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:

Glenmark Pharmaceutials Inc., USA

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rosuvastatin tablets are indicated: Rosuvastatin 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 the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of maj

Product summary:

Rosuvastatin Tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 5 mg Bottles of 30 with child-resistant closure 68462-261-30 Pink colored, film-coated, circular tablets debossed with “G” on one side and “C” on the other side. Bottles of 50 with child-resistant closure 68462-261-50 Bottles of 90 with child-resistant closure 68462-261-90 Bottles of 100 with child-resistant closure 68462-261-01 Bottles of 1000 68462-261-10 Carton unit-dose pack of 100 (10x10) 68462-261-11 10 mg Bottles of 30 with child-resistant closure 68462-262-30 Pink colored, film-coated, circular tablets debossed with “G” on one side and “D” on the other side. Bottles of 50 with child-resistant closure 68462-262-50 Bottles of 90 with child-resistant closure 68462-262-90 Bottles of 100 with child-resistant closure 68462-262-01 Bottles of 1000 68462-262-10 Carton unit-dose pack of 100 (10x10) 68462-262-11 20 mg Bottles of 30 with child-resistant closure 68462-263-30 Pink colored, film-coated, circular tablets debossed with “G” on one side and “O” on the other side Bottles of 50 with child-resistant closure 68462-263-50 Bottles of 90 with child-resistant closure 68462-263-90 Bottles of 100 with child-resistant closure 68462-263-01 Bottles of 1000 68462-263-10 Carton unit-dose pack of 100 (10x10) 68462-263-11 40 mg Bottles of 30 with child-resistant closure 68462-264-30 Pink colored, film-coated, oval shaped tablets debossed with “G264” on one side and “40” on the other side. Bottles of 50 with child-resistant closure 68462-264-50 Bottles of 90 with child-resistant closure 68462-264-90 Bottles of 100 with child-resistant closure 68462-264-01 Bottles of 500 68462-264-05 Bottles of 1000 68462-264-10 Storage Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); 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
GLENMARK PHARMACEUTIALS INC., USA
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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
INDICATIONS AND USAGE
Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin)
indicated: (1)
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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)
_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)
_Pediatric Patients with HoFH_: Recommended dosage is 20 mg once daily
for patients aged 7 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 tablets 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
Acute liver failure or decompensated cirrhosis. (4)
Hypersensitivity to rosuvastatin or any excipients in rosuvastatin
tablets. (4)
WARNINGS AND PRECAUTIONS
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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, Concomitan