ATORVASTATIN CALCIUM tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NCS HealthCare of KY, LLC dba Vangard Labs

DCI (Dénomination commune internationale):

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

Composition:

ATORVASTATIN 10 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 adult patients with type 2 diabetes, and without clinically evident coronary heart disease

Descriptif du produit:

Atorvastatin calcium tablets, USP are supplied as white to off-white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin. 10 mg tablets Atorvastatin calcium tablets, USP 10 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side.  Blistercards of 30 (NDC 0615-8006-39) Blistercards of 15 (NDC 0615-8006-05) Blistercards of 7 (NDC 0615-8006-07) Unit Dose boxes of 30 (NDC 0615-8006-30) 20 mg tablets Atorvastatin calcium tablets, USP 20 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side.  40 mg tablets Atorvastatin calcium tablets, USP 40 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side.  80 mg tablets Atorvastatin calcium tablets, USP 80 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side.  Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight container [see USP].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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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
Dosage and Administration, Dosage in Patients Taking Cyclosporine,
Clarithromycin, Itraconazole,
Letermovir, or Certain Protease Inhibitors (2.6) 11/2019
Warnings and Precautions, Myopathy and Rhabdomyolysis (5.1) 11/2020
Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2)
9/2020
INDICATIONS AND USAGE
Atorvastatin calcium tablets are a HMG-CoA reductase inhibitor
indicated as an adjunct therapy to diet to:
Reduce the risk of MI, stroke, revascularization procedures, and
angina in adult patients without CHD,
but with multiple risk factors (1.1).
Reduce the risk of MI and stroke in adult 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 adult 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 adult 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 pediatric
patients, 10 years to 17 years of age, with
heterozygous familial hypercholesterolemia (HeFH) after failing an
adequate trial of diet therapy (1.2).
Limitations of Use:
Atorvastatin calcium has not been studied in _Fredrickson_ Types I and
V dyslipidemias (1.3).
DOSAGE AND ADMINISTRATION
Dose range: 10 to 80 m