ATORVASTATIN CALCIUM tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE (UNII: YRZ789OWMI) (ATORVASTATIN - UNII:A0JWA85V8F)

متاح من:

New Horizon Rx Group, LLC

INN (الاسم الدولي):

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

تركيب:

ATORVASTATIN 40 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - Reduce the risk of myocardial infarction - Reduce the risk of stroke - Reduce the risk for revascularization procedures and angina In patients with type 2 diabetes, and without clinically evident coronary heart disease, but

ملخص المنتج:

Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 40 mg atorvastatin. 40 mg tablets: Atorvastatin calcium tablets, 40 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side. Bottles of 30 (NDC 58517-001-30) Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM TABLET, FILM COATED
NEW HORIZON RX GROUP, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATORVASTATIN CALCIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATORVASTATIN
CALCIUM.
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED FOR
ORAL USE.
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Dosage and Administration (2.6) 10/2012
Warnings and Precautions (5.1) 10/ 2012
Drug Interactions (7) 02/2012
INDICATIONS AND USAGE
Atorvastatin calcium tablets are an inhibitor of HMG-CoA reductase
(statin) indicated as an adjunct therapy to diet to:
Reduce the risk of MI, stroke, revascularization procedures, and
angina in patients without CHD, but with multiple risk
factors (1.1).
Reduce the risk of MI and stroke in patients with type 2 diabetes
without CHD, but with multiple risk factors (1.1).
Reduce the risk of non-fatal MI, fatal and non-fatal stroke,
revascularization procedures, hospitalization for CHF, and
angina in patients with CHD (1.1).
Reduce elevated total-C, LDL-C, apo B, and TG levels and increase
HDL-C in adult patients with primary hyperlipidemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2).
Reduce elevated TG in patients with hypertriglyceridemia and primary
dysbetalipoproteinemia (1.2).
Reduce total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH) (1.2).
Reduce elevated total-C, LDL-C, and apo B levels in boys and
postmenarchal girls, 10 to 17 years of age, with
heterozygous familial hypercholesterolemia after failing an adequate
trial of diet therapy (1.2).
Limitations of Use
Atorvastatin calcium have not been studied in Fredrickson Types I and
V dyslipidemias.
DOSAGE AND ADMINISTRATION
Dose range: 10 to 80 mg once daily (2.1).
Recommended start dose: 10 or 20 mg once daily (2.1).
Patients requiring large LDL-C reduction (>45%) may start at 40 mg
once daily (2.1).
Pediatric starting dose: 10 mg once daily; maxim