ROSUVASTATIN CALCIUM tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Golden State Medical Supply, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Rosuvastatin calcium tablets is 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: - Reduce LDL-C in adults with primary hyperlipidemia. - Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. - 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: - Primary dysbetalipoproteinemia. - Hypertriglyceridemia. Rosuvastatin calcium tablets is contraindicated i

Povzetek izdelek:

Rosuvastatin calcium tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 90 tablets NDC 51407-153-90 Pink, round, biconvex, coated tablets. Debossed as ‘CY’ on one side and ‘5’ on other side 10 mg bottles of 90 tablets NDC 51407-154-90 Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘10’ on other side 20 mg bottles of 90 tablets NDC 51407-155-90 Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘20’ on other side 40 mg bottles of 30 tablets NDC 51407-156-30 Pink, round, biconvex, coated tablet. Debossed as ‘CY’ on one side, and ‘40’ on other side 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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ROSUVASTATIN CALCIUM TABLETS. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE
INFORMATION
NEEDED TO USEROSUVASTATIN 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 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:
Primary dysbetalipoproteinemia.
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 tablets,
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 dos