Willore Pharma
Full Prescribing Info
Rosuvastatin calcium.
Each film-coated tablet contains: Rosuvastatin (as calcium) 10 mg.
Pharmacology: Pharmacokinetics: Peak plasma concentrations of rosuvastatin were reached 5 hours following oral dosing. The absolute bioavailability of rosuvastatin is approximately 20%.
Rosuvastatin is 90% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. Mean Volume of distribution at steady-state of rosuvastatin is approximately 134 liters.
Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 2C9. Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by Rosuvastatin in the parent compound.
Following oral administration, Rosuvastatin, and its metabolite are primarily excreted in feces (90%). The elimination half-life of Rosuvastatin is approximately 19 hours.
For the management of hyperlipidaemias, including primary hypercholesterolemia (type IIa), mixed dyslipidaemia (type IIb), and hypertriglyceridaemia (type IV), it may also be used in patients with homozygous familial hypercholesterolaemia.
Dosage/Direction for Use
Rosuvastatin is given by mouth in an initial dose of 5 to 10 mg in the evening; an initial dose of 20 mg may be used in patients with ischaemic heart disease. The dose may be adjusted at interval of not less than 4 weeks up to maximum of 80 mg once daily in three divided doses of 20 mg, 20 mg and an evening dose of 40 mg. A maximum of 10 mg once daily is recommended in those taking cyclosporine, fibric acid derivatives, or nicotinic acid, and the risk of myopathy must be considered. Or as prescribed by the physician.
Rosuvastatin is contraindicated in patients with a known hypersensitivity to any component of this product.
Rosuvastatin is also contraindicated in patients with active liver disease or with unexplained persistent elevations of serum transaminases.
It is also contraindicated during pregnancy and in nursing mothers.
If patient becomes pregnant while taking this drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus.
Special Precautions
Rosuvastatin should be used with caution in patients who have a history of liver disease and/or consume substantial quantities of alcohol. Unexplained persistent transaminase elevations or active liver disease are contraindications to the use of Rosuvastatin.
Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age and inadequately treated hypothyroidism.
As an HMG-CoA reductase inhibitors, effects of Rosuvastatin on skeletal muscle are uncomplicated myalgia and myopathy. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Rosuvastatin therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected.
The risk of myopathy during treatment with Rosuvastatin may be increased with concurrent administration of other lipid lowering therapies, cyclosporine, or lopinavir/ritonavir.
Rosuvastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis hypotension, dehydration, major surgery, trauma, severe metabolic endocrine, and electrolyte disorders, or uncontrolled seizures).
Combination therapy of Rosuvastatin and gemfibrozil should generally be avoided.
Adverse Reactions
Adverse effects of Rosuvastatin are generally mild and transient. However, the incidence of adverse drug reactions tend to increase with increasing dose. The common adverse effects of therapy are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia.
There is no specific treatment in an overdose of event. In case of overdosage, the patient should be treated symptomatically and supportive measures be instituted when necessary. Haemodialysis is unlikely to be of benefit.
Drug Interactions
The potential for drug-drug interactions with Rosuvastatin is minimal since there is a minimal metabolism via CYP isoenzyme system.
Coadministration of cyclosporine or gemfibrozil, which both increased concentrations of Rosuvastatin, thereby requiring a decrease in Rosuvastatin dose when administered
Store at temperature not exceeding 30°C.
Protect from moisture.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
FC tab 10 mg x 100's.
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