Rovast

Each film-coated tablet contains: Rosuvastatin (as Calcium) 20 mg.

HMG CoA Reductase Inhibitor.
Pharmacology: Pharmacokinetics: Rosuvastatin is incompletely absorbed from the gastrointestinal tract, with an absolute bioavailability of about 20%. Peak plasma concentrations are achieved about 5 hours after an oral dose. It is taken up extensively by the liver, its primary site of action, and undergoes limited metabolism, mainly by the cytochrome P450 isoenzyme CYP2C9. It is about 90% bound to plasma proteins. The plasma elimination half-life of rosuvastatin is about 19 hours. About 90% of an oral dose of rosuvastatin appears in the faeces, including absorbed and non-absorbed drug, and the remainder is excreted in the urine; about 5% of a dose is excreted unchanged in urine.

Management of hyperlipidaemias, including primary hypercholesterolaemia (type IIa), mixed dyslipidaemia (type IIb), and hypertriglyceridaemia (type IV). It may also be used in patients with homozygous familial hypercholesterolaemia.

Rosuvastatin is given by mouth in an initial dose of 5 mg 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 daily is recommended in those taking ciclosporin, fibric acid derivatives, or nicotinic acid, and the risk of myopathy must be considered.

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 should be apprised of the potential hazard to the fetus.

Rosuvastatin should be used with caution in patients who have a history of liver disease and/or consume substantial quantities of alcohol. Statins should not be used in patients who already have unexplained persistently raised serum-aminotransferase concentrations and should be stopped if marked or persistent increases in serum-aminotransferase concentrations occur.
Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy, such as, renal impairment, advanced age and inadequately treated hyperthyroidism.
Rosuvastatin, being an HMG-CoA reductase inhibitor, effects 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, ciclosporin, 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.

Rosuvastatin's adverse effects 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.

The potential for drug-drug interactions with rosuvastatin is minimal since there is a minimal metabolism via CYP isoenzyme system.
Coadministration of ciclosporin or gemfibrozil, which both increase concentrations of rosuvastatin, thereby requiring a decrease in rosuvastatin dose when administered.

Store at temperatures not exceeding 30°C.
Protect from moisture.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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