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Generic Names: Simvastatin , Generic Zocor
Brand names: Zocor
Zocor 40mg
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Zocor Information

Brand Name: Zocor

Generic Name: Simvastatin, Simbastatine

Other Common Names: Simvastatina

Zocor (simvastatin) is a lipid lowering drug. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol. In patients with CHD or at high risk of CHD, Zocor can be started simultaneously with diet.

Reductions in Risk of CHD Mortality and Cardiovascular Events

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, Zocor is indicated to:

Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles

Zocor is indicated to:

Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)

Zocor is indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolemia, if after an adequate trial of diet therapy the following findings are present:

  1. LDL cholesterol remains <190 mg/dL; or
  2. LDL cholesterol remains <160 mg/dL and

Since the goal of Zocor treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor Zocor therapy.

Zocor is indicated to reduce elevated LDL-C and TG levels in patients with Type IIb hyperlipidemia (where hypercholesterolemia is the major abnormality). However, Zocor has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

Zocor Ingredients and Composition

Zocor (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion simvastation, the active ingredient in Zocor, which is an inactive lactone, is hydrolyzed to the corresponding b-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.

Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1a,3a,7b,8b(2S*,4S*),-8ab]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57.

Simvastatin, the active ingredient in Zocor, is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.

Zocor tablets for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients:

Butylated hydroxyanisole is added as a preservative.

Pharma-Help does not have information on the 'other ingredients' in Zocor.

How Does Zocor Work?

The involvement of low-density lipoprotein cholesterol (LDL-C) in atherogenesis has been well-documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological studies have established that elevated plasma levels of total cholesterol (total-C), LDL-C, and apolipoprotein B (Apo B) promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of high-density lipoprotein cholesterol (HDL-C) and its transport complex, Apo A-I, are associated with decreased cardiovascular risk. High plasma triglycerides (TG) and cholesterol-enriched TG-rich lipoproteins, including very-low-density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis. Elevated plasma TG are frequently found in a triad with low HDL-C and small LDL particles, as well as in association with non-lipid metabolic risk factors for CHD. As such, total plasma TG has not consistently been shown to be an independent risk factor for CHD. Furthermore, the independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

In the Scandinavian Simvastatin Survival Study (4S), the effect of improving lipoprotein levels with Zocor on total mortality was assessed in 4,444 patients with CHD and baseline total cholesterol (total-C) 212-309 mg/dL (5.5-8.0 mmol/L). The patients were followed for a median of 5.4 years. In this multicenter, randomized, double-blind, placebo-controlled study, Zocor significantly reduced the risk of mortality by 30% (11.5% vs 8.2%, placebo vs Zocor); of CHD mortality by 42% (8.5% vs 5.0%); and of having a hospital-verified non-fatal myocardial infarction by 37% (19.6% vs 12.9%). Furthermore, Zocor significantly reduced the risk for undergoing myocardial revascularization procedures (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty) by 37% (17.2% vs 11.4%).

Zocor has been shown to reduce both normal and elevated LDL-C concentrations. LDL is formed from very-low-density lipoprotein (VLDL) and is catabolized predominantly by the high-affinity LDL receptor. The mechanism of the LDL-lowering effect of Zocor may involve both reduction of VLDL cholesterol concentration, and induction of the LDL receptor, leading to reduced production and/or increased catabolism of LDL-C. Apo B also falls substantially during treatment with Zocor. As each LDL particle contains one molecule of Apo B, and since in patients with predominant elevations in LDL-C (without accompanying elevation in VLDL) little Apo B is found in other lipoproteins, this strongly suggests that Zocor does not merely cause cholesterol to be lost from LDL, but also reduces the concentration of circulating LDL particles. In addition, Zocor reduces VLDL and TG and increases HDL-C. The effects of Zocor on Lp(a), fibrinogen, and certain other independent biochemical risk markers for CHD are unknown.

Zocor is a specific inhibitor of HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate. The conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol.

How To Take Zocor and Zocor Dosage and Administration

Before starting their Zocor dosage, patients should be placed on a standard cholesterol-lowering diet. In patients with CHD or at high risk of CHD, Zocor can be started simultaneously with diet. The dosage should be individualized according to the goals of therapy and the patient's response. The Zocor dosage range is 5-80 mg/day (see below).

