Pravastatin contraindications

Pravastatin
PRAVACHOL ® 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
Patient Counseling Information
Labels and Packages
Clinical Trials on Pravastatin
ClinicalTrials.gov

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

Contraindications

Hypersensitivity

Hypersensitivity to any component of this medication.

Liver

Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions (5.2)].

=Pregnancy

=

Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperCholesterolemia. Cholesterol and other products of Cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since statins decrease Cholesterol synthesis and possibly the synthesis of other biologically active substances derived from Cholesterol, they are contraindicated during pregnancy and in nursing mothers. PRAVASTATIN SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING AGE ONLY WHEN SUCH PATIENTS ARE HIGHLY UNLIKELY TO CONCEIVE AND HAVE BEEN INFORMED OF THE POTENTIAL HAZARDS. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

Nursing Mothers

A small amount of pravastatin is excreted in human breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require PRAVACHOL treatment should not breast-feed their infants [see Use in Specific Populations (8.3)].