Drug Information For: SIMVASTATIN 5MG TABLETS
Ingredient Name: SIMVASTATIN (SIM-va-stat-in)
Drug Manufacturer: AUROBINDO
Common Uses: This medicine is an HMG-CoA reductase inhibitor or "statin" used in combination with a low-cholesterol and low-fat diet to lower cholesterol (LDL) and triglyceride levels and to raise good cholesterol (HDL) levels in your blood. It may also be used in certain adolescent patients, age 10 to 17 years, who have a genetically caused cholesterol problem. This medicine is not a cure for high cholesterol, but may help to control it. This medicine may also be used in certain patients to reduce the risk of blood vessel blockage, heart attack, stroke, and death due to heart disease. It may also be used to treat other conditions as determined by your doctor.
Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking cyclosporine, danazol, gemfibrozil, a hepatitis C virus (HCV) protease inhibitor (eg, boceprevir, telaprevir), an HIV protease inhibitor (eg, ritonavir, lopinavir, nelfinavir), itraconazole, ketoconazole, certain macrolide antibiotics (eg, erythromycin, clarithromycin), mibefradil, nefazodone, posaconazole, or telithromycin. DO NOT TAKE THIS MEDICINE if you take conivaptan or have taken it within the past 7 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking amiodarone, amlodipine, anticoagulants (eg, warfarin), azole antifungals (eg, fluconazole, voriconazole), bosentan, carbamazepine, colchicine, daptomycin, delavirdine, digoxin, diltiazem, dronedarone, efavirenz, fibrates (eg, clofibrate, fenofibrate), fusidic acid, imatinib, macrolide antibiotics (eg, troleandomycin), macrolide immunosuppressants (eg, tacrolimus), niacin, ranolazine, rifamycins (eg, rifampin), risperidone, St. John's wort, streptogramins (eg, dalfopristin, quinupristin), or verapamil. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including low blood pressure; kidney problems; muscle problems or a family history of muscle problems; diabetes; low thyroid function; serious metabolism, hormonal or electrolyte problems; a serious infection; allergies (especially to other "statins"); pregnancy or if you are able to become pregnant; or breast-feeding. Tell your doctor if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse. Tell your doctor if you have had an organ transplant and are taking medicine to suppress a rejection reaction, or if you are scheduled for major surgery, or have recently had major surgery or a serious injury. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have liver problems or unexplained abnormal liver function test results. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant, may become pregnant, or are breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. Take this medicine in the evening unless otherwise directed by your doctor. EATING GRAPEFRUIT OR DRINKING GRAPEFRUIT JUICE may increase the amount of this medicine in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than one quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking this medicine. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly-closed container, away from heat and light. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TAKING THIS MEDICINE even if you feel well. Most people with high cholesterol do not feel sick. Do not miss any doses. Taking this medicine at the same time each day will help you to remember. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. IT MAY TAKE SEVERAL WEEKS for this medicine to work. DO NOT STOP USING THIS MEDICINE without first checking with your doctor. Your dosage is based on your medical condition, response to therapy, and the other medicines that you are taking. DO NOT EXCEED the recommended dose of this medicine without checking with your doctor. Laboratory and/or medical tests may be done at the start of therapy and while you are taking this medicine to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may need to be stopped for a few days before certain types of surgery. THIS MEDICINE MAY INCREASE YOUR RISK FOR LIVER PROBLEMS. Rarely, severe and sometimes fatal liver failure has been reported in patients taking this medicine. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with this medicine, or if you have a history of liver problems. Before drinking alcohol, talk with your doctor about the safe use of this medicine and alcohol. MUSCLE PROBLEMS (MYOPATHY) MAY OCCUR with this medicine. The risk of muscle problems may be greater in people who take higher doses of this medicine, in people older than 64 years of age, in females, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking this medicine. RARELY, CHANGES TO THE SKIN, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine, especially muscle problems. FOR WOMEN: WOMEN WHO ARE ABLE TO BECOME PREGNANT should use effective birth control while taking this medicine. Check with your doctor if you have questions about the use of effective birth control. DO NOT USE THIS MEDICINE if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include constipation, headache, mild stomach pain, or nausea. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience burning, numbness, or tingling; change in the amount of urine produced; confusion; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain; loss of appetite; memory problems; muscle aches, pain, tenderness, or weakness, especially if associated with unusual tiredness and a fever; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea, or stomach or back pain; shortness of breath; trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; or yellowing of skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information: FOR BEST RESULTS, this medicine should be used along with exercise, a low-cholesterol/low-fat diet, and a weight loss program if you are overweight. FOLLOW THE DIETARY PLAN provided by your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2012 Wolters Kluwer Health, Inc.
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