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| Drug Name: | Simvastatin |
| Manufacturer: | Cobalt Laboratories Inc. |
| Other Info: | Women who are breastfeeding should not use simvastatin. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.Manufactured for :Cobalt Laboratories, Bonita Springs, Florida, USA. 34134By:Cobalt Pharmaceuticals Inc.Mississauga, Canada L5N 2B8Item Number: 102-661-02Date: July 2008 |
| Clinical Trials: | |
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.Simvastatin is contraindicated in the following conditions:Hypersensitivity to any component of this medication [see Adverse Reactions (6.2)].Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels [see Warnings and Precautions (5.2)].Women who are pregnant or may become pregnant.
Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development.
Because HMG-CoA reductase inhibitors (statins) decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, simvastatin may cause fetal harm when administered to a pregnant woman.
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.
There are no adequate and well-controlled studies of use with simvastatin during pregnancy; however, in rare reports congenital anomalies were observed following intrauterine exposure to statins.
In rat and rabbit animal reproduction studies, simvastatin revealed no evidence of teratogenicity.
Simvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive.
If the patient becomes pregnant while taking this drug, simvastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].Nursing mothers.
It is not known whether simvastatin is excreted into human milk; however, a small amount of another drug in this class does pass into breast milk.
Because statins have the potential for serious adverse reactions in nursing infants, women who require treatment with simvastatin should not breastfeed their infants [see Use in Specific Populations (8.3)].
NIH - Clinical Trials