The recommended usual starting Zocor dose is 20 to 40 mg once a day in the evening. For patients at high risk for a CHD event due to existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter. See below for Zocor dosage recommendations in special populations (i.e., homozygous familial hypercholesterolemia, adolescents and renal insufficiency) or for patients receiving concomitant therapy (i.e., cyclosporine, amiodarone, verapamil, fibrates or niacin).

Patients with Homozygous Familial Hypercholesterolemia

The recommended Zocor dosage for patients with homozygous familial hypercholesterolemia is 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg. Zocor should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Adolescents (10-17 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended usual starting Zocor dose is 10 mg once a day in the evening. The recommended dosing range is 10-40 mg/day; the maximum recommended Zocor dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

Concomitant Lipid-Lowering Therapy

Zocor is effective alone or when used concomitantly with bile-acid sequestrants. If Zocor is used in combination with gemfibrozil, other fibrates or lipid-lowering doses (<1 g/day) of niacin, the dose of Zocor should not exceed 10 mg/day.

Patients taking Cyclosporine

In patients taking cyclosporine concomitantly with Zocor, therapy should begin with 5 mg/day and should not exceed 10 mg/day.

Patients taking Amiodarone or Verapamil

In patients taking amiodarone or verapamil concomitantly with Zocor, the dose should not exceed 20 mg/day.

Patients with Renal Insufficiency

Because Zocor does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal insufficiency. However, caution should be exercised when Zocor is administered to patients with severe renal insufficiency; such patients should be started at 5 mg/day and be closely monitored

If you suspect a Zocor Overdose

Significant lethality was observed in mice after a single oral Zocor dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with Zocor doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools.

A few cases of overdosage with Zocor have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 450 mg. Until further experience is obtained, no specific treatment of overdosage with Zocor can be recommended.

The dialyzability of simvastatin and its metabolites in man is not known at present.

Zocor Side Effects

The following Zocor side effects have been recorded:

Side effects occurring in adults at an incidence of 1% or greater in patients treated with Zocor, regardless of causality, in controlled clinical studies are shown below:

Body as a Whole

Gastrointestinal

Nervous System/Psychiatric

Respiratory Upper respiratory

Zocor Warnings

Myopathy/Rhabdomyolysis

Zocor (simvastatin), like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10X the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.

Potent inhibitors of CYP3A4: Cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily), particularly with higher doses of Zocor (simvastatin).

Lipid-lowering drugs that can cause myopathy when given alone: Gemfibrozil, other fibrates, or lipid-lowering doses (<1 g/day) of niacin, particularly with higher doses of Zocor (simvastatin).

Other drugs: Amiodarone or verapamil with higher doses of Zocor (simvastatin). In an ongoing clinical trial, myopathy has been reported in 6% of patients receiving Zocor (simvastatin) 80 mg and amiodarone. In an analysis of clinical trials involving 25,248 patients treated with simvastatin 20 to 80 mg, the incidence of myopathy was higher in patients receiving verapamil and simvastatin (4/635; 0.63%) than in patients taking simvastatin without a calcium channel blocker (13/21,224; 0.061%).

Consequently:

  1. Use of Zocor (simvastatin) concomitantly with itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided. If treatment with itraconazole, ketoconazole, erythromycin, or clarithromycin is unavoidable, therapy with simvastatin should be suspended during the course of treatment. Concomitant use with other medicines labeled as having a potent inhibitory effect on CYP3A4 at therapeutic doses should be avoided unless the benefits of combined therapy outweigh the increased risk.
  2. The dose of Zocor (simvastatin) should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporine, gemfibrozil, other fibrates or lipid-lowering doses (<1 g/day) of niacin. The combined use of Zocor (simvastatin) with fibrates or niacin should be avoided unless the benefit of further alteration in lipid levels is likely to outweigh the increased risk of this drug combination. Addition of these drugs to Zocor (simvastatin) typically provides little additional reduction in LDL-C, but further reductions of TG and further increases in HDL-C may be obtained.
  3. The dose of Zocor (simvastatin) should not exceed 20 mg daily in patients receiving concomitant medication with amiodarone or verapamil. The combined use of Zocor (simvastatin) at doses higher than 20 mg daily with amiodarone or verapamil should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy.
  4. All patients starting therapy with Zocor (simvastatin), or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. Zocor (simvastatin) therapy should be discontinued immediately if myopathy is diagnosed or suspected. The presence of these symptoms, and/or a CK level >10 times the ULN indicates myopathy. In most cases, when patients were promptly discontinued from treatment, muscle symptoms and CK increases resolved. Periodic CK determinations may be considered in patients starting therapy with Zocor (simvastatin) or whose dose is being increased, but there is no assurance that such monitoring will prevent myopathy.
  5. Many of the patients who have developed rhabdomyolysis on therapy with Zocor (simvastatin) have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients merit closer monitoring. Therapy with Zocor (simvastatin) should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.

