ROSUVASTATIN CALCIUM tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Cadila Pharmaceuticals Limited

INN (इंटरनेशनल नाम):

ROSUVASTATIN CALCIUM

रचना:

ROSUVASTATIN 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 know

उत्पाद समीक्षा:

 Rosuvastatin calcium tablets are supplied as:  Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ROSUVASTATIN CALCIUM - ROSUVASTATIN CALCIUM TABLET, FILM COATED
CADILA PHARMACEUTICALS LIMITED
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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
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 calcium is an HMG Co‑A reductase inhibitor indicated
for: (1)
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 has not been studied in
Fredrickson Type I and V
dyslipidemias. (1)
DOSAGE AND ADMINISTRATION
· Rosuvastatin calcium tablets can be taken with or without food, at
any time of day. (2.1) (2)
· 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) (2)
· Adult HoFH: Starting dose 20 mg/day (2.1) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
· Known hypersensitivity to product components (4) (4)
· Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels
(4) (4)
· Pregnancy (4, 8.1, 8.3) (4)
· Lactation (4, 8.2) (4)
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