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:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias. Rosuvastatin calcium tablets are contraindicated in the following conditions: - Patients with a known

Product summary:

Rosuvastatin calcium tablets are supplied as:          Bottle of 30 tablets             NDC 16729-284-10          Bottle of 90 tablets             NDC 16729-284-15          Bottle of 1000 tablets         NDC 16729-284-17          Bottle of 30 tablets             NDC 16729-285-10          Bottle of 90 tablets             NDC 16729-285-15          Bottle of 1000 tablets         NDC 16729-285-17          Bottle of 30 tablets             NDC 16729-286-10          Bottle of 90 tablets             NDC 16729-286-15          Bottle of 1000 tablets         NDC 16729-286-17          Bottle of 30 tablets             NDC 16729-287-10          Bottle of 90 tablets             NDC 16729-287-15          Bottle of 1000 tablets         NDC 16729-287-17 Storage Store at 20ºC to 25ºC (68ºF 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, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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:
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 tablet can be taken with or without food, at any
time of day. (2.1)
Dose range: 5 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)
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, atazanavir/ritonavir,
lopinavir/ritonavir, or simeprevir. Cases of myopathy and
rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported. Advise patients to promptly report
to their physician unexplained and/or persistent
muscle pain, tenderness, or weakness and discontinue rosuvastatin
calcium tablets if signs or symp