Each film coated tablet contains: Rosuvastatin Calcium equivalent to Rosuvastatin 20 mg,
Excipients/Inactive Ingredients: q.s.
Colors: Titanium Dioxide BP & Red Oxide of Iron.
Pharmacology: Rosuvastatin Tablet is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. The primary site of action of rosuvastatin is the liver, the target organ for cholesterol lowering. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
Rosuvastatin Tablet is indicated for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia resistant to dietary measures, and as an adjunct to other lipid lowering treatments in homozygous familial hypercholesterolaemia.
The recommended start dose is 10 mg orally once daily and the majority of patients are controlled at this dose. A dose adjustment to 20 mg can be made after 4 weeks, if necessary. A doubling of the dose to 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk
There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit.
Rosuvastatin Tablet is contraindicated: In patients with hypersensitivity to rosuvastatin or any other ingredient of the product.
In patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).
In patients with severe renal impairment (creatinine clearance <30 ml/min).
In patients with myopathy.
In patients receiving concomitant cyclosporin.
Rosuvastatin Tablet should not be used 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, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures).
Effects on Ability to Drive and Use Machines: When driving vehicles or operating machines, it should be taken into account that dizziness may occur during treatment.
Rosuvastatin Tablet is contraindicated in pregnancy.
If a patient becomes pregnant during use of this product, treatment should be discontinued immediately.
Lactation: Rosuvastatin Tablet is contraindicated during lactation. There are no data with respect to excretion in milk in humans.
The adverse events seen with rosuvastatin are generally mild and transient.
The general side effects as headache, dizziness, constipation, nausea, abdominal pain, asthenia, pruritus, rash and urticaria are observed.
Renal Effects: In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and has not been shown to be predictive of acute or progressive renal disease.
Skeletal muscle effects: Uncomplicated myalgia and myopathy have been reported in rosuvastatin-treated patients.
Liver Effects: A dose-related increase in transaminases has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient.
Cyclosporin: During concomitant treatment with rosuvastatin and cyclosporin, rosuvastatin AUC values were on average 7 times higher than those observed in healthy volunteers. Concomitant administration did not affect plasma concentration of cyclosporin.
Vitamin K antagonist: As with other HMG-CoA reductase inhibitors, the initiation of treatment of dosage up titration of rosuvastatin in patient treated concomitantly with vitamin K antagonist (eg, warfarin) may result in an increase in international normalized ratio. Discontinuation or down titration of rosuvastatin may result in a decrease in INR. In such situation, appropriate monitoring of INR is desirable.
Gemfibrozil: As with other HMG-CoA reductase inhibitors, concomitant use of rosuvastatin & gemfibrozil resulted in a 2-fold increase in rosuvastatin Cmax and AUC.
Antacid: The simultaneous dosing of rosuvastatin with an antacid suspension containing aluminium and magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%. This effect was mitigated when the antacid was dosed 2 hours after rosuvastatin. The clinical relevance of this interaction has not been studied.
Erythromycin: Concomitant use of rosuvastatin and erythromycin resulted in a 20% decrease in AUC0-t and a 30% decrease in Cmax of rosuvastatin. This interaction may be caused by the increase in gut motility caused by erythromycin.
Oral contraceptive/hormone replacement therapy (HRT): Concomitant use of rosuvastatin and an oral contraceptive resulted in an increase in ethinyl oestradiol and norgestrel AUC of 26% and 34%, respectively. These increased plasma levels should be considered when selecting oral contraceptive doses. There are no pharmacokinetic data available in subjects taking concomitant rosuvastatin and HRT and therefore a similar effect cannot be excluded. However, the combination has been extensively used in women in clinical trials and was well tolerated.
Other medicinal products: Based on data from specific interaction studies no clinically relevant interactions with digoxin or fenofibrate are expected. Gemfibrozil, other fibrates and lipid lowering doses (> 1g/day) of niacin (nicotinic acid) increase the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors, probably because they can produce myopathy when given alone.
Cytochrome P450 enzymes: Results from in vitro and in vivo studies show that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes. In addition, rosuvastatin is a poor substrate for these isoenzymes. No clinically relevant interactions have been observed between rosuvastatin and either fluconazole (an inhibitor of CYP2C9 and CYP3A4) or ketoconazole (an inhibitor of CYP2A6 and CYP3A4). Concomitant administration of itraconazole (an inhibitor of CYP3A4) and rosuvastatin resulted in a 28% increase in AUC of rosuvastatin.
This small increase is not considered clinically significant. Therefore, drug interactions resulting from cytochrome P450-mediated metabolism are not expected.
Store below 30°C in a dry place.
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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