ROSUVASTATIN CALCIUM- rosuvastatin calcium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rosuvastatin calcium tablets are indicated as an adjunct to diet to: ●       reduce LDL-C, Total-C, non-HDL-C and Apo-B in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis). Pediatric use information for patients ages 8 to less than 10 years 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 calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavaila

Product summary:

Rosuvastatin calcium tablets are supplied as: 5 mg tablets: yellow, round convex shaped coated tablets with “RU5” on one side and blank on the other side. NDC 16252-615-30 bottles of 30 NDC 16252-615-90 bottles of 90 NDC 16252-615-50 bottles of 500 10 mg tablets: pink, round convex shaped coated tablets with “RU10” on one side and blank on the other side. NDC 16252-616-30 bottles of 30 NDC 16252-616-90 bottles of 90 NDC 16252-616-50 bottles of 500 20 mg tablets: pink, round convex shaped coated tablets with “RU20” on one side and blank on the other side. NDC 16252-617-30 bottles of 30 NDC 16252-617-90 bottles of 90 NDC 16252-617-50 bottles of 500 40 mg tablets: pink, oval shaped coated tablets with “RU40” on one side and blank on the other side. NDC 16252-618-30 bottles of 30 NDC 16252-618-90 bottles of 90 NDC 16252-618-50 bottles of 500 Storage Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor
indicated for:
pediatric patients 7 to 17 years of age with homozygous familial
hypercholesterolemia (HoFH) to reduce LDL-C, total-C,
non-HDL-C and Apo-B as an adjunct to diet, either alone or with other
lipid-lowering treatments ( 1.2)
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 calcium tablets have 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 mg to 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)
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of
age ( 2.2)
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 (greater than or equal to 65), hypothyroidism, renal impairment,
and combination use with cyclosporine,
atazanavir/ritonavir, lopinavir/ritonavir, or