Zocor: Proven LDL Cholesterol Reduction for Cardiovascular Health
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Synonyms | |||
Zocor (simvastatin) is a leading HMG-CoA reductase inhibitor, commonly referred to as a statin, prescribed for the management of hypercholesterolemia and the reduction of cardiovascular risk. It functions by competitively inhibiting the enzyme HMG-CoA reductase, a critical rate-limiting step in the hepatic synthesis of cholesterol. This action effectively lowers serum concentrations of total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B, while moderately increasing high-density lipoprotein cholesterol (HDL-C). By addressing the lipid abnormalities associated with atherosclerosis, Zocor serves as a cornerstone in both primary and secondary prevention strategies for major cardiovascular events, supported by extensive clinical trial data demonstrating its efficacy and safety profile.
Features
- Active Pharmaceutical Ingredient: Simvastatin.
- Drug Class: HMG-CoA reductase inhibitor (statin).
- Available Dosage Strengths: 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg film-coated tablets.
- Mechanism of Action: Competitive inhibition of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis.
- Pharmacokinetics: Administered orally as an inactive lactone prodrug; hydrolyzed in vivo to the active β-hydroxyacid form. Extensive first-pass extraction in the liver, its primary site of action.
- Excretion: Primarily excreted via the hepatobiliary route, with renal excretion playing a minor role.
- Half-life: Approximately 2 hours for the active hydroxyacid metabolite.
Benefits
- Significant LDL-C Reduction: Demonstrably lowers low-density lipoprotein cholesterol (LDL-C), the primary target of lipid-modifying therapy, by 25% to 50% depending on dosage.
- Reduced Cardiovascular Event Risk: Proven in large-scale clinical trials to significantly decrease the risk of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and the need for revascularization procedures.
- Atherosclerosis Modification: Contributes to the slowing of atherosclerosis progression and can induce plaque regression in some patients, as evidenced by imaging studies.
- Favorable Effect on Other Lipid Parameters: Moderately increases high-density lipoprotein cholesterol (HDL-C) and reduces triglycerides, providing a comprehensive improvement in the overall lipid profile.
- Mortality Benefit in High-Risk Patients: Established role in secondary prevention, reducing coronary heart disease mortality and total mortality in patients with a history of cardiovascular disease.
- Well-Established Safety Profile: Decades of post-marketing surveillance and clinical use provide a robust understanding of its benefit-risk ratio.
Common use
Zocor is indicated as an adjunct to diet and lifestyle modifications for several clinical scenarios. Its primary use is to reduce elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) or mixed dyslipidemia. Furthermore, it is indicated to reduce the risk of total mortality by reducing coronary death, to reduce the risk of non-fatal myocardial infarction and stroke, and to reduce the need for coronary and non-coronary revascularization procedures in adult patients with established cardiovascular disease (secondary prevention) and in high-risk adult patients without clinically evident coronary heart disease but with multiple risk factors (primary prevention), such as age, hypertension, low HDL-C, or a family history of early coronary heart disease. It is also used in pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia.
Dosage and direction
The dosage of Zocor must be individualized based on the patient’s baseline LDL-C level, the goal of therapy, and the patient’s response. The usual recommended starting dose is 10 or 20 mg once daily in the evening. Patients requiring large reductions in LDL-C (over 45%) may be started at 40 mg/day. The recommended dosage range is 5 to 40 mg daily. The 80 mg dose is reserved for patients who have been taking it chronically (e.g., 12 months or more) without evidence of myopathy and should not be started on new patients due to an increased risk of myopathy. The maximum recommended dose is 40 mg daily for new patients. Administration is oral, with or without food. Consistency in timing is advised. Dosage adjustments are necessary when co-administered with certain drugs that increase simvastatin exposure (see Drug Interactions). Renal impairment typically does not necessitate dosage adjustment. The dosage in pediatric patients (10-17 years) is 10 mg once daily in the evening, with a maximum recommended dose of 40 mg.
Precautions
Myopathy/Rhabdomyolysis: Simvastatin, like other statins, can cause myopathy (muscle pain, tenderness, or weakness with elevated creatine kinase [CK]) and, in rare cases, rhabdomyolysis with acute renal failure secondary to myoglobinuria. This risk is dose-related and increased by concomitant use of certain drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Hepatic Effects: Increases in serum transaminases have been reported. Liver enzyme tests should be performed before initiation of therapy, at 12 weeks following initiation or any dose elevation, and periodically thereafter. Therapy should be discontinued if persistent elevations occur. Renal Effects: Rhabdomyolysis can lead to acute renal failure. Endocrine Effects: Statins may affect biochemical markers of thyroid and adrenal function. Increases in HbA1c and fasting serum glucose levels have been reported. Cognitive Impairment: Rare post-marketing reports of cognitive impairment (e.g., memory loss, confusion) have been noted, which are generally non-serious and reversible upon discontinuation. Use in Specific Populations: Exercise caution in patients with a history of liver disease or heavy alcohol consumption. Use in elderly patients may warrant careful monitoring due to a higher likelihood of decreased renal function and concomitant medication use.
