ATORVASTATIN CALCIUM tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Blenheim Pharmacal, Inc.

INN (Alþjóðlegt nafn):

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

Samsetning:

ATORVASTATIN 40 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin. 10 mg tablets Atorvastatin calcium tablets, 10 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side.  Bottles of 30 (NDC 60505-2578-3) Bottles of 90 (NDC 60505-2578-9) Bottles of 500 (NDC 60505-2578-5) Bottles of 1,000 (NDC 60505-2578-8) Bottles of 5,000 (NDC60505-2578-7) Blister of 100 (NDC 60505-2578-0) 20 mg tablets Atorvastatin calcium tablets, 20 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side.  Bottles of 30 (NDC 60505-2579-3) Bottles of 90 (NDC 60505-2579-9) Bottles of 500 (NDC 60505-2579-5) Bottles of 1,000 (NDC 60505-2579-8) Bottles of 5,000 (NDC 60505-2579-7) Blister of 100 (NDC 60505-2579-0) 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 60505-2580-3) Bottles of 90 (NDC 60505-2580-9) Bottles of 500 (NDC 60505-2580-5) Bottles of 1,000 (NDC 60505-2580-8) Bottles of 4,000 (NDC 60505-2580-7) Blister of 100 (NDC 60505-2580-0)  80 mg tablets Atorvastatin calcium tablets, 80 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side.  Bottles of 30 (NDC 60505-2671-3) Bottles of 90 (NDC 60505-2671-9) Bottles of 500 (NDC60505-2671-5) Bottles of 1,000 (NDC 60505-2671-8) Bottles of 2,500 (NDC 60505-2671-7) Blister of 100 (NDC 60505-2672-0)  Storage Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight container [see USP].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
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:
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 has 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
Atorvastatin calcium tablets 10 mg, 20 mg, 40 mg, and 80 mg tablets
(