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FLUVASTATIN EXTENDED-RELEASE-ORAL (cont.)

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), diabetes (poorly controlled), alcohol use, any allergies (especially to other "statins"). The rare development of severe muscle damage (see Side Effects) can infrequently lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially muscle damage. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that women of child-bearing age use effective birth control measures to prevent pregnancy while taking this drug since fluvastatin may cause fetal harm. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also the How To Use section. Use caution if the following drugs are combined with fluvastatin because serious side effects such as muscle injury (myopathy) infrequently could occur: fibrates (e.g., gemfibrozil, fenofibrate), high-dose niacin (1 gram or more per day). Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain anti-diabetic medicine (sulfonylureas such as glyburide), "blood thinners" (e.g., warfarin), cholestyramine, colestipol, cyclosporine, phenytoin, rifamycins (e.g., rifampin). Do not start or stop any medicine without doctor or pharmacist approval.




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