ATORVASTATIN CALCIUM tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Aphena Pharma Solutions - Tennessee, LLC

ІПН (Міжнародна Ім'я):

ATORVASTATIN CALCIUM TRIHYDRATE

Склад:

ATORVASTATIN 40 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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: In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calciu

Огляд продуктів:

Atorvastatin calcium tablets are supplied as follows: 10 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 10” on one side. Bottles contain desiccant. NDC 0781-5381-31, bottle of 30 tablets NDC 0781-5381-92, bottle of 90 tablets NDC 0781-5381-01, bottle of 100 tablets NDC 0781-5381-10, bottle of 1000 tablets NDC 0781-5381-34, bottle of 3000 tablets 20 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 20” on one side. Bottles contain desiccant. NDC 0781-5382-31, bottle of 30 tablets NDC 0781-5382-92, bottle of 90 tablets NDC 0781-5382-01, bottle of 100 tablets NDC 0781-5382-10, bottle of 1000 tablets NDC 0781-5382-34, bottle of 3000 tablets 40 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 40” on one side. Bottles contain desiccant. NDC 0781-5384-31, bottle of 30 tablets NDC 0781-5384-92, bottle of 90 tablets NDC 0781-5384-01, bottle of 100 tablets NDC 0781-5384-10, bottle of 1000 tablets NDC 0781-5384-22, bottle of 2000 tablets 80 mg, light yellow, dappled, glossy, oval biconvex film-coated tablets, debossed with “HLA 80” on one side. Bottles contain desiccant. NDC 0781-5388-31, bottle of 30 tablets NDC 0781-5388-92, bottle of 90 tablets NDC 0781-5388-01, bottle of 100 tablets NDC 0781-5388-10, bottle of 1000 tablets Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Atorvastatin calcium tablets are an inhibitor of HMG-CoA reductase
(statin) indicated as an adjunct therapy to diet to:
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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).
DOSAGE FORMS AND STRENGTHS
10, 20, 40, and 80 mg tablets (3).
CONTRAINDICATIONS
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels (4.1).
Women who are pregnant or may become pregnant (4.3).
Nursing mothers (4.4).
Hypersensitivity to any component of this medication (4.2).
WARNINGS AND PRECAUTIONS
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks
increase when higher doses are used concomitantly
with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin,
itraconazole, HIV protease inhibitors). Predisposing
factors include advanced age (> 65), uncontrolled hypothyroidism, and
renal impairment. Rare cases of rhabdomyolysis
with acute renal failure secondary to myoglobinuria have been
reported. Advise patients to promptly report to their
physician unexplained and/or persistent muscle pain, tenderness, or
weakness. Atorvastatin calcium therapy should be
discontinued if myopathy is diagnosed or suspected (5.1, 8.5).
Liver enzyme abnormalities: Persiste