Country: United States
Language: English
Source: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
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 Rosuvastati
Rosuvastatin calcium tablets are supplied as: Bottle of 30 tablets NDC 71205-008-30 Bottle of 60 tablets NDC 71205-008-60 Bottle of 90 tablets NDC 71205-008-90 Storage Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED PROFICIENT RX LP ---------- 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 ERROR! HYPERLINK REFERENCE NOT VALID. 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): • 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 ACCORD HEALTHCARE INC. AT 1-866-941- 7875 OR WWW.ACCORD-HEALTHCARE.COM OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch. 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 have not been studied in Fredrickson Type I and V dyslipidemias. Rosuvastatin calcium tablet 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) 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 do Read the complete document