ROSUVASTATIN CALCIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MSN LABORATORIES PRIVATE LIMITED

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rosuvastatin tablets are indicated: - 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: o Reduce LDL-C in adults with primary hyperlipidemia. o Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). - As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). - As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. Rosuvastatin calci

Product summary:

Rosuvastatin tablets, USP are supplied as: Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROSUVASTATIN CALCIUM - ROSUVASTATIN CALCIUM TABLET, FILM COATED
MSN LABORATORIES PRIVATE LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROSUVASTATIN TABLETS.
ROSUVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration Modifications Due to Drug Interactions (2.6)
07/2023
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 is an HMG Co-A reductase inhibitor (statin)
indicated: (1)
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
hyperlipidemia.
As an adjunct to diet to reduce low-density lipoprotein cholesterol
(LDL-C) and slow the progression of
atherosclerosis in adults.
As an adjunct to diet to reduce LDL-C in adults and pediatric patients
aged 8 years and older with
heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such
treatments are unavailable, to reduce
LDL-C in adults and pediatric patients aged 7 years and older with
homozygous familial
hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
o Primary dysbetalipoproteinemia.
o Hypertriglyceridemia.
DOSAGE AND ADMINISTRATION
Take orally with or without food, at any time of day. (2.1)
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiating rosuvastatin calcium, and
adjust dosage if necessary. (2.1)
_Adults:_ Recommended dosage range is 5 to 40 mg once daily. (2.1)
_Pediatric Patien