Fluvastatin patient counseling information

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Fluvastatin
LESCOL® 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 Fluvastatin sodium
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

Information for Patients

Patients taking LESCOL/LESCOL XL should be advised that high cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel to determine goal attainment.

Patients should be advised about substances they should not take concomitantly with LESCOL/LESCOL XL [see Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking LESCOL/LESCOL XL.

Muscle Pain

Patients starting therapy with LESCOL/LESCOL XL should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing LESCOL/LESCOL XL.

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of LESCOL/LESCOL XL and if signs or symptoms of liver injury occur. All patients treated with LESCOL/LESCOL XL should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using LESCOL/LESCOL XL. Discuss future pregnancy plans with your patients, and discuss when to stop taking LESCOL/LESCOL XL if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking LESCOL/LESCOL XL and call their healthcare professional.

Breastfeeding

Women who are breastfeeding should not use LESCOL/LESCOL XL. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional. [1]

References

  1. "LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]". Retrieved 12 February 2014.

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