Drugs & Vitamins

Baycol - Withdrawn From The Market Active Ingredients: Cerivastatin - Withdrawn From The Market Representative Names: Baycol - Withdrawn From The Market What are cerivastatin tablets? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with cerivastatin? What side effects may I notice from taking cerivastatin? What should I watch for while taking cerivastatin? Where can I keep my medicine? What are cerivastatin tablets? (Back to top) CERIVASTATIN (Baycol™) blocks the body's ability to make cholesterol. Cerivastatin can help lower blood cholesterol for patients who are at risk of getting heart disease or a stroke. It is only for patients whose cholesterol level is not controlled by diet. It is not a cure. NOTE: This drug is discontinued in the United States. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •an alcohol problem •any hormone disorder (such as diabetes, under-active thyroid) •blood salt imbalance •infection •kidney disease •liver disease •low blood pressure •muscle disorder or condition •recent surgery •seizures (convulsions) •severe injury •an unusual or allergic reaction to cerivastatin, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I take this medicine? (Back to top) Take cerivastatin tablets by mouth. Follow the directions on the prescription label. Swallow the cerivastatin with a drink of water. Cerivastatin should be taken at in the evening with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. What drug(s) may interact with cerivastatin? (Back to top) •alchohol-containing beverages •amiodarone •bosentan •certain antibiotics such as clarithromycin and erythromycin •cimetidine •diltiazem •grapefruit juice •medicines for fungal infections (examples: fluconazole, itraconazole, ketoconazole, miconazole, voriconazole) •herbal medicines such as red yeast rice •medicines for treating HIV infections •medicines that suppress your immune response (cyclosporine) •medicines to lower cholesterol or triglycerides (examples: cholestyramine, clofibrate, colestipol, fenofibrate, gemfibrozil, niacin) •medicine used to stop early pregnancy (mifepristone, RU-486 or Mifeprex™) •montelukast •nefazodone •niacin •phenytoin •spironolactone •verapamil Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking cerivastatin? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: Rare or uncommon: •dark yellow or brown urine •decreased urination, difficulty passing urine •fever •muscle pain, tenderness, cramps, or weakness •redness, blistering, peeling or loosening of the skin, including inside the mouth •skin rash, itching •unusual tiredness or weakness •yellowing of the skin or eyes Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •diarrhea •difficulty sleepine •gas •headache •joint pain •nausea, vomiting •stomach upset or pain •tiredness What should I watch for while taking cerivastatin? (Back to top) Visit your prescriber or health care professional for regular checks on your progress. You will need to have regular tests to make sure your liver is working properly. Tell your prescriber or health care professional as soon as you can if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness. Cerivastatin is only part of a total cholesterol-lowering program. Your physician or dietician can suggest a low-cholesterol and low-fat diet that will reduce your risk of getting heart and blood vessel disease. Avoid alcohol and smoking, and keep a proper exercise schedule. If you are going to have surgery tell your prescriber or health care professional that you are taking cerivastatin. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at controlled room temperature between 20 to 25 degrees C (68 to 77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date. Last Updated:08/14/2006 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.