Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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CRESTOR |
| Manufacturer |
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AstraZeneca Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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HMG-CoA reductase inhibitor. |
| Generic Name |
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Rosuvastatin (as calcium) 5mg, 10mg, 20mg, 40mg; tabs. |
| Indications |
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As an adjunct to diet in primary hyperlipidemia and mixed dyslipidemia (Types IIa and IIb) to reduce elevated total-C, LDL-C, apo B, non-HDL-C, and TG, and to increase HDL-C. Adjunct to diet in hypertriglyceridemia. Adjunct to other lipid-lowering treatments (or if these treatments are unavailable), in homozygous familial hypercholesterolemia to reduce LDL-C, total-C, and apo B. 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. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Take once daily. Primary hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia, slowing progression of atherosclerosis: initially 10mg; range 5–20mg; max 40mg (only if 20mg is insufficient); consider 5mg initially for Asians and others (see literature); consider 20mg initially if more aggressive therapy needed. Homozygous: initially 20mg; max 40mg. Concomitant cyclosporine: 5mg. Concomitant lopinavir/ritonavir: 10mg. Concomitant gemfibrozil: max 10mg. Severe renal impairment (CrCl ≤30mL/min) not on hemodialysis: initially 5mg; max 10mg. |
| Contraindications |
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Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Monitor liver function before therapy, at 12 weeks after starting or dose increases, then periodically; reduce dose or discontinue if serum transaminase levels >3xULN persist. History of liver disease or heavy alcohol ingestion. Discontinue if myopathy or elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Advise patients to report symptoms of myopathy or liver or renal toxicity (see literature). Severe renal insufficiency. Hypothyroidism (if undertreated). Elderly. |
| Interactions |
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Avoid gemfibrozil. Increased risk of myopathy with niacin, cyclosporine, lopinavir/ritonavir, fibrates. Monitor anticoagulants. Caution with drugs that decrease levels or activity of steroid hormones. Separate dosing of antacids (give ≥2 hours after rosuvastatin). |
| Adverse Reactions |
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GI upset, myalgia, arthralgia, rash, lab abnormalities (eg, thyroid function, alkaline phosphatase, hyperglycemia); rare: elevated ALT/AST, myopathy, rhabdomyolysis w. renal failure, jaundice. |
| How Supplied |
Tabs 5mg, 10mg, 20mg—90
40mg—30 |
| Additional Resources |
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• Related Prescribing Note |
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