ROSUVASTATIN CALCIUM tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aphena Pharma Solutions - Tennessee, LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Rosuvastatin is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. Rosuvastatin has not been studied in Fredrickson Type I and V dyslipidemias. Rosuvastatin is contraindicated in the following conditions: •           Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactio

Produkt oversigt:

Rosuvastatin calcium tablets are supplied as: NDC 51407-153-90: 5 mg. Pink, round, biconvex, coated tablets. Debossed as ‘CY’ on one side and ‘5’ on other side; bottle of 90 tablets NDC 51407-154-90: 10 mg. Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘10’ on other side; bottle of 90 tablets NDC 51407-155-90: 20 mg. Yellow, round, biconvex, coated tablets. Debossed as 'CY' on one side, and '20' on other side; bottle of 90 tablets NDC 51407-156-30: 40 mg. Pink, round, biconvex, coated tablet. Debossed as 'CY' on one side, and '40' on other side; bottle of 30 tablets Storage Store at controlled room temperature, 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ROSUVASTATIN CALCIUM TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN 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
Dosage and Administration, Use with Concomitant Therapy ( 2.4) 5/2020
Warning and Precautions, Skeletal Muscle Effects ( 5.1) 5/2020
INDICATIONS AND USAGE
Rosuvastatin is an HMG Co-A reductase inhibitor indicated for:
• adult patients with hypertriglyceridemia as an adjunct to diet (
1.3)
• adult patients with primary dysbetalipoproteinemia (Type III
hyperlipoproteinemia) as an adjunct to diet (
1.4)
• adult patients with homozygous familial hypercholesterolemia
(HoFH) to reduce LDL-C, total-C, and
ApoB ( 1.5)
Limitations of use ( 1.8): Rosuvastatin has not been studied in
Fredrickson Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
• Rosuvastatin calcium tablets can be taken with or without food, at
any time of day. ( 2.1)
• Dose range: 5-40 mg once daily. Use 40 mg dose only for patients
not reaching LDL-C goal with 20 mg. (
2.1)
• Adult HoFH: Starting dose 20 mg/day ( 2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg ( 3)
CONTRAINDICATIONS
• Known hypersensitivity to product components ( 4)
• Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels
( 4)
• Pregnancy ( 4, 8.1, 8.3)
• Lactation ( 4, 8.2)
WARNINGS AND PRECAUTIONS
• SKELETAL MUSCLE EFFECTS (E.G., MYOPATHY AND RHABDOMYOLYSIS): Risks
increase with use of 40
mg dose, advanced age (≥65), hypothyroidism, renal impairment, and
combination use with
cyclosporine, darolutamide, regorafenib, certain anti-viral medicines
or their combinations. Cases of
myopathy and rhabdomyolysis with acute renal failure seconda