ROSUVASTATIN CALCIUM tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)

थमां उपलब्ध:

Sandoz Inc

INN (इंटरनेशनल नाम):

ROSUVASTATIN CALCIUM

रचना:

ROSUVASTATIN 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin calcium tablets are indicated: Rosuvastatin calcium tablets are contraindicated in the following conditions: Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on th

उत्पाद समीक्षा:

Rosuvastatin calcium tablets are supplied as: 5 mg: Light brown, round, film-coated tablets with "RSV 5" debossed on one side. NDC 0781-5400-31, bottles of 30 tablets NDC 0781-5400-92, bottles of 90 tablets NDC 0781-5400-34, bottles of 3000 tablets NDC 0781-5400-13, carton of 100 tablets (10 x 10 Unit-dose) 10 mg: Brown, round, film-coated tablets with "RSV 10" debossed on one side. NDC 0781-5401-31, bottles of 30 tablets NDC 0781-5401-92, bottles of 90 tablets NDC 0781-5401-34, bottles of 3000 tablets NDC 0781-5401-13, carton of 100 tablets (10 x 10 Unit-dose) 20 mg: Brown, round, film-coated tablets with "RSV 20" debossed on one side. NDC 0781-5402-31, bottles of 30 tablets NDC 0781-5402-92, bottles of 90 tablets NDC 0781-5402-34, bottles of 3000 tablets NDC 0781-5402-13, carton of 100 tablets (10 x 10 Unit-dose) 40 mg: Brown, round, film-coated tablets with "RSV 40" debossed on one side. NDC 0781-5403-31, bottles of 30 tablets NDC 0781-5403-92, bottles of 90 tablets NDC 0781-5403-34, bottles of 3000 tablets NDC 0781-5403-13, carton of 100 tablets (10 x 10 Unit-dose) Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN CALCIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROSUVASTATIN CALCIUM
TABLETS.
ROSUVASTATIN CALCIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Contraindications, Pregnancy and Lactation (4) Removed 01/2023
Warnings and Precautions (5.2) 01/2023
Warnings and Precautions, Concomitant Coumarin Anticoagulants (5.4)
Removed 01/2023
INDICATIONS AND USAGE
Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor
(statin) indicated: (1)
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o
o
DOSAGE AND ADMINISTRATION
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiating rosuvastatin, and adjust
dosage if necessary. (2.1)
_Adults:_ Recommended dosage range is 5 to 40 mg once daily. (2.1)
_Pediatric Patients with HeFH: _Recommended dosage range is 5 to 10 mg
once daily for patients aged 8 to
less than 10 years of age, and 5 to 20 mg once daily for patients aged
10 years and older. (2.2)
_Asian Patients: _Initiate at 5 mg once daily. Consider risks and
benefits of treatment if not adequately
controlled at doses up to 20 mg once daily. (2.4)
_Patients with Severe Renal Impairment (not on hemodialysis):_
Initiate at 5 mg once daily; do not exceed
10 mg once daily. (2.5, 5.1, 8.6)
See full prescribing information for rosuvastatin dosage and
administration modifications due to drug
interactions. (2.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
To reduce the risk of stroke, myocardial infarction, and arterial
revascularization procedures in adults
without established coronary heart disease who are at increased risk
of cardiovascular (CV) disease
based on age, hsCRP ≥2 mg/L, and at least one additional CV risk
factor.
As an adjunct to diet to reduce LDL-C in adults with primary
hyp