ATORVASTATIN CALCIUM 80 mg/1
ATORVASTATIN CALCIUM · TABLET, FILM COATED · ScieGen Pharmaceuticals, Inc.
Atorvastatin Calcium is a prescription tablet taken by mouth that belongs to a class of drugs called statins, which work to lower cholesterol and reduce the risk of heart disease. It is commonly prescribed to help manage high cholesterol levels in patients.
Key Facts
- Brand Name
- ATORVASTATIN CALCIUM
- Generic Name
- ATORVASTATIN CALCIUM
- NDC Code (Product)
50228-454- Manufacturer
- ScieGen Pharmaceuticals, Inc.
- Strength
- 80 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA205519
- Drug Class
- HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- Marketing Start
- 05/19/2016
Recall History
Ranbaxy Inc.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Ascend Laboratories, LLC
Failed Dissolution Specifications
Dr. Reddy's Laboratories, Inc.
Subpotent drug
Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Mylan Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Atorvastatin calcium tablets are indicated: 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 cholesterol (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, 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: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicate…
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 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 ). 2.1 Important Dosage Information Take atorvastatin calcium tablets 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 atorvastatin calcium tablets, and adjust the dosage if necessary. 2.2 Recommended Dosage in Adult Patients The recommended starting …
Contraindications
4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium. 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 atorvastatin calcium ( 4 ).
Drug Interactions
7 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 ). 7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin 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 atorvastatin 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 I…
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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 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 atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin calcium vs. 7311 placebo; age range 10 to 93 years, 39% women, 91% White, 3% Black, 2% Asian, 4% other…
Frequently Asked Questions
What is ATORVASTATIN CALCIUM used for?
Atorvastatin Calcium is a prescription tablet taken by mouth that belongs to a class of drugs called statins, which work to lower cholesterol and reduce the risk of heart disease. It is commonly prescribed to help manage high cholesterol levels in patients.
Is ATORVASTATIN CALCIUM a controlled substance?
ATORVASTATIN CALCIUM is not classified as a controlled substance by the DEA.
What is the generic name for ATORVASTATIN CALCIUM?
The generic name for ATORVASTATIN CALCIUM is ATORVASTATIN CALCIUM. There are 5 other brand versions of ATORVASTATIN CALCIUM.
What is the NDC code for ATORVASTATIN CALCIUM 80 mg/1?
The NDC (National Drug Code) for ATORVASTATIN CALCIUM 80 mg/1 is 50228-454, listed by ScieGen Pharmaceuticals, Inc..