Niacin/lovastatin patient counseling information

Niacin/lovastatin
ADVICOR® 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 Niacin/lovastatin
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 of the following:

• to report promptly unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing ADVICOR (see WARNINGS, Myopathy/Rhabdomyolysis);
• to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice (see WARNINGS, Liver Dysfunction);
• to take ADVICOR at bedtime, with a low-fat snack. Administration on an empty stomach is not recommended;
• to carefully follow the prescribed dosing regimen (see DOSAGE AND ADMINISTRATION);

that flushing is a common side effect of niacin therapy that usually subsides after several weeks of consistent niacin use. Flushing may last for several hours after dosing, may vary in severity, and will, by taking ADVICOR at bedtime, most likely occur during sleep. If awakened byflushing, especially if taking antihypertensives, rise slowly to minimize the potential for dizziness and/or syncope;

• that taking aspirin (up to approximately 30 minutes before taking ADVICOR) may minimize flushing;
• to avoid ingestion of alcohol, hot beverages and spicy foods around the time of ADVICOR administration, to minimize flushing;
• should not be administered with grapefruit juice;
• that if ADVICOR therapy is discontinued for an extended length of time, their physician should be contacted prior to re-starting therapy; re-titration is recommended (see DOSAGE AND ADMINISTRATION);
• to notify their physician if they are taking vitamins or other nutritional supplements containing niacin or related compounds such as nicotinamide (see Drug Interactions);
• to notify their physician if symptoms of dizziness occur;
• if diabetic, to notify their physician of changes in blood glucose;
• that ADVICOR tablets should not be broken, crushed, or chewed, but should be swallowed whole.