Gemfibrozil Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Gemfibrozil is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride.
What should I know before taking it?
Hepatic or severe renal dysfunction, including primary biliary cirrhosis.Preexisting gallbladder disease (see WARNINGS ).Hypersensitivity to gemfibrozil.Combination therapy of gemfibrozil with simvastatin (see WARNINGS and PRECAUTIONS ).Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS ).Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS ). Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS ).
What important warnings are listed?
1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1,000 subjects with previous myocardial infarction were treated for five years with clofibrate. There was no difference in mortality between the clofibrate-treated subjects and 3,000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5,000 subjects without known coronary heart disease.
How is this medication usually taken?
The recommended dose for adults is 1,200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).
What side effects are listed?
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2,046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group: GEMFIBROZIL ( N = 2,046 ) PLACEBO ( N = 2,035 ) Frequency in percent of subjects Gastrointestinal reactions 34.2 23.8 Dyspepsia 19.6 11.9 Abdominal pain 9.8 5.6 Acute appendicitis 1.2 0.6 (histologically confirmed in most cases where data were available) Atrial fibrillation 0.7 0.1 Adverse events reported by more than 1% of subjects, but without a significant difference between groups: Diarrhea 7.2 6.5 Fatigue 3.8 3.5.
What interactions are listed?
The FDA/DailyMed label should be reviewed for complete details.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=05bfbcdc-03ab-4fba-9582-980602410ef9
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.