"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
After oral administration of lovastatin immediate-release to mice the median lethal dose observed was > 15 g/m² .
Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage with lovastatin immediate-release have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 g to 6 g.
Until further experience is obtained, no specific treatment of overdosage with Altoprev® can be recommended.
The dialyzability of lovastatin and its metabolites in man is not known at present.
The use of Altoprev® is contraindicated in the following conditions:
- Concomitant administration of strong CYP3A inhibitors [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
- Concomitant administration of erythromycin [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS ]
- Hypersensitivity to any component of this product. [see ADVERSE REACTIONS].
- Active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see WARNINGS AND PRECAUTIONS].
- Women who are pregnant or may become pregnant. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Altoprev® may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy [see Use In Specific Populations and Nonclinical Toxicology].
- Nursing mothers. Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require Altoprev® treatment should be advised not to nurse their infants. [see Use in Specific Populations].
Last reviewed on RxList: 5/23/2014
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