ROSUVASTATIN CALCIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

A-S Medication Solutions

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 calcium is contraindicated in the following conditions: - Patients with a known hypersensitivity to any component of this

Product summary:

Product: 50090-6519 NDC: 50090-6519-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-6519-1 90 TABLET, FILM COATED in a BOTTLE NDC: 50090-6519-2 100 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                ROSUVASTATIN CALCIUM - ROSUVASTATIN CALCIUM TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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 has 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)
Preganancy (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
myoglobinuria have been report
                                
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