ROSUVASTATIN CALCIUM tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Sun Pharmaceutical Industries, Inc.

INN (Algemene Internationale Benaming):

ROSUVASTATIN CALCIUM

Samenstelling:

ROSUVASTATIN 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 i

Product samenvatting:

Rosuvastatin tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. 5 mg tablets: Yellow colored, circular, biconvex, film-coated tablets with ‘S’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure..........................................................NDC 47335-582-83 Bottles of 90 with child-resistant closure..........................................................NDC 47335-582-81 Bottles of 1000..................................................................................................NDC 47335-582-18 10 mg tablets: Pink colored, circular, biconvex, film-coated tablets with ‘583’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure ….........................................................NDC 47335-583-83 Bottles of 90 with child-resistant closure ….........................................................NDC 47335-583-81 Bottles of 1000 ………………………… ….........................................................NDC 47335-583-18 20 mg tablets: Pink colored, circular, biconvex, film-coated tablets with ‘584’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure..............................................................NDC 47335-584-83 Bottles of 90 with child-resistant closure..............................................................NDC 47335-584-81 Bottles of 1000…………………………..............................................................NDC 47335-584-18 40 mg tablets: Pink colored, oval, biconvex, film-coated tablets with ‘585’ debossed on one side and plain on the other side of the tablet. Bottles of 30 with child-resistant closure.............................................................NDC 47335-585-83 Bottles of 90 with child-resistant closure.............................................................NDC 47335-585-81 Bottles of 1000 ………………………….............................................................NDC 47335-585-18 Storage Store rosuvastatin tablets at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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 is an HMG Co-A reductase inhibitor (statin) indicated:
(1) (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. (1)
o Hypertriglyceridemia. (1)
(1)
DOSAGE AND ADMINISTRATION
Take orally with or without food, at any time of day. (2.1) (2)
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 P