ATORVASTATIN CALCIUM tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Sun Pharmaceutical Industries Inc.

INN (Международно Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Композиция:

ATORVASTATIN 10 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Atorvastatin calcium tablets are indicated: Risk Summary Discontinue atorvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium 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 malformations. Published

Каталог на резюме:

Atorvastatin calcium tablets, USP 10 mg are white, elliptical, film-coated tablets, debossed with ‘RX 12 ’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 20 mg are white, elliptical, film-coated tablets, debossed with ‘RX 828 ’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 40 mg are white, elliptical, film-coated tablets, debossed with ‘RX 829 ’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 80 mg are white, elliptical, film-coated tablets, debossed with ‘RX 830 ’ on one side and plain on the other side. These are supplied as follows: Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Dispense in tight containers (USP).

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES INC.
REFERENCE LABEL SET ID: D385E07A-C16F-4AEF-8E55-AF95BD1C7526
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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
INDICATIONS AND USAGE
Atorvastatin calcium tablets are HMG-CoA reductase inhibitor (statin)
indicated (1): (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg; 20 mg; 40 mg; 80 mg of atorvastatin (3). (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
Contraindications, Pregnancy and Lactation (4) Removed 12/2022
Warnings and Precautions, CNS Toxicity (5.5) Removed 12/2022
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.
Take orally once daily with or without food (2.1).
Assess LDL-C when clinically appropriate, as ea