ROSUVASTATIN CALCIUM tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 5 mg

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 tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.  Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin 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 tablets have 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 produc

Product summary:

Rosuvastatin tablets USP are supplied as: Rosuvastatin tablets USP, 5 mg are yellow colored, round, biconvex, film coated tablets debossed with '79' on one side and plain on other side. NDC: 63629-7158-1: 30 Tablets in a BOTTLE NDC: 63629-7158-2: 90 Tablets in a BOTTLE NDC: 63629-7158-3: 28 Tablets in a BOTTLE NDC: 63629-7158-4: 60 Tablets in a BOTTLE NDC: 63629-7158-5: 100 Tablets in a BOTTLE Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, COATED
BRYANT RANCH PREPACK
----------
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
Dosage and Administration, Use with Concomitant Therapy ( 2.4) 5/2020
Warning and Precautions, Skeletal Muscle Effects ( 5.1) 5/2020
Warning and Precautions, Immune-Mediated Necrotizing Myopathy ( 5.2)
9/2020
INDICATIONS AND USAGE
Rosuvastatin 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 tablets have not been studied in Fredrickson Type I and V
dyslipidemias.
DOSAGE AND ADMINISTRATION
Rosuvastatin tablets 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, darolutamide, regorafenib, certain anti-viral medicines
or their combinations. Cases of
myopathy and rhabdomyolysis with acute renal failure secondary to
myoglobinuri