Product Description

Indications: Corestin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated Total Cholesterol (Total-C), LDL-C, ApoB, non-HDL-C, and triglycerides (TG), while increasing HDL-C levels. It is also indicated for hypertriglyceridemia, primary dysbetalipoproteinemia (Type III hyperlipoproteinemia), homozygous familial hypercholesterolemia (HoFH), slowing the progression of atherosclerosis, and reducing the risk of myocardial infarction (MI), stroke, and arterial revascularization procedures in high-risk patients without clinically evident coronary heart disease. In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia (HeFH), it is used to reduce elevated Total-C, LDL-C, and ApoB after failure of adequate diet therapy.Pharmacology: Rosuvastatin is a selective and competitive HMG-CoA reductase inhibitor that blocks the conversion of HMG-CoA to mevalonate, a precursor of cholesterol. It lowers cholesterol by increasing hepatic LDL receptors, which enhances uptake and breakdown of LDL cholesterol. It also reduces hepatic synthesis of VLDL, resulting in decreased VLDL and LDL particle levels.Dosage & Administration: In pediatric patients aged 10 to 17 years with HeFH, the usual dose ranges from 5-20 mg once daily, with a maximum dose of 20 mg/day. Dose adjustments should be made at intervals of 4 weeks or longer. For patients with very high cholesterol and high risk of MI or stroke, the recommended dose is 40 mg once daily. In homozygous familial hypercholesterolemia, the recommended starting dose is 20 mg once daily. Asian patients should generally start with 5 mg once daily. In severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis, therapy should start at 5 mg once daily and should not exceed 10 mg daily.When used with Cyclosporine, the dose should not exceed 5 mg daily. With Lopinavir/Ritonavir or Atazanavir/Ritonavir, the maximum recommended dose is 10 mg daily. Combination with Gemfibrozil should be avoided; if necessary, Rosuvastatin dose should not exceed 10 mg daily.Interaction: Cyclosporine significantly increases Rosuvastatin exposure, requiring dose limitation. Gemfibrozil should generally be avoided due to increased risk of muscle toxicity. Protease inhibitors such as Lopinavir/Ritonavir and Atazanavir/Ritonavir increase Rosuvastatin levels. Coumarin anticoagulants may prolong INR, requiring close monitoring. Concurrent use with fibrates or niacin may increase the risk of skeletal muscle effects.Contraindications: Corestin is contraindicated in patients with hypersensitivity to Rosuvastatin or any formulation component, active liver disease including unexplained persistent elevation of hepatic transaminases, pregnancy, women planning pregnancy, and breastfeeding mothers.Side Effects: Corestin is generally well tolerated. Common side effects include headache, myalgia, constipation, weakness, abdominal pain, nausea, fatigue, and muscle discomfort.Pregnancy & Lactation: Rosuvastatin should not be used during pregnancy or breastfeeding. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, the medication should be discontinued immediately.Precautions & Warnings: Corestin should be used cautiously in patients at risk of myopathy, including elderly patients above 65 years, patients with hypothyroidism, or renal impairment. The risk of muscle toxicity increases with concomitant use of fibrates, niacin, Gemfibrozil, Cyclosporine, or certain antiviral drugs. Therapy should be discontinued if markedly elevated creatine kinase levels occur or if myopathy is suspected. Liver function tests are recommended before treatment, 12 weeks after initiation or dose escalation, and periodically thereafter. Patients with acute serious conditions such as sepsis, dehydration, trauma, major surgery, or severe metabolic disorders may require temporary discontinuation of therapy.Overdose Effects: There is no specific antidote for Rosuvastatin overdose. Treatment should be symptomatic and supportive. Hemodialysis does not significantly increase Rosuvastatin clearance.Therapeutic Class: Statins; Other Anti-anginal & Anti-ischaemic drugs.Storage Conditions: Store below 30°C, protected from light and moisture. Keep out of reach of children.