2.1).

2.2):

o Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily.

o Patients requiring LDL-C reduction >45% may start at 40 mg once daily.

2.3).

2.4).

2.5).

Dosage Forms And Strengths

Tablets: 10 mg; 20 mg; 40 mg; 80 mg of atorvastatin (

3).

Contraindications

4).

4).

Warnings And Precautions

• Myopathy and Rhabdomyolysis:Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin calcium dosage. Discontinue atorvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing atorvastatin calcium dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever ( 2.5, 5.1, 7.1, 8.5, 8.6) .
• Immune-Mediated Necrotizing Myopathy (IMNM):Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue atorvastatin calcium if IMNM is suspected ( 5.2).
• Hepatic Dysfunction:Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium ( 5.3).

• Myopathy and Rhabdomyolysis:Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin calcium dosage. Discontinue atorvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing atorvastatin calcium dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever ( 2.5, 5.1, 7.1, 8.5, 8.6) .
• Immune-Mediated Necrotizing Myopathy (IMNM):Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue atorvastatin calcium if IMNM is suspected ( 5.2).
• Hepatic Dysfunction:Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium ( 5.3).

2.5,

5.1,

7.1,

8.5,

8.6)

5.2).

5.3).

Adverse Reactions

Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (

6.1).

To report SUSPECTED ADVERSE REACTIONS, Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

2.5,

7.1).

7.2).

7.3).

7.3).

Use In Specific Populations

8.1).

8.2).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2025