ATORVASTATIN CALCIUM- atorvastatin calcium tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Algemene Internationale Benaming):

ATORVASTATIN CALCIUM TRIHYDRATE

Samenstelling:

ATORVASTATIN 10 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 dise

Product samenvatting:

Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets  debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in blistercards of 30’s and 15's. Blistercards of 30                                                               NDC 0615-7769-39 Blistercards of 15                                                               NDC 0615-7769-05 Unit-Dose Boxes of 30                                                       NDC 0615-7769-30 Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets  debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in blistercards of 30’s and 15’s. Blistercards of 30                                                               NDC 0615-7770-39 Blistercards of 15                                                               NDC 0615-7770-05 Unit-Dose Boxes of 30                                                       NDC 0615-7770-30 Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets  debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in blistercard of 30’s and 15’s. Blistercards of 30                                                               NDC 0615-7771-39 Blistercards of 15                                                               NDC 0615-7771-05 Unit-Dose Boxes of 30                                                       NDC 0615-7771-30 Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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 TABLETS FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration (2.6) 10/2012
Warnings and Precautions (5.1) 10/2012
INDICATIONS AND USAGE
Atorvastatin calcium tablet is 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 tablets 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; maximum recommended dose:
20 mg once daily (2.2).