"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
No specific recommendations concerning the treatment of an overdosage can be made. Should an overdose occur, it should be treated symptomatically and supportive measures should be undertaken as required.
Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS). Concurrent treatment with gemfibrozil due to a risk for rhabdomyolysis (see WARNINGS: Skeletal Muscle).
Pregnancy and lactation: 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. Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Cerivastatin sodium should be administered to women of child-bearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, cerivastatin sodium should be discontinued and the patient should be apprised of the potential hazard to the fetus. Hypersensitivity to any component of this medication.
Last reviewed on RxList: 4/17/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Baycol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.