ROSUVASTATIN CALCIUM tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Preferred Pharmaceuticals, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Rosuvastatin tablets are indicated: Rosuvastatin calcium is contraindicated in the following conditions: Risk Summary Discontinue rosuvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin calcium 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 identi

Ringkasan produk:

Rosuvastatin tablets, USP are supplied as:  Rosuvastatin tablets 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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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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
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)
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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 calcium, 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 calcium 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
calcium. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
MOST FREQUEN