Liver Dysfunction

Persistent increases (to more than 3X the ULN) in serum transaminases have occurred in approximately 1% of patients who received simvastatin in clinical studies. When Zocor (simvastatin) treatment was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels. The increases were not associated with jaundice or other clinical signs or symptoms. There was no evidence of hypersensitivity.

In 4S, the number of patients with more than one transaminase elevation to > 3X ULN, over the course of the study, was not significantly different between the Zocor (simvastatin) and placebo groups (14 [0.7%] vs. 12 [0.6%]). Elevated transaminases resulted in the discontinuation of 8 patients from therapy in the Zocor (simvastatin) group (n=2,221) and 5 in the placebo group (n=2,223). Of the 1,986 simvastatin treated patients in 4S with normal liver function tests (LFTs) at baseline, only 8 (0.4%) developed consecutive LFT elevations to > 3X ULN and/or were discontinued due to transaminase elevations during the 5.4 years (median follow-up) of the study. Among these 8 patients, 5 initially developed these abnormalities within the first year. All of the patients in this study received a starting dose of 20 mg of Zocor (simvastatin); 37% were titrated to 40 mg.

In 2 controlled clinical studies in 1,105 patients, the 12-month incidence of persistent hepatic transaminase elevation without regard to drug relationship was 0.9% and 2.1% at the 40- and 80-mg dose, respectively. No patients developed persistent liver function abnormalities following the initial 6 months of treatment at a given Zocor dose.

It is recommended that liver function tests be performed before the initiation of treatment, and thereafter when clinically indicated. Patients titrated to the 80-mg Zocor dose should receive an additional test prior to titration, 3 months after titration to the 80-mg dose, and periodically thereafter (e.g., semiannually) for the first year of treatment. Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return to normal. Should an increase in AST or ALT of 3X ULN or greater persist, withdrawal of therapy with Zocor is recommended.

The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver diseases or unexplained transaminase elevations are contraindications to the use of Zocor (simvastatin).

As with other lipid-lowering agents, moderate (less than 3X ULN) elevations of serum transaminases have been reported following therapy with Zocor (simvastatin). These changes appeared soon after initiation of therapy with simvastatin, were often transient, were not accompanied by any symptoms and did not require interruption of treatment.

Zocor Precautions and Contraindications

General

Zocor (simvastatin) may cause elevation of CK and transaminase levels This should be considered in the differential diagnosis of chest pain in a patient on therapy with Zocor.

Zocor Contraindications

Active liver disease or unexplained persistent elevations of serum transaminases are contraindicated with Zocor. Pregnancy and lactation are contraindicated with Zocor. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase such as Zocor to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, Zocor is contraindicated during pregnancy and in nursing mothers. Zocor should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, Zocor should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus.

Taking Zocor during Pregnancy or Breast-feeding

Because of the ability of inhibitors of HMG-CoA reductase such as Zocor to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, Zocor is contraindicated during pregnancy and in nursing mothers. Zocor should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, Zocor should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus.

Zocor and Alcohol Interaction

The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver diseases or unexplained transaminase elevations are contraindications to the use of Zocor (simvastatin).

