ATORVASTATIN CALCIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DirectRx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels Hypersensitivity to Any Component of This Medication Pregnancy [see Use in Specific Population s(8.1, 8.3)]. Lactation [see Use in Specific Population s(8.2)]. 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. 1.1 Prevention of Cardiovascular Disease in Adults In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, l

Product summary:

10 mg tablets (10 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A16" on the other side. 20 mg tablets (20 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A17" on the other side. 40 mg tablets (40 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A18" on the other side. 80 mg tablets (80 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A19" on the other side. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET
DIRECTRX
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ATORVASTATIN CALCIUM
2.1 Hyperlipidemia and Mixed Dyslipidemia
The recommended starting dose of atorvastatin calcium is 10 or 20 mg
once daily.
Patients who require a large reduction in LDL-C (more than 45%) may be
started at 40
mg once daily. The dosage range of atorvastatin calcium is 10 to 80 mg
once daily.
Atorvastatin calcium can be administered as a single dose at anytime
of the day, with or
without food. The starting dose and maintenance doses of atorvastatin
calcium should
be individualized according to patient characteristics such as goal of
therapy and
response. After initiation and/or upon titration of atorvastatin
calcium, lipid levels should
be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients
(10 Years to 17
Years of Age)
17 Years of Age)
The recommended starting dose of atorvastatin calcium is 10 mg/day;
the usual dose
range is 10 to 20 mg orally once daily [see Clinical Studies (14.6)].
Doses should be
individualized according to the recommended goal of therapy [see
Indications and Usage
(1.2) and Clinical Pharmacology (12)]. Adjustments should be made at
intervals of 4
weeks or more.
2.3 Homozygous Familial Hypercholesterolemia
The dosage of atorvastatin calcium in patients with HoFH is 10 to 80
mg daily.
Atorvastatin calcium should be used as an adjunct to other
lipid-lowering treatments
(e.g., LDL apheresis) in these patients or if such treatments are
unavailable.
2.4 Concomitant Lipid-Lowering Therapy
Atorvastatin calcium may be used with bile acid resins. The
combination of HMG-CoA
reductase inhibitors (statins) and fibrates should generally be used
with caution [see
Warnings and Precautions (5.1) and Drug Interactions (7)].
2.5 Dosage in Patients with Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C
reduction of
atorvastatin calcium tablets; thus, dosage adjustment in patients with
renal dysfunction
is not nec