Creston is the preparation of rosuvastatin. It is a synthetic lipid-lowering agent, which is 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. It reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol. It also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG and increases ApoA-I. Rosuvastatin also lowers the LDL-C/HDL-C, total C/HDL-C and nonHDL-C/HDL-C and the ApoB/ApoA-I ratios
 

• Creston is indicated for patients with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and exercise is inadequate.
• It is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis).
   

Creston, may be given at any time of day, with or without food. The dose of rosuvastatin should be individualized according to the goal of therapy and patient's response.
Adult: The usual starting dose of rosuvastatin is, 10 mg once daily. If necessary dose can be adjusted to 20 mg after 4 weeks. Maximum 40 mg should only be considered in patients with severe hypercholesterolaemia (including those with familial hypercholesterolaemia) at high cardiovascular risk who do not achieve their treatment goal on 20 mg.
Children: Paediatric experience is limited to a small number of children (aged 8 years or above) with homozygous familial hypercholesterolaemia. Use in children should be supervised by specialists.
Dose adjustment is not necessary in elderly, and also in patients with mild to moderate hepatic and renal impairment.
 

Headache, dizziness, constipation, nausea, abdominal pain, connective tissue and bone disorders,
myalgia, myopathy, asthenia, in rare cases rhabdomyolysis.

Creston is contraindicated in patients with:

• Hypersensitivity to any component of this product.
•  Active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times of the upper limit of normal.
• Myopathy.
• Receiving concomitant cyclosporin.
• Severe renal impairment (creatinine clearance<30ml/min).
   

It should not be used during pregnancy or lactation as the safety of rosuvastatin during pregnancy and whilst breast-feeding has not been established.
 

• Severe hepatic impairment 
•  Renal impairment
• Hypothyroidism
• Family or personal history of hereditary muscle disorders
• Prior history of muscle toxicity to other statins or fibrates, alcohol abuse;
• Predisposing factors for rhabdomyolysis
• If creatinine kinase levels are significantly elevated (>5 times upper limit of normal)
   

Gemfibrozil; fibrates; nicotinic acid; cyclosporin; azole antifungals; macrolides; vitamin K antagonists, antacids, oral contraceptives
 

Store in a cool (below 30oc), dry place and protect from light. Keep out of reach of children
 

Creston-10: Box containing 1 strip of 10 tablets each. Each tablet contains rosuvastatin calcium INN equivalent to rosuvastatin 10 mg.



Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK