Generic Name and Formulations:
Rosuvastatin (as calcium) 5mg, 10mg, 20mg, 40mg; tabs.
Company:
AstraZeneca Pharmaceuticals
Indications for CRESTOR:
As an adjunct to diet in primary hyperlipidemia and mixed dyslipidemia (Types IIa and IIb) to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG, and to increase HDL-C. Adjunct to diet in hypertriglyceridemia. Adjunct to diet in primary dysbetalipoproteinemia (Type III hyperlipoproteinemia). Adjunct to other lipid-lowering treatments (or if these treatments are unavailable), in homozygous familial hypercholesterolemia to reduce LDL-C, total-C, and ApoB. Adjunct to diet to slow the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C to target levels. To reduce risk of MI, stroke, or arterial revascularization procedures in patients without clinically evident CHD but with an increased risk of CVD based on age (men ≥50yrs, women ≥60yrs), hs-CRP ≥2mg/L, and at least one additional risk factor. Pediatric patients 10–17yrs of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy. Limitations of use: not studied in Fredrickson Type I and V dyslipidemias.
Adult Dose for CRESTOR:
Take once daily. Primary hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia, slowing progression of atherosclerosis, prevention of CVD: Dose range 5–40mg; usual starting dose 10–20mg; 40mg (only if 20mg is insufficient); consider 5mg initially for Asian patients (see full labeling). Homozygous: initially 20mg. Concomitant cyclosporine: max 5mg. Concomitant lopinavir/ritonavir or atazanavir/ritonavir: max 10mg. Concomitant niacin or fenofibrate: consider dose reduction. Concomitant gemfibrozil: avoid; if needed, max 10mg. Severe renal impairment (CrCl ≤30mL/min) not on hemodialysis: initially 5mg; max 10mg.
Children's Dose for CRESTOR:
<10yrs: not recommended. HeFH: 10–17yrs: usual range 5–20mg/day. Max 20mg/day. May adjust dose at ≥4 week intervals.
Pharmacological Class:
HMG-CoA reductase inhibitor.
Contraindications:
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Warnings/Precautions:
Discontinue if myopathy or elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Monitor liver function before starting therapy and as clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. History of liver disease or heavy alcohol ingestion. Severe renal insufficiency. Hypothyroidism (if undertreated). Elderly.
Interactions:
Avoid gemfibrozil. Increased risk of myopathy with niacin (>1g/day), fibrates, inhibitors of certain transporter proteins including OATP1B1 and BCRP (eg, cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir). Monitor anticoagulants. Caution with drugs that decrease levels or activity of steroid hormones. Separate dosing of antacids (give ≥2hrs after rosuvastatin).
Adverse Reactions:
Headache, myalgia, abdominal pain, asthenia, nausea; lab abnormalities (eg, thyroid function, alkaline phosphatase, hyperglycemia), proteinuria and hematuria (consider dose reduction if persistent), elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction, increased HbA1c and fasting serum glucose, rare: cognitive impairment, non-fatal hepatic failure, immune-mediated necrotizing myopathy.
How Supplied:
Tabs 5mg, 10mg, 20mg—90; 40mg—30
