Lovastatin contraindications

Lovastatin
ALTOPREV® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Lovastatin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Contraindications

The use of Altoprev® is contraindicated in the following conditions:

• Concomitant administration of strong CYP3A inhibitors [see Warnings and Precautions, Skeletal Muscle Effects (5.1) and Drug Interactions (7.1)].
• Concomitant administration of erythromycin [see Warnings and Precautions, Skeletal Muscle Effects (5.1) and Drug Interactions (7.1)].
• Hypersensitivity to any component of this product [see Adverse Reactions (6.1)]. Active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions, Liver Enzyme Abnormalities (5.2)].
• 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 (8.1) and Nonclinical Toxicology (13.1)].
• 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 (8.3)].