See related Crestor film-coated tab information |
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Manufacturer |
AstraZeneca |
Distributor |
DKSH |
Contents |
Rosuvastatin Ca |
Indications |
Prevention of CV events in adults w/ increased risk of atherosclerotic CV disease based on the presence of CV disease risk markers. Adjunct to diet in primary hypercholesterolaemia [type IIa including heterozygous familial hypercholesterolaemia (HeFH)], mixed dyslipidaemia (type IIb) & homozygous familial hypercholesterolaemia when response to diet, other lipid-lowering or nonpharmacological treatments are inadequate. Slow or delay the progression of atherosclerosis. Reduction of total cholesterol, LDL-C & Apo-B in patients w/ HeFH.
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Dosage |
Initially 5-10 mg once daily. May be adjusted to 20 mg after 2-4 wk if needed. Patients w/ severe hypercholesterolaemia at high CV risk 40 mg may be considered. Childn & adolescent 10-17 yr HeFH 5-20 mg once daily.
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Overdosage |
View Crestor overdosage for action to be taken in the event of an overdose. |
Administration |
May be taken with or without food |
Contraindications |
Active liver disease (including unexplained persistent elevations of serum transaminases & elevation >3x the ULN). Severe renal impairment (CrCl <30 mL/min). Myopathy. Patients receiving concomitant cyclosporin. Pregnancy & lactation.
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Special Precautions |
Proteinuria. Skeletal muscle effects eg uncomplicated myalgia, myopathy & rarely rhabdomyolysis. Predisposing factors for rhabdomyolysis or myopathy eg renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ other HMG-CoA reductase inhibitor or fibrate, alcohol abuse & age >70 yr. Acute, serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Excessive alcohol consumption & history of liver disease. Childn.
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Adverse Drug Reactions |
Headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia. Rarely pancreatitis, myopathy, rhabdomyolysis & angioedema. Pruritus, rash & urticaria (uncommon).
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Drug Interactions |
Cyclosporin, vit K antagonists, gemfibrozil, PIs, antacids (Al & Mg hydroxide), erythromycin, OC/hormone replacement therapy (HRT), other fibrates & niacin (lipid-lowering dose).
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Pregnancy Category (US FDA) |
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. |
Caution For Usage |
For caution against possible variation of physical aspect of medicine... click to view Crestor detailed prescribing infomation |
Storage |
View Crestor storage conditions for details to ensure optimal shelf-life. |
Description |
View Crestor description for details of the chemical structure and excipients (inactive components). |
Mechanism of Action |
View Crestor mechanism of action for pharmacodynamics and pharmacokinetics details. |
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