It is recommended that liver enzymes be checked before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. CRESTOR is a trademark of the AstraZeneca group of companies © AstraZeneca 2003, 2005, 2007 Licensed from SHIONOGI & CO., LTD., Osaka, Japan Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 By: IPR Pharmaceuticals, Inc.Carolina, PR 00984 ASTRAZENECA REV 11/07 32834–00 630400
CRESTOR is contraindicated in the following conditions: Patients with a known hypersensitivity to any components of this product.
Hypersensitivity reactions including rash pruritus, urticaria and angioedema have been reported with CRESTOR.
[see Adverse Reactions (6.1)]. Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (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, CRESTOR 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 (13.2)] 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 CRESTOR treatment should be advised not to nurse their infants.[see Use in Specific Populations (8.3)].