ROSUVASTATIN CALCIUM tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharmaceuticals 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 tablets are contraindi

Product summary:

Rosuvastatin tablets USP are supplied as: Rosuvastatin tablets USP, 5 mg are yellow colored, round, biconvex, film coated tablets debossed with '79' on one side and plain on other side. Bottles of 30                           NDC 13668-179-30 Bottles of 90                           NDC 13668-179-90 Bottles of 500                         NDC 13668-179-05 Rosuvastatin tablets USP, 10 mg are light pink colored, round, biconvex, film coated tablets debossed with '1180' on one side and plain on other side. Bottles of 30                           NDC 13668-180-30 Bottles of 90                           NDC 13668-180-90 Bottles of 500                         NDC 13668-180-05 Rosuvastatin tablets USP, 20 mg are light pink colored, round, biconvex, film coated tablets debossed with '1181' on one side and plain on other side. Bottles of 30                           NDC 13668-181-30 Bottles of 90                           NDC 13668-181-90 Bottles of 500                         NDC 13668-181-05 Rosuvastatin tablets USP, 40 mg are light pink colored, oval shape, biconvex, beveled edge, film coated tablets debossed with '1182' on one side and plain on other side. Bottles of 30                           NDC 13668-182-30 Bottles of 90                           NDC 13668-182-90 Bottles of 500                         NDC 13668-182-05 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 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, COATED
TORRENT PHARMACEUTICALS 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 tablets are 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 tablets, and
adjust dosage if necessary. (2.1)
_Adults_: Recommended dosage range is 5 to 40 mg once daily. (2.1)