--an enzyme blocker (HMG-CoA reductase inhibitor)
--a substrate of cytochrome P450 3A4 (CYP3A4)
--blocks the production of cholesterol in the body
--prescribed for adults, children down to 10 years of age and girls who have menstruated for at least a year
--used along with a proper diet to help lower cholesterol and fats (triglycerides) in the blood
--(rare) can cause the breakdown of skeletal muscle tissue leading to kidney failure, look for muscle pain or tenderness, muscle weakness, fever or flu symptoms, dark colored urine
--in 2006 zocor was the second best selling drug in the U.S.
--Zocor lost its patent protections in June 2006, so generics are available
--Lipitor, Zocor, Crestor, and other drugs in the "statin" class have been judged by many experts to be "pretty much interchangeable"
--can cause birth defects in an unborn baby
--DO NOT USE if you are pregnant, breast feeding, or have liver disease
--BEWARE if you have diabetes, underactive thyroid, kidney disease, muscle or blood disorder --Zocor 5 mg - shield-shaped, buff, film-coated tablets
--Zocor 10 mg - shield-shaped, peach-colored, film-coated tablets
--Zocor 20 mg - shield-shaped, tan, film-coated tablets
--Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet
--USU prescribed after non-drug treatment options have not been successful at lowering cholesterol (e.g., diet change, increase in exercise, weight loss if overweight)
--familial hypercholesterolemia may require more frequent dosing
--AVOID eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise
--costs $4/pill or $2/pill for generic
--one statin isn't any better than any other (except, perhaps, some are more dangerous)
--statins are "one of the most unnecessary drugs in medicine" (Mercola)
--There are a small group of people with genetic enzyme defects that have cholesterols levels above 325-350. These are about the only individuals in my experience, who seem to benefit from statins. In my practice of 10,000 patients there has been a grand total of three patients that required statins to control this genetic problem.
--pretty much every other person can normalize their cholesterol levels with diet & exercise
--physicians are prescribing these drugs for anyone with a heart attack, even if their cholesterol level is already dangerously low (below 150).
--nearly all conventional physicians fail to appreciate is that there is a danger of having a cholesterol that is too low.
--Mercola's plan (what to do instead of taking statins):
1) normalize your insulin levels by eliminating sugar and grains from your diet
2) take a high-quality fish oil that is chock full of beneficial omega-3 fatty acids
3) check your iron levels as elevated levels of iron can cause major oxidative damage in the blood vessels, heart and other organs
4) get regular exercise
while ON ZOCOR
--takes up to 4 weeks before drug takes effect
--"continue taking this medication even if you feel well", use regularly, pay out the nose
--Avoid foods that are high in fat or cholesterol
--zocor interacts with many drugs so don't forget to confess your prescriptions, all herbs, vitamins, minerals, supplements or recreational drugs that you are taking
--DO NOT USE if you are allergic to simvastatin
--It is not known whether Zocor passes into breast milk. Do not take Zocor without telling your doctor if you are breast-feeding a baby. Zocor is not for use in children younger than 10 years of age.
--to be taken with a full glass of water, usually at bedtime or with an evening meal
--if you take Zocor several times daily, take it with meals
--blood tests esp liver tests need to be conducted regularly
--"Zocor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely."
--"You may need to take Zocor on a long-term basis for the treatment of high cholesterol."
--Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
--AVOID Grapefruit and grapefruit juice (may interact and lead to dangerous effects)
--don't worry about it, just tolerate these side effects according to the lit: mild stomach pain, gas, bloating, stomach upset, heartburn, nausea, constipation, diarrhea.
--CALL 911 IF YOU HAVE an anaphylactic allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat
--stop taking the pills and call your doc if you have muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine
--like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten X the ULN
--ULN = upper limit of normal
--Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.
--risk is dose related, incidence in one study ranged from .02-.53%
--Simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected. In most cases, muscle symptoms and CK increases resolved when treatment was promptly discontinued.
--Many of the patients who have develope rhabdomyolysis with 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 simvastatin should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
A PARTIAL LIST OF things THAT INTERACT WITH ZOCOR:
--If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take simvastatin at least 1 hour before or at least 2 hours after
--gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);
--niacin (Nicolar, Nicobid, Slo-Niacin, others);
--cholestyramine (Questran) or colestipol (Colestid);
--a blood thinner such as warfarin (Coumadin); or
--amiodarone (Cordarone), diltiazem (Cartia, Cardizem, Dilacor, Tiazac), or verapamil (Verelan, Calan, Isoptin);
--erythromycin (E-Mycin, Ery-Tab, others), clarithromycin (Biaxin), or telithromycin (Ketek);
--antifungals: itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral);
--drugs that weaken your immune system (cancer meds, steroids), cyclosporine (Neoral, Sandimmune, Gengraf), sirolimus (Rapamune), tacrolimus (Prograf), and others;
--HIV or AIDS medication such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), lopinavir-ritonavir (Kaletra), or saquinavir (Invirase, Fortovase).
--The risk of myopathy/rhabdomyolysis is increased by concomitant use of simvastatin with:
Potent inhibitors of CYP3A4: Simvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of cytochrome P450 3A4 (CYP3A4). When simvastatin is used with a potent inhibitor of CYP3A4, elevated plasma levels of HMG-CoA reductase inhibitory activity can increase the risk of myopathy and rhabdomyolysis, particularly with higher doses of simvastatin.
--The use of simvastatin concomitantly with the potent CYP3A4 inhibitors itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (> 1 quart daily) should be avoided. Concomitant use of other medicines labeled as having a potent inhibitory effect on CYP3A4 should be avoided. If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with simvastatin should be suspended during the course of treatment.
--Gemfibrozil, particularly with higher doses of simvastatin: The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with gemfibrozil. The combined use of simvastatin with gemfibrozil should be avoided
--Other lipid-lowering drugs (other fibrates or ≥ 1 g/day of niacin): Caution should be used when prescribing other fibrates or lipid-lowering doses (≥ 1 g/day) of niacin with simvastatin, as these agents can cause myopathy when given alone. The benefit of further alterations in lipid levels by the combined use of simvastatin with other fibrates or niacin should be carefully weighed against the potential risks of these combinations.
--Cyclosporine or danazol, with higher doses of simvastatin: The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporine or danazol. The benefits of the use of simvastatin in patients receiving cyclosporine or danazol should be carefully weighed against the risks of these combinations.
--Amiodarone or verapamil, with higher doses of simvastatin: The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with amiodarone or verapamil. The combined use of 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. In an ongoing clinical trial, myopathy has been reported in 6% of patients receiving 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%).
***This list is not complete and there may be other drugs that can interact with Zocor
FDA Issues Early Communication about an Ongoing Review of Vytorin
--based on preliminary results from a recently completed study – the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE)
--Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.
--FDA says it will review Merck and Schering Plough’s recent trial once the FDA receives the final study results
--Merck/Schering Plough stated that the study demonstrated no significant differences between the combination product and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries. The study was not designed to detect any difference in risk of having a heart attack or stroke between the two treatments.
--An ongoing trial called -- Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT) -- is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke.
--Full text at: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm.