Atorvastatin 10 mg Tablets — Generic For Lipitor — Novadoz

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

Recent Major Changes

Contraindications, Pregnancy and Lactation (4) Removed 12/2022

Warnings and Precautions, CNS Toxicity (5.5) Removed 12/2022

Indications And Usage

Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1):

To reduce the risk of:

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

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

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

As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:

Adults with primary hyperlipidemia.

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

As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.

As an adjunct to diet for the treatment of adults with:

Primary dysbetaliproteinemia.

Hypertriglyceridemia.

Dosage And Administration

Take orally once daily with or without food (2.1).

Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust dosage if necessary (2.1).

Adults (2.2):

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

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

Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily (2.3).

Pediatric Patients Aged 10 Years of Age and Older with HoFH: Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily (2.4).

See full prescribing information for atorvastatin calcium tablets dosage modifications due to drug interactions (2.5).

Dosage Forms And Strengths

Tablets: 10 mg; 20 mg; 40 mg; 80 mg of atorvastatin (3).

Contraindications

Acute liver failure or decompensated cirrhosis (4).

Hypersensitivity to atorvastatin or any excipient in atorvastatin calcium (4).

Warnings And Precautions

• , CNS Toxicity (5.5) Removed 12/2022 INDICATIONS AND USAGE Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1):
• To reduce the risk of:
• Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
• MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
• Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
• As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
• Adults with primary hyperlipidemia.
• Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).

• , CNS Toxicity (5.5) Removed 12/2022 INDICATIONS AND USAGE Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1):
• To reduce the risk of:
• Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
• MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
• Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
• As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
• Adults with primary hyperlipidemia.
• Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).

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).

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, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

See full prescribing information for details regarding concomitant use of atorvastatin calcium with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis (2.5, 7.1).

Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin calcium (7.2).

Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive (7.3).

Digoxin: May increase digoxin plasma levels; monitor patients appropriately (7.3).

Use In Specific Populations

Pregnancy: May cause fetal harm. (8.1).

Lactation: Breastfeeding not recommended during treatment with atorvastatin calcium (8.2).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2023