ROSUVASTATIN CALCIUM- rosuvastatin calcium tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aphena Pharma Solutions - Tennessee, LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Rosuvastatin calcium tablets are supplied as: Storage Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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 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
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ADVERSE REACTIONS
Most frequest adverse reactions (rate ≥2%) are headache, myalgia,
abdominal pain, asthenia, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIOCON PHARMA INC. AT
1-866-924-6266 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
FEMALES OF REPRODUCTIVE POTENTIAL: Advise females of reproductive
potential to use effective contraception during
treatment with rosuvastatin (8.3)
SEVERE RENAL IMPAIRMENT (NOT ON HEMODIALYSIS): Starting d