Lipitor 20 mg/1

atorvastatin calcium · TABLET, FILM COATED · Viatris Specialty LLC

1 Recall on Record

Plain English

Lipitor is a tablet, film coated containing atorvastatin calcium at 20 mg/1, taken oral. Manufactured by Viatris Specialty LLC.

Key Facts

Brand Name: Lipitor
Generic Name: atorvastatin calcium
NDC Code (Product): 58151-156
Manufacturer: Viatris Specialty LLC
Strength: 20 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020702
Marketing Start: 02/20/2024

Recall History

1 Recall on Record

Class II02/08/2012

Physicians Total Care, Inc.

Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue14,031 reports

drug ineffective13,003 reports

nausea12,596 reports

type 2 diabetes mellitus11,250 reports

diarrhoea11,236 reports

dyspnoea11,231 reports

pain10,155 reports

myalgia9,888 reports

dizziness9,854 reports

headache9,836 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE LIPITOR is indicated: • To reduce the risk of: 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 • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia LIPITOR is an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): • To reduce t…

Dosage & Administration

2 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 LIPITOR, and adjust dosage if necessary ( 2.1 ). • Adults ( 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. • 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 LIPITOR dosage modifications due to drug interactions ( 2.5 ). 2.1 Important Dosage Information • Take Lipitor orally once daily at any time of the day, with or without food. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating LIPITOR, and adjust the dosage if necessary. • If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose. 2.2 Recommended Dosage…

Contraindications

4 CONTRAINDICATIONS • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] • Hypersensitivity to atorvastatin or any excipients in LIPITOR. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions (6.2) ] . • Acute liver failure or decompensated cirrhosis ( 4 ). • Hypersensitivity to atorvastatin or any excipient in LIPITOR ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS • See full prescribing information for details regarding concomitant use of LIPITOR 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 LIPITOR ( 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 ). 7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with LIPITOR LIPITOR is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). LIPITOR plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 includes a list of drugs that may increase exposure to LIPITOR and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Table 2: Drug Interactions that may Increase the Risk of My…

Adverse Reactions

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] 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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the LIPITOR placebo-controlled clinical trial database of 16,066 patients (8755 LIPITOR vs. 7,311 placebo; age range 10-93 years, 39% female, 91% White, 3% Black or African American, 2% Asian, 4% other)…

Frequently Asked Questions

What is Lipitor used for?

Lipitor contains atorvastatin calcium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Lipitor a controlled substance?

Lipitor is not classified as a controlled substance by the DEA.

What is the generic name for Lipitor?

The generic name for Lipitor is atorvastatin calcium. There are 12 other brand versions of atorvastatin calcium.

What is the NDC code for Lipitor 20 mg/1?

The NDC (National Drug Code) for Lipitor 20 mg/1 is 58151-156, listed by Viatris Specialty LLC.

Product NDC

58151-156

Package NDC

58151-156-77

Other Atorvastatin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)