Pravastatin patient counseling information

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]

Patient Counseling Information

Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing PRAVACHOL [see Warnings and Precautions (5.1)].

It is recommended that liver enzyme tests be performed before the initiation of PRAVACHOL, and thereafter when clinically indicated. All patients treated with PRAVACHOL should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.2)].

Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA

Product of Japan

1292354A2 Rev August 2013