Atorvastatin Calcium

ATORVASTATIN CALCIUM- atorvastatin calcium trihydrate tablet
RedPharm Drug, Inc.


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 administration
Initial U.S. Approval: 1996

INDICATIONS AND USAGE

Atorvastatin calcium tablet is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to:

Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors (1.1).
Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors (1.1).
Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD (1.1).
Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2).
Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).
Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.2).

Limitations of Use

Atorvastatin calcium tablets have not been studied in Fredrickson Types I and V dyslipidemias.

DOSAGE AND ADMINISTRATION

Dose range: 10 to 80 mg once daily (2.1).

Recommended start dose: 10 or 20 mg once daily (2.1).

Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily (2.1).

Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily (2.2).

DOSAGE FORMS AND STRENGTHS

10, 20 and 40 mg tablets (3).

CONTRAINDICATIONS

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4.1).

Women who are pregnant or may become pregnant (4.3).

Nursing mothers (4.4).

Hypersensitivity to any component of this medication (4.2).

WARNINGS AND PRECAUTIONS

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine, and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected (5.1, 8.5).

Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter (5.2).

A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the atorvastatin calcium 80 mg group vs. placebo (5.5).

ADVERSE REACTIONS

The most commonly reported adverse reactions (incidence ≥ 2%) in patients treated with atorvastatin calcium in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

DRUG INTERACTIONS

Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis (2.6, 5.1, 7, 12.3)

Interacting Agents Prescribing Recommendations
Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir) Avoid atorvastatin
HIV protease inhibitor (lopinavir plus ritonavir) Use with caution and lowest dose necessary
Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) Do not exceed 20 mg atorvastatin daily
HIV protease inhibitors (nelfinavir)
Hepatitis C protease inhibitor (boceprevir) Do not exceed 40 mg atorvastatin daily

Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with atorvastatin calcium (7).
Digoxin: Patients should be monitored appropriately (7.8).
Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased (7.9).
Rifampin should be simultaneously co-administered with atorvastatin calcium (7.7).

USE IN SPECIFIC POPULATIONS

Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease (12.3).

See 17 for PATIENT COUNSELING INFORMATION and PATIENT COUNSELING INFORMATION.

Revised: 9/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE
1.1 Prevention of Cardiovascular Disease
1.2 Hyperlipidemia
1.3 Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)
2.3 Homozygous Familial Hypercholesterolemia
2.4 Concomitant Lipid-Lowering Therapy
2.5 Dosage in Patients With Renal Impairment
2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.3 Pregnancy
4.4 Nursing mothers
5 WARNINGS AND PRECAUTIONS
5.1 Skeletal Muscle
5.2 Liver Dysfunction
5.3 Endocrine Function
5.4 CNS Toxicity
5.5 Use in Patients with Recent Stroke or TIA
6 ADVERSE REACTIONS
6.1 Clinical Trial Adverse Experiences
6.2 Postmarketing Experience
6.3 Pediatric Patients (ages 10 to 17 years)
7 DRUG INTERACTIONS
7.1 Strong Inhibitors of CYP 3A4
7.2 Grapefruit Juice
7.3 Cyclosporine
7.4 Gemfibrozil
7.5 Other Fibrates
7.6 Niacin
7.7 Rifampin or other Inducers of Cytochrome P450 3A4
7.8 Digoxin
7.9 Oral Contraceptives
7.10 Warfarin
7.11 Colchicine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Prevention of Cardiovascular Disease
14.2 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
14.3 Hypertriglyceridemia (Fredrickson Type IV)
14.4 Dysbetalipoproteinemia (Fredrickson Type III)
14.5 Homozygous Familial Hypercholesterolemia
14.6 Heterozygous Familial Hypercholesterolemia in Pediatric Patients
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Muscle Pain
17.2 Liver Enzymes
17.3 Pregnancy
17.4 Breastfeeding

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.

1.1 Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to:

Reduce the risk of myocardial infarction
Reduce the risk of stroke
Reduce the risk for revascularization procedures and angina

In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:

Reduce the risk of myocardial infarction
Reduce the risk of stroke

In patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:

Reduce the risk of non-fatal myocardial infarction
Reduce the risk of fatal and non-fatal stroke
Reduce the risk for revascularization procedures
Reduce the risk of hospitalization for CHF
Reduce the risk of angina

1.2 Hyperlipidemia

Atorvastatin calcium tablets are indicated:

As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:

a. LDL-C remains ≥ 190 mg/dL or

b. LDL-C remains ≥ 160 mg/dL and:

there is a positive family history of premature cardiovascular disease or
two or more other CVD risk factors are present in the pediatric patient

1.3 Limitations of Use

Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.