Zocor Clinical Trials and Studies

Clinical Zocor Studies in Adults

Reductions in Risk of CHD Mortality and Cardiovascular Events

In 4S, the effect of therapy with Zocor on total mortality was assessed in 4,444 patients with CHD and baseline total cholesterol 212-309 mg/dL (5.5-8.0 mmol/L). In this multicenter, randomized, double-blind, placebo-controlled study, patients were treated with standard care, including diet, and either Zocor 20-40 mg/day (n=2,221) or placebo (n=2,223) for a median duration of 5.4 years. After six weeks of treatment with Zocor the median (25th and 75th percentile) changes in LDL-C, TG, and HDL-C were -39% (-46, -31%), -19% (-31, 0%), and 6% (-3, 17%). Over the course of the study, treatment with Zocor led to mean reductions in total-C, LDL-C and TG of 25%, 35%, and 10%, respectively, and a mean increase in HDL-C of 8%. Zocor significantly reduced the risk of mortality by 30%, (p=0.0003, 182 deaths in the Zocor group vs 256 deaths in the placebo group). The risk of CHD mortality was significantly reduced by 42%, (p=0.00001, 111 vs 189 deaths). There was no statistically significant difference between groups in non-cardiovascular mortality. Zocor also significantly decreased the risk of having major coronary events (CHD mortality plus hospital-verified and silent non-fatal myocardial infarction [MI]) by 34%, (p<0.00001, 431 vs 622 patients with one or more events). The risk of having a hospital-verified non-fatal MI was reduced by 37%. Zocor significantly reduced the risk for undergoing myocardial revascularization procedures (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty) by 37%, (p<0.00001, 252 vs 383 patients). Furthermore, Zocor significantly reduced the risk of fatal plus non-fatal cerebrovascular events (combined stroke and transient ischemic attacks) by 28% (p=0.033, 75 vs 102 patients). Zocor reduced the risk of major coronary events to a similar extent across the range of baseline total and LDL cholesterol levels. Because there were only 53 female deaths, the effect of Zocor on mortality in women could not be adequately assessed. However, Zocor significantly lessened the risk of having major coronary events by 34% (60 vs 91 women with one or more event). The randomization was stratified by angina alone (21% of each treatment group) or a previous MI. Because there were only 57 deaths among the patients with angina alone at baseline, the effect of Zocor on mortality in this subgroup could not be adequately assessed. However, trends in reduced coronary mortality, major coronary events and revascularization procedures were consistent between this group and the total study cohort. Additionally, in this study, 1,021 of the patients were 65 and older. Cholesterol reduction with simvastatin resulted in similar decreases in relative risk for total mortality, CHD mortality, and major coronary events in these elderly patients, compared with younger patients.

The Heart Protection Study (HPS) was a large, multi-center, placebo-controlled, double-blind study with a mean duration of 5 years conducted in 20,536 patients (10,269 on Zocor 40 mg and 10,267 on placebo). Patients were allocated to treatment using a covariate adaptive method3 which took into account the distribution of 10 important baseline characteristics of patients already enrolled and minimized the imbalance of those characteristics across the groups. Patients had a mean age of 64 years (range 40-80 years), were 97% Caucasian and were at high risk of developing a major coronary event because of existing coronary heart disease (65%), diabetes (Type 2, 26%; Type 1, 3%), history of stroke or other cerebrovascular disease (16%), peripheral vessel disease (33%), or hypertension in males 65 years of age and older (6%). At baseline, 3,421 patients (17%) had LDL-C levels below 100 mg/dL, of whom 953 (9%) had LDL-C levels below 80 mg/dL; 7,068 patients (34%) had levels between 100 and 130 mg/dL; and 10,047 patients (49%) had levels greater than 130 mg/dL.

The HPS results showed that Zocor 40 mg/day significantly reduced: total and CHD mortality; nonfatal myocardial infarctions, stroke, and revascularization procedures (coronary and non-coronary).

Two composite endpoints were defined in order to have sufficient events to assess relative risk reductions across a range of baseline characteristics. A composite of major coronary events (MCE) was comprised of CHD mortality and non-fatal MI (analyzed by time-to-first event; 898 patients treated with Zocor had events and 1,212 patients on placebo had events). A composite of major vascular events (MVE) was comprised of MCE, stroke and revascularization procedures including coronary, peripheral and other non-coronary procedures (analyzed by time-to-first event; 2,033 patients treated with Zocor had events and 2,585 patients on placebo had events). Significant relative risk reductions were observed for both composite endpoints (27% for MCE and 24% for MVE, p<0.0001). Furthermore, treatment with Zocor produced significant relative risk reductions for all components of the composite endpoints. The risk reductions produced by Zocor in both MCE and MVE were evident and consistent regardless of cardiovascular disease related medical history at study entry (i.e., CHD alone; or peripheral vascular disease, cerebrovascular disease, diabetes or treated hypertension, with or without CHD), gender, age, creatinine levels up to the entry limit of 2.3 mg/dL, baseline levels of LDL-C, HDL-C, apolipoprotein B and A-1, baseline concomitant cardiovascular medications (i.e., aspirin, beta blockers, or calcium channel blockers), smoking status, alcohol intake, or obesity. Diabetics showed risk reductions for MCE and MVE due to Zocor treatment regardless of baseline HbA1c levels or obesity with the greatest effects seen for diabetics without CHD.

