ATORVASTATIN CALCIUM- atorvastatin calcium tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Preferred Pharmaceuticals, Inc.

INN (שם בינלאומי):

ATORVASTATIN CALCIUM TRIHYDRATE

הרכב:

atorvastatin 80 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 calci

leaflet_short:

Atorvastatin calcium tablets of 80 mg are white to off-white, oval shaped, biconvex, film coated tablets  debossed ‘RDY’ on one side and ‘124’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s. Bottle of 30 - 68788-9983-3 Bottle of 60 - 68788-9983-6 Bottle of 90 - 68788-9983-9 Bottle of 100 - 68788-9983-1 Storage Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATORVASATATIN 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 tablet is an inhibitor of HMG-CoA reductase
(statin) indicated as an adjunct therapy to diet to:
8.
9.
10.
11.
12.
13.
14.
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
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, fibrates, 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: Persistent elevations in hepatic
tran