ATORVASTATIN CALCIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Composition:

ATORVASTATIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atorvastatin calcium tablets are indicated: Discontinue atorvastatin calcium tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformation

Product summary:

Atorvastatin Calcium Tablets, USP are available containing atorvastatin calcium, USP equivalent to 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin. The 10 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 10 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3950-77 bottles of 90 tablets NDC 0378-3950-05 bottles of 500 tablets The 20 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 20 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3951-77 bottles of 90 tablets NDC 0378-3951-05 bottles of 500 tablets The 40 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 40 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3952-77 bottles of 90 tablets NDC 0378-3952-05 bottles of 500 tablets The 80 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 80 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3953-77 bottles of 90 tablets NDC 0378-3953-05 bottles of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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 tablets are an HMG-CoA reductase inhibitor
(statin) indicated (1):
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg; 20 mg; 40 mg; 80 mg of atorvastatin (3).
CONTRAINDICATIONS
•
To reduce the risk of:
o
o
o
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:
o
o
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:
o
o
Primary dysbetaliproteinemia.
Hypertriglyceridemia.
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):
o
o
Reco