Zocor: Advanced Cholesterol Management for Cardiovascular Risk Reduction
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Synonyms | |||
Zocor (simvastatin) is a prescription medication belonging to the statin class, specifically formulated to manage elevated cholesterol levels and significantly reduce the risk of major cardiovascular events. It functions by inhibiting HMG-CoA reductase, a key enzyme in the hepatic synthesis of cholesterol, thereby lowering low-density lipoprotein (LDL) cholesterol, triglycerides, and apolipoprotein B, while moderately increasing high-density lipoprotein (HDL) cholesterol. Clinical evidence supports its efficacy in both primary and secondary prevention settings, making it a cornerstone in lipid-lowering therapy for appropriate patient populations under strict medical supervision.
Features
- Active ingredient: Simvastatin
- Available in tablet strengths: 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg
- Administration: Oral, once daily in the evening or as directed
- Mechanism: Competitive inhibition of HMG-CoA reductase
- Bioavailability: Approximately 5% following oral administration
- Half-life: 1.9 hours for simvastatin; 1.3 hours for active metabolites
- Protein binding: >95% to human plasma proteins
- Metabolism: Hepatic, primarily via CYP3A4 isoenzyme
- Excretion: 13% urinary, 60% fecal
Benefits
- Significantly reduces LDL cholesterol levels by 30-50% depending on dosage
- Lowers triglyceride concentrations and modestly raises HDL cholesterol
- Demonstrates proven reduction in risk of coronary heart disease mortality
- Decreases incidence of non-fatal myocardial infarction and stroke
- May slow progression of coronary atherosclerosis
- Reduces need for revascularization procedures in appropriate patients
Common use
Zocor is primarily indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, and apolipoprotein B in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also approved to reduce the risk of total mortality by reducing coronary death, non-fatal myocardial infarction, and stroke in patients at high risk of coronary events due to existing coronary heart disease, diabetes, peripheral vessel disease, or history of stroke. Additionally, it is used to reduce the risk of revascularization procedures in hypercholesterolemic patients. The medication may be prescribed for heterozygous familial hypercholesterolemia in pediatric patients aged 10 years and older after failure of adequate trial of diet therapy.
Dosage and direction
The recommended starting dose for most patients is 10-20 mg once daily in the evening. For patients requiring LDL cholesterol reduction >45%, a starting dose of 40 mg may be considered. The maximum recommended dose is 40 mg daily, except in patients who have been taking simvastatin 80 mg chronically without evidence of muscle toxicity, who may continue therapy. The 80 mg dose is associated with increased risk of myopathy and should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle toxicity. Dosage adjustments are necessary when co-administered with certain medications that inhibit CYP3A4. For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once daily in the evening, with a maximum recommended dose of 40 mg daily.
Precautions
Liver function tests should be performed before initiating therapy and thereafter as clinically indicated. Patients who develop increased transaminase levels should be monitored until abnormalities resolve. Use with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Muscle toxicity, including myopathy and rhabdomyolysis, may occur and risk increases with higher doses and concomitant use of certain medications. Patients should be advised to report unexplained muscle pain, tenderness, or weakness promptly, particularly if accompanied by malaise or fever. HbA1c and fasting serum glucose levels may increase with statin use. Cognitive impairment (e.g., memory loss, confusion) has been reported with statin use, though generally not serious and reversible upon discontinuation.
Contraindications
Zocor is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing products) is contraindicated. Concomitant administration with gemfibrozil, cyclosporine, or danazol is contraindicated. The medication is contraindicated in pregnancy and breastfeeding due to potential fetal harm and excretion in breast milk. Hypersensitivity to any component of this medication constitutes a contraindication.
Possible side effect
Common adverse reactions (≥2% and > placebo) include headache, abdominal pain, constipation, and nausea. Musculoskeletal events include myalgia (1.5-3.6%), arthralgia (2.6-5.0%), and muscle cramps (0.6-1.1%). Elevated liver enzymes (AST/ALT >3x ULN) occur in approximately 1% of patients at higher doses. Less common but serious adverse effects include myopathy (0.02-0.9%), rhabdomyolysis (0.02-0.4%), hepatitis, pancreatitis, peripheral neuropathy, memory impairment, and hypersensitivity reactions including anaphylaxis. Laboratory abnormalities may include elevated creatine phosphokinase, transaminases, alkaline phosphatase, and γ-glutamyl transpeptidase.
Drug interaction
Strong CYP3A4 inhibitors significantly increase simvastatin exposure and risk of myopathy/rhabdomyolysis (contraindicated). Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, dronedarone) increase simvastatin exposure—do not exceed 10 mg simvastatin daily. Gemfibrozil (contraindicated) and other fibrates increase risk of myopathy—use with fenofibrate only with close monitoring. Niacin (>1 g/day) may increase risk of myopathy. Cyclosporine (contraindicated) increases simvastatin exposure approximately 3-4 fold. Warfarin: monitor INR as simvastatin may potentiate anticoagulant effect. Digoxin: modest increase in digoxin concentrations possible. Colchicine: increased risk of myopathy. Amiodarone, amlodipine, ranolazine: do not exceed 20 mg simvastatin daily.
Missed dose
If a dose is missed, patients should take it as soon as they remember, unless it is nearly time for the next scheduled dose. In such cases, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. Consistency in administration is important for maintaining stable cholesterol control, but occasional missed doses are unlikely to significantly impact long-term efficacy. Patients should maintain their prescribed dietary and lifestyle modifications regardless of dosing schedule adherence.
Overdose
There is no specific antidote for simvastatin overdose. In the event of overdose, treatment should be symptomatic and supportive. Liver function and CK levels should be monitored. The dialyzability of simvastatin and its metabolites is poor due to extensive protein binding. Cases of overdose have been reported with doses up to 3.6 grams; these were generally without symptoms or with mild gastrointestinal disturbances. However, the risk of severe adverse effects such as rhabdomyolysis, liver enzyme elevations, and renal failure increases with overdose. Patients presenting with overdose should receive appropriate supportive care with attention to potential musculoskeletal, hepatic, and renal complications.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep container tightly closed and protect from light and moisture. Keep out of reach of children and pets. Do not store in bathroom cabinets where humidity and temperature fluctuations may occur. Discard any unused medication after the expiration date printed on the packaging. Do not flush medications down the toilet or pour into drain unless instructed to do so. Proper disposal through medication take-back programs is recommended.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Zocor is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual patient responses and appropriate dosing may vary based on specific health conditions, concomitant medications, and other factors. Patients should not initiate, adjust, or discontinue medication without consulting their healthcare provider. The complete prescribing information should be reviewed before initiating therapy. Safety and effectiveness in pediatric patients below 10 years old have not been established.
Reviews
Clinical trials demonstrate that Zocor produces significant LDL cholesterol reductions of 28-46% at doses of 10-40 mg daily. The Heart Protection Study (n=20,536) showed simvastatin 40 mg reduced major vascular events by 24% (p<0.0001) in high-risk patients. The Scandinavian Simvastatin Survival Study (4S) demonstrated 30% reduction in total mortality (p=0.0003) in patients with coronary heart disease. Tolerability profile is generally favorable, with discontinuation rates due to adverse events similar to placebo in most studies. Real-world evidence supports maintained efficacy and safety with long-term use in appropriate patient populations. Specialist consensus guidelines continue to include simvastatin among recommended statin therapies for lipid management and cardiovascular risk reduction.