Atorvastatin calcium

Atorvastatin calcium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Atorvastatin calcium is a HMG-CoA reductase inhibitor that is FDA approved for the treatment of hyperlipidemia, prevention of cardiovascular disease. Common adverse reactions include diarrhea, arthralgia, myalgia, urinary tract infection, nasopharyngitis, pain in extremity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hyperlipidemia

• Dosing information

• Recommended starting dose: 10-20 mg PO qd
• Patients who require a large reduction in LDL-C (more than 45%): 40 mg PO qd
• Maximum dosage: 80 mg PO qd

• LIPITOR can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of LIPITOR should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of LIPITOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Homozygous Familial Hypercholesterolemia

• Dosing information

• 10-80 mg PO qd

• LIPITOR should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Concomitant Lipid-Lowering Therapy

• Dosing information

• LIPITOR may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions]], Skeletal Muscle (5.1), Drug Interactions (7)].

Dosage in Patients With Renal Impairment

• Dosing information

• Renal disease does not affect the plasma concentrations nor LDL-C reduction of LIPITOR; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle (5.1), Clinical Pharmacology, Pharmacokinetics (12.3)].

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Sandbox Atorvastatin in adult patients.

Non–Guideline-Supported Use

Antiviral drug adverse reaction, Antiretroviral

• Dosing information

• Monotherapy: 10 mg nightly for 24 weeks
• Combination Therapy: 10 mg/day with gemfibrozil 600 mg bid

Prophylaxis of Atrial fibrillation

• Dosing information

• 10-80 mg
• 20 mg
• 10 mg/day
• 80 mg

Prophylaxis of Cardiovascular event risk

• Dosing information

• 80 mg , ,
• 40 mg

Adjunct treatment of Diabetic Retinopathy

• Dosing information

• 10 mg

Dyslipidemia

• Dosing information

• 10 mg

Generalized atherosclerosis

• Dosing information

• 80 mg/day ,

Heart Failure

• Dosing information

• 80 mg

Peripheral vascular disease

• Dosing information

• 80 mg/day

Prophylaxis of Radiographic contrast agent nephropathy

• Dosing information

• 80 mg 12 hours before angiography followed by 40 mg approximately 2 hours prior to angiography. ，

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age)

• Dosing information

• Recommended dosage: 10 mg/day
• Maximum recommended dose: 20 mg/day

• Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology (12), and Indications and Usage (1.2)]. Adjustments should be made at intervals of 4 weeks or more.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Sandbox Atorvastatin in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Sandbox Atorvastatin in pediatric patients.

Contraindications

Active liver disease which may include unexplained persistent elevations in hepatic transaminase levels

Hypersensitivity to any component of this medication

Pregnancy

Women who are pregnant or may become pregnant. atorvastatin may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of atorvastatin use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, atorvastatin revealed no evidence of teratogenicity. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, atorvastatin should be discontinued immediately and the patient apprised of the potential hazard to the fetus.

Atherosclerosis is a chronic process and discontinuation of lipid lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia.

Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers.

Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.

If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus.

Nursing mothers

It is not known whether atorvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require atorvastatin treatment should not breastfeed their infants.

Warnings

There is limited information regarding Atorvastatin calcium Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Atorvastatin calcium Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Atorvastatin calcium Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Atorvastatin calcium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Atorvastatin calcium in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Atorvastatin calcium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Atorvastatin calcium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Atorvastatin calcium in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Atorvastatin calcium in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Atorvastatin calcium in geriatric settings.

Gender

There is no FDA guidance on the use of Atorvastatin calcium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Atorvastatin calcium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Atorvastatin calcium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Atorvastatin calcium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Atorvastatin calcium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Atorvastatin calcium in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Atorvastatin calcium Administration in the drug label.

Monitoring

There is limited information regarding Atorvastatin calcium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Atorvastatin calcium and IV administrations.

Overdosage

There is limited information regarding Atorvastatin calcium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Atorvastatin calcium Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Atorvastatin calcium Mechanism of Action in the drug label.

Structure

There is limited information regarding Atorvastatin calcium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Atorvastatin calcium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Atorvastatin calcium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Atorvastatin calcium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Atorvastatin calcium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Atorvastatin calcium How Supplied in the drug label.

Storage

There is limited information regarding Atorvastatin calcium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Atorvastatin calcium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Atorvastatin calcium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Atorvastatin calcium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Atorvastatin calcium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.