Atorvastatin 80 mg & Ezetimibe 10 mg | ATOVASTRIN EZ 80/10

Description

ATOVASTRIN EZ 80/10 is a potent, fixed-dose combination therapy comprising Atorvastatin 80 mg and Ezetimibe 10 mg, meticulously formulated to provide dual-action lipid-lowering effects. This advanced cardiovascular therapy is specifically designed for patients with hyperlipidemia, mixed dyslipidemia, and those at high risk of cardiovascular events who require aggressive LDL-C reduction. By combining a high-intensity statin (Atorvastatin) with a cholesterol absorption inhibitor (Ezetimibe), ATOVASTRIN EZ 80/10 delivers a synergistic mechanism of action, ensuring more comprehensive and sustained control of elevated cholesterol levels than monotherapy alone. Composition: Each film-coated tablet contains: Atorvastatin Calcium IP equivalent to Atorvastatin 80 mg Ezetimibe IP 10 mg Excipients: q.s. Colour: Approved color used in pharmaceutical formulations. Mechanism of Action: Atorvastatin (80 mg): Atorvastatin is a selective, competitive HMG-CoA reductase inhibitor, the rate-limiting enzyme in the cholesterol biosynthesis pathway. By inhibiting this enzyme, Atorvastatin reduces hepatic cholesterol synthesis, leading to upregulation of LDL receptors on hepatocyte surfaces and enhanced clearance of LDL-C (low-density lipoprotein cholesterol) from the bloodstream. At the high-intensity dose of 80 mg, Atorvastatin has been clinically shown to reduce LDL-C by more than 50%. Ezetimibe (10 mg): Ezetimibe acts at the brush border of the small intestine to selectively inhibit the absorption of cholesterol and related phytosterols. Unlike statins, which reduce cholesterol synthesis, Ezetimibe targets dietary and biliary cholesterol absorption, complementing the action of Atorvastatin. This dual inhibition results in an additive lipid-lowering effect. Therapeutic Indications: ATOVASTRIN EZ 80/10 is indicated for: Primary Hypercholesterolemia (heterozygous familial and non-familial) Mixed Dyslipidemia Homozygous Familial Hypercholesterolemia (as an adjunct to other lipid-lowering therapies) Prevention of Cardiovascular Events in patients at high risk (e.g., with diabetes, prior cardiovascular events, or multiple risk factors) Patients not adequately controlled with statin monotherapy Clinical Benefits: Superior LDL-C Reduction: Provides >60% reduction in LDL-C when used in combination Target Achievement: Helps achieve aggressive lipid targets recommended by international guidelines (e.g., ESC/EAS, ACC/AHA) Dual Mechanism: Inhibits both cholesterol synthesis and absorption Reduced Atherosclerotic Risk: Slows progression of atherosclerosis and lowers risk of myocardial infarction, stroke, and other CV events Once-daily Convenience: Improves patient compliance with single-tablet formulation Dosage & Administration: Route: Oral Recommended Dose: One tablet daily, preferably in the evening, with or without food Adjustments: Dose should be individualized based on patient lipid levels, therapeutic response, and risk profile. Regular monitoring of lipid parameters is advised. Contraindications: Hypersensitivity to Atorvastatin, Ezetimibe, or any excipients Active liver disease or unexplained persistent elevations in hepatic transaminases Pregnancy and lactation Concurrent use with certain drugs that increase the risk of myopathy/rhabdomyolysis (e.g., strong CYP3A4 inhibitors) Warnings & Precautions: Liver Function: Monitor liver enzymes prior to initiation and periodically thereafter Muscle Effects: Monitor for symptoms of myopathy; assess CK levels if clinically indicated Renal Impairment: Use with caution in patients with severe renal dysfunction Drug Interactions: Use cautiously with fibrates, anticoagulants, and immunosuppressants Adverse Effects: Common adverse events include: Headache Myalgia or muscle cramps Gastrointestinal disturbances (nausea, diarrhea) Elevated liver enzymes Fatigue Serious but rare effects: Rhabdomyolysis Hepatotoxicity Hypersensitivity reactions