What does your doctor say about your abnormal liver function test? Quit smoking and get SOME exercise!
CONTRAINDICATIONS
CRESTOR is contraindicated in patients with a known hypersensitivity to any component of
this product.
Rosuvastatin is contraindicated in patients with active liver disease or with unexplained
persistent elevations of serum transaminases (see WARNINGS, Liver Enzymes).
WARNINGS
Liver Enzymes
HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been
associated with biochemical abnormalities of liver function. The incidence of persistent
elevations (>3 times the upper limit of normal [ULN] occurring on 2 or more consecutive
occasions) in serum transaminases in fixed dose studies was 0.4, 0, 0, and 0.1% in patients
who received rosuvastatin 5, 10, 20, and 40 mg, respectively. In most cases, the elevations
were transient and resolved or improved on continued therapy or after a brief interruption in
therapy. There were two cases of jaundice, for which a relationship to rosuvastatin therapy
could not be determined, which resolved after discontinuation of therapy. There were no cases
of liver failure or irreversible liver disease in these trials.
It is recommended that liver function tests be performed before and at 12 weeks
following both the initiation of therapy and any elevation of dose, and periodically (e.g.,
semiannually) thereafter. Liver enzyme changes generally occur in the first 3 months of
treatment with rosuvastatin. Patients who develop increased transaminase levels should be
monitored until the abnormalities have resolved. Should an increase in ALT or AST of
>3 times ULN persist, reduction of dose or withdrawal of rosuvastatin is recommended.
Rosuvastatin should be used with caution in patients who consume substantial quantities of
alcohol and/or have a history of liver disease (see CLINICAL PHARMACOLOGY, Special
Populations, Hepatic Insufficiency). Active liver disease or unexplained persistent
transaminase elevations are contraindications to the use of rosuvastatin (see
CONTRAINDICATIONS).