ATORVASTATIN CALCIUM tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)

Tilgjengelig fra:

Accord Healthcare Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Atorvastatin calcium tablets is 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 - 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 cli

Produkt oppsummering:

Atorvastatin calcium tablets USP 10 mg (10 mg of atorvastatin) : White to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF1” on one side and plain on other side. NDC 16729-044-10 bottles of 30’s count with child-resistant closure NDC 16729-044-15 bottles of 90’s count with child-resistant closure NDC 16729-044-01 bottles of 100’s count with child-resistant closure NDC 16729-044-16 bottles of 500’s count NDC 16729-044-17 bottles of 1000’s count Atorvastatin calcium tablets USP 20 mg (20 mg of atorvastatin) : White to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF2” on one side and plain on other side. NDC 16729-045-10 bottles of 30’s count with child-resistant closure NDC 16729-045-15 bottles of 90’s count with child-resistant closure NDC 16729-045-01 bottles of 100’s count with child-resistant closure NDC 16729-045-16 bottles of 500’s count NDC 16729-045-17 bottles of 1000’s count Atorvastatin calcium tablets USP 40 mg (40 mg of atorvastatin) : White to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF3” on one side and plain on other side. NDC 16729-046-10 bottles of 30’s count with child-resistant closure NDC 16729-046-15 bottles of 90’s count with child-resistant closure NDC 16729-046-01 bottles of 100’s count with child-resistant closure NDC 16729-046-16 bottles of 500’s count NDC 16729-046-17 bottles of 1000’s count Atorvastatin calcium tablets USP 80 mg (80 mg of atorvastatin) : White to off-white, oval shaped, biconvex, film coated tablets, debossed with “FF4” on one side and plain on other side. NDC 16729-047-10 bottles of 30’s count with child-resistant closure NDC 16729-047-15 bottles of 90’s count with child-resistant closure NDC 16729-047-01 bottles of 100’s count with child-resistant closure NDC 16729-047-16 bottles of 500’s count NDC 16729-047-17 bottles of 1000’s count Storage Store at controlled room temperature 20 o C to 25 o C (68 o F to 77 o F).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
ACCORD HEALTHCARE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Contraindications, Pregnancy and Lactation ( 4)
Removed 12/2022
Warnings and Precautions, CNS Toxicity ( 5.5)
Removed 12/2022
INDICATIONS AND USAGE
Atorvastatin calcium is an HMG-CoA reductase inhibitor (statin)
indicated ( 1):
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 (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 to reduce LDL-C in
adults and pediatric patients aged
10 years and older with homozygous familial hypercholesterolemia.
As an adjunct to diet for the treatment of adults with:
Primary dysbetaliproteinemia.
Hypertriglyceridemia.
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, 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 Pat