"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
Patients should be advised of the following:
- to report promptly unexplained muscle pain, tenderness, or weakness (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 Dysfuction)
- 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 by flushing, 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.
Last reviewed on RxList: 4/26/2012
This monograph has been modified to include the generic and brand name in many instances.
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