InnoGen Pharmaceuticals


InnoGen Pharmaceuticals
Full Prescribing Info
Rosuvastatin calcium.
Each tablet contains: Rosuvastatin (as calcium) 10 mg and 20 mg.
Rosuvastatin is a hydrochloride agent; it is a competitive inhibitor of 3-hydroxy-3methylglutaryl coenzyme A reductase (HMG-CoA reductase), the rate determining enzyme for synthesis HMG-CoA reductase inhibitions (sometimes called "statins") reduce total cholesterol. Low density lipoprotein (LDL)-cholesterol, and very low density lipoprotein (VLDL) cholesterol concentration in plasma. They also tend to reduce triglycerides and to increase high-density lipoprotein (HDL)-cholesterol concentrations. They are considered to exert their hypocholesterolaemic action by stimulating and increase in LDL-receptors on hepatocyte membranes thereby increasing the clearance of LDL from the circulation.
Pharmacology: Pharmacokinetics: Rosuvastatin is absorbed from the gastrointestinal tract and hydrolyzed to its active β-hydroxyacid form. Other active metabolites have been detected and a number of inactive metabolites are also formed Rosuvastatin undergoes extensive first-pass metabolism in the liver, its primary site of action. Less than 5% of the oral dose have been reported to reach the circulation as active metabolites. Both Rosuvastatin and its β-hydroxyacid metabolites are about 95% bound to plasma proteins. It is mainly excreted in the feces via the bile as metabolites. About 10% to 15% is recovered in the urine, mainly inactive forms. The half-life of the active metabolites is 1.9 hours.
Used to reduce LDL-cholesterol, apolipoprotein B, triglycerides and to increase HDL-cholesterol in the management of hyperlipidemias, including primary hypercholesterolemia (type IIa), mixed dyslipidemia (type IIb), and hypertriglyceridemia (type IV); also used in patients with homozygous familial hypercholesterolemia.
Dosage/Direction for Use
The dosage range for Rosuvastatin (as calcium) is 5 mg to 40 mg orally once daily. The usual starting dose is 10-20 mg. The drug may be administered as a single dose at any time of day, with or without food.
Statins are generally contra-indicated in pregnancy since there is a possibility that they might affect fetal sterol synthesis whereas the risk to the mother from stopping treatment temporarily is usually very low. It should not be given to patients at high risk of myopathy, including those receiving fibrates; use with ciclosporin is contra-indicated.
Special Precautions
Rosuvastatin should not be given with patients with acute liver diseases or unexplained persistent raised serum-aminotransferase concentrations. It should be avoided during pregnancy since there is a possibility that it could interfere with fetal sterol synthesis; there have been a few reports of congenital abnormalities associated with HMG-CoA interfere inhibitors. It should be discontinued if marked increases in serum-aminotransferase or creatinine phospokinase concentrations occur.
Adverse Reactions
The most common adverse effects of the therapy with Rosuvastatin and other HMG-CoA reductase inhibitors are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision and dysgeusia reversible increase in serum-aminotransferase concentrations may occur and liver functions should be monitored. Myopathy characterized by myalgia and muscle weakness and associated with increase creatinine phosphokinase concentrations, has been reported specially in patients taking Rosuvastatin concurrently with immunosuppressive drugs, fibric acid derivatives or nicotinic acid. Rarely rhabdomyolysis with acute renal failure may develop.
Store at temperature not exceeding 30°C.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
FC tab 10 mg x 30's. 20 mg x 30's.
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