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ATORVASTATIN Calcium Tablets (GREENSTONE LLC)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

ATORVASTATIN Calcium Tablets (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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...

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2 DOSAGE AND ADMINISTRATION

2.1 Hyperlipidemia and Mixed Dyslipidemia

The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily....

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3 DOSAGE FORMS AND STRENGTHS

Atorvastatin calcium tablets are white elliptical, film-coated, and are available in four strengths (see

Table 1: Atorvastatin Calcium Tablet Strengths and...
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4 CONTRAINDICATIONS

  • Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels
  • Hypersensitivity to Any Component of This...
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5 WARNINGS AND PRECAUTIONS

5.1 Myopathy and Rhabdomyolysis

Atorvastatin calcium tablets may cause myopathy (...

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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Myopathy and Rhabdomyolysis [see

6.1 Clinical Trials Experience...

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7 DRUG INTERACTIONS

7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Tablets

Atorvastatin calcium is a...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Atorvastatin calcium...

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10 OVERDOSAGE

There is no specific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug...

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11 DESCRIPTION

Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/...

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14 CLINICAL STUDIES

14.1 Prevention of Cardiovascular Disease

In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of atorvastatin on fatal and non-...

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16 HOW SUPPLIED/STORAGE AND HANDLING

10 mg tablets (10 mg of atorvastatin): coded "PD 155" on one side and "10" on the other.

...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients taking atorvastatin calcium tablets should be advised that cholesterol is a chronic...

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PATIENT INFORMATION

Atorvastatin Calcium Tablets

Read the Patient Information that comes with atorvastatin calcium tablets before you start taking it and each time you get a refill. There may...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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