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:

Proficient Rx LP

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:  Risk Summary Rosuvastat

उत्पाद समीक्षा:

Rosuvastatin Calcium Tablets, 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side.          Bottles of 30                              NDC 63187-860-30          Bottles of 60                              NDC 63187-860-60          Bottles of 90                              NDC 63187-860-90           Rosuvastatin Calcium Tablets, 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side.          Bottles of 30                              NDC 63187-864-30             Bottles of 60                              NDC 63187-864-60          Bottles of 90                              NDC 63187-864-90 Rosuvastatin Calcium Tablets, 20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side.          Bottles of 30                              NDC 63187-865-30          Bottles of 60                              NDC 63187-865-60          Bottles of 90                              NDC 63187-865-90 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
PROFICIENT RX LP
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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
RECENT MAJOR CHANGES
Indications and Usage (1.2) 5/2016
Contraindications (4) 5/2016
INDICATIONS AND USAGE
Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor
indicated for:
•
•
•
Limitations of use (1.8): Rosuvastatin calcium tablets have not been
studied in Fredrickson Type I and V
dyslipidemias.
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
MOST FREQUENT ADVERSE REACTIONS (RATE ≥2%) ARE HEADACHE, MYALGIA,
ABDOMINAL PAIN,
ASTHENIA, AND NAUSEA. (6.1)TO REPORT SUSPECTED ADVERSE REACTIONS,
CONTACT CITRON
PHARMA LLC. AT 1-855-5-CITRON (1-855-524-8766) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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)
Rosuvastatin calcium 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. ERROR! HYPERLINK REFERENCE NOT
VALID.
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)
SKELETAL MUSCLE EFFECTS (E.G., MYOPATHY AND RHABDOMYOLYSIS): Risks
increase with use of
40 mg dose