Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Jubilant Cadista Pharmaceuticals Inc.
ROSUVASTATIN CALCIUM
ROSUVASTATIN 5 mg
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 is contraindicated in the following conditions: - Patients with a known hypersen
Rosuvastatin calcium tablets are supplied as: 5 mg: Yellow colored, round, biconvex tablet, debossed with ‘W’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure NDC 59746-428-30 Bottle of 90’s with child-resistant closure NDC 59746-428-90 Bottle of 100’s with child-resistant closure NDC 59746-428-01 Bottle of 1000’s NDC 59746-428-10 10 mg: Pink colored, round, biconvex tablet, debossed with ‘X’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure NDC 59746-429-30 Bottle of 90’s with child-resistant closure NDC 59746-429-90 Bottle of 100’s with child-resistant closure NDC 59746-429-01 Bottle of 1000’s NDC 59746-429-10 20 mg: Pink colored, round, biconvex tablet, debossed with ‘I1’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure NDC 59746-430-30 Bottle of 90’s with child-resistant closure NDC 59746-430-90 Bottle of 100’s with child-resistant closure NDC 59746-430-01 Bottle of 1000’s NDC 59746-430-10 40 mg: Pink colored, oval shaped, biconvex tablet, debossed with ‘I2’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure NDC 59746-431-30 Bottle of 90’s with child-resistant closure NDC 59746-431-90 Bottle of 100’s with child-resistant closure NDC 59746-431-01 Bottle of 1000’s NDC 59746-431-10 Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM - ROSUVASTATIN CALCIUM TABLET, FILM COATED JUBILANT CADISTA PHARMACEUTICALS INC. ---------- 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 is 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 has 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) (3) CONTRAINDICATIONS • • • • 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, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin calcium if signs or symptoms appear. (5.1, 7.5, 7.6) LIVER ENZYME ABNORMALITIES: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.2) ADVERSE REACTIONS Most frequent adverse reactions (rate ≥ 2%) are headache, myalgia, abdominal pain, asthenia, and nausea. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JUBILANT CADISTA PHARMACEUTICALS INC. AT 1-800-3 Lees het volledige document