Angiographic Studies

In the Multicenter Anti-Atheroma Study, the effect of simvastatin, the active ingredient in Zocor, on atherosclerosis was assessed by quantitative coronary angiography in hypercholesterolemic patients with coronary heart disease. In this randomized, double-blind, controlled study, patients were treated with Zocor (simvastatin) 20 mg/day or placebo. Angiograms were evaluated at baseline, two and four years. The co-primary study endpoints were mean change per-patient in minimum and mean lumen diameters, indicating focal and diffuse disease, respectively. Zocor (simvastatin) significantly slowed the progression of lesions as measured in the Year 4 angiogram by both parameters, as well as by change in percent diameter stenosis. In addition, simvastatin significantly decreased the proportion of patients with new lesions and with new total occlusions.

Homozygous Familial Hypercholesterolemia

In a controlled clinical study, 12 patients 15-39 years of age with homozygous familial hypercholesterolemia received Zocor 40 mg/day in a single dose or in 3 divided doses, or 80 mg/day in 3 divided doses. Eleven of the 12 patients had reductions in LDL-C. In those patients with reductions, the mean LDL-C changes for the 40- and 80-mg doses were 14% (range 8% to 23%, median 12%) and 30% (range 14% to 46%, median 29%), respectively. One patient had an increase of 15% in LDL-C. Another patient with absent LDL-C receptor function had an LDL-C reduction of 41% with the 80-mg dose.

Endocrine Function

In clinical studies, Zocor (simvastatin) did not impair adrenal reserve or significantly reduce basal plasma cortisol concentration. Small reductions from baseline in basal plasma testosterone in men were observed in clinical studies with Zocor (simvastatin), an effect also observed with other inhibitors of HMG-CoA reductase and the bile acid sequestrant cholestyramine. There was no effect on plasma gonadotropin levels. In a placebo-controlled 12-week study there was no significant effect of Zocor 80 mg on the plasma testosterone response to human chorionic gonadotropin (hCG). In another 24-week study, Zocor 20-40 mg had no detectable effect on spermatogenesis. In 4S, in which 4,444 patients were randomized to Zocor 20-40 mg/day or placebo for a median duration of 5.4 years, the incidence of male sexual adverse events in the two treatment groups was not significantly different. Because of these factors, the small changes in plasma testosterone are unlikely to be clinically significant. The effects, if any, on the pituitary-gonadal axis in pre-menopausal women are unknown.

Clinical Studies in Adolescents

In a double-blind, placebo-controlled study, 175 patients (99 adolescent boys and 76 post-menarchal girls) 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (heFH) were randomized to Zocor (simvastatin) (n=106) or placebo (n=67) for 24 weeks (base study). Inclusion in the study required a baseline LDL-C level between 160 and 400 mg/dL and at least one parent with an LDL-C level >189 mg/dL. The dosage of Zocor (simvastatin) (once daily in the evening) was 10 mg for the first 8 weeks, 20 mg for the second 8 weeks, and 40 mg thereafter. In a 24-week extension, 144 patients elected to continue therapy and received simvastatin 40 mg or placebo.

Zocor significantly decreased plasma levels of total-C, LDL-C, and Apo B. Results from the extension at 48 weeks were comparable to those observed in the base study.

After 24 weeks of treatment, the mean achieved LDL-C value was 124.9 mg/dL (range: 64.0-289.0 mg/dL) in the Zocor 40 mg group compared to 207.8 mg/dL (range: 128.0-334.0 mg/dL) in the placebo group.

The safety and efficacy of doses above Zocor 40 mg daily have not been studied in children with heterozygous familial hypercholesterolemia. The long-term efficacy of simvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established

Storing Zocor

Store Zocor between 5-30°C (41-86°F).

Additional Patient Information for Zocor

Patients should be advised about substances they should not take concomitantly with Zocor (simvastatin) and be advised to report promptly unexplained muscle pain, tenderness, or weakness. Patients should also be advised to inform other physicians prescribing a new medication that they are taking Zocor.

Information about the Manufacturer of Zocor

Tablets Zocor (simvastatin) 5 mg, 10 mg, 20 mg, 40 mg and 80 mg are manufactured by:

MERCK SHARP & DOHME LTD, Cramlington, Northumberland, UK NE23 3JU

Articles and information related to Zocor

Credits for Zocor Information

Zocor information on this page is copyright by Drug Information at Pharma-Help.com, reprinted with Permission. All Rights Reserved. Other pages with reprint permission include Zocor. Additional encyclopaedic information: Zocor.

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