Zetlow-10 Contraindications

Ezetimibe tablets are contraindicated in the following conditions: The combination of ezetimibe with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels.
Women who are pregnant or may become pregnant: Because statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, ezetimibe in combination with a statin 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 Pregnancy & Lactation.]
Nursing mothers: Because statins may pass into breast milk, and because statins have the potential to cause serious adverse reactions in nursing infants, women who require ezetimibe treatment in combination with a statin should be advised not to nurse their infants [see Use in Pregnancy & Lactation].
Patients with a known hypersensitivity to any component of this product: Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria have been reported with ezetimibe [see Adverse Reactions].