Contraindications
- Hypersensitivity to simvastatin or any component of the formulation.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing products).
- Concomitant use with cyclosporine, danazol, or gemfibrozil.
- Pregnancy and breastfeeding. Statins are contraindicated in pregnancy due to a risk of fetal harm and should be discontinued immediately upon pregnancy recognition. They should not be used by nursing mothers.
Possible side effect
The following adverse reactions have been associated with Zocor therapy, listed by system and approximate frequency: Gastrointestinal: Constipation (common), abdominal pain (common), flatulence (common), dyspepsia (common), nausea (common), pancreatitis (rare). Musculoskeletal: Myalgia (common), muscle cramps (common), arthralgia (common), myopathy (uncommon), rhabdomyolysis (rare). Elevated creatine kinase (common). Nervous System: Headache (very common), dizziness (common), insomnia (common), peripheral neuropathy (rare), memory impairment (rare). Hepatic: Elevated transaminases (common). Dermatological: Rash (common), pruritus (common). Other: Asthenia (common).
Drug interaction
Zocor is a substrate of CYP3A4. Concomitant use with drugs that inhibit this enzyme system can dramatically increase simvastatin plasma concentrations and the risk of myopathy. Contraindicated Combinations: Strong CYP3A4 inhibitors (see Contraindications), gemfibrozil, cyclosporine, danazol. Use with Caution and Dose Limitations:
- Other Fibrates (except gemfibrozil): e.g., fenofibrate. Increased risk of myopathy. Use the lowest necessary dose of simvastatin.
- Amiodarone, Amlodipine, Ranolazine: Do not exceed 20 mg simvastatin daily.
- Lomitapide: Do not exceed 20 mg simvastatin daily (or 40 mg if previously stable for >1 year).
- Verapamil, Diltiazem: Do not exceed 10 mg simvastatin daily.
- Moderate CYP3A4 Inhibitors (e.g., fluconazole): Consider lower starting dose.
- Warfarin: Simvastatin may potentiate the anticoagulant effect. Monitor INR closely upon initiation or adjustment of therapy.
- Digoxin: Concomitant use may slightly increase digoxin concentrations.
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day. If it is not remembered until the next day, the patient should skip the missed dose and resume the usual dosing schedule with the next planned dose. The dose should not be doubled to make up for a missed dose.
Overdose
There is no specific antidote for simvastatin overdose. In the event of an overdose, symptomatic and supportive measures should be instituted. The patient should be treated symptomatically, with supportive measures instituted as required. Due to extensive protein binding, hemodialysis is not expected to significantly enhance clearance. Liver function and CK levels should be monitored.
Storage
Store Zocor tablets at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the medication in its original container, tightly closed, and protect from light and moisture. Keep all medications out of the reach of children and pets. Properly discard any unused or expired medication.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The author and publisher are not responsible for any specific health or allergy needs that may require medical supervision and are not liable for any damages or negative consequences from any treatment, action, application, or preparation, to any person reading or following the information in this document.
Reviews
“Prescribed Zocor 20mg post-MI as part of my secondary prevention strategy. Follow-up lipid panel after 3 months showed a 42% reduction in LDL, bringing me well below my target goal. Tolerability has been excellent with no side effects to report. A cornerstone of my cardiac rehab.” – J.D., 62 “As a primary care physician, I have prescribed simvastatin for over two decades. Its efficacy in reducing LDL-C and cardiovascular events is well-documented in countless patients. While I am vigilant for potential interactions and monitor LFTs and symptoms of myopathy, it remains a first-line, cost-effective option for appropriate patients.” – Dr. Eleanor Vance, MD “Started on 10mg for genetically high cholesterol. Initially experienced mild muscle cramping which subsided after a few weeks. My most recent labs showed fantastic results – total cholesterol down by over 30%. Very pleased with the outcome.” – Marcus W., 48 “After trying another statin with intolerable side effects, my cardiologist switched me to a lower dose of Zocor. The transition was smooth, and I have been able to stay on it long-term with effective cholesterol control and no adverse effects. It has been a crucial part of managing my familial hypercholesterolemia.” – Sarah L., 51