Fenoglide 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?
This medication 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?
Fenoglide is a peroxisome proliferator receptor alpha (PPARα) activator indicated: as an adjunct to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia when response to diet and non-pharmacological interventions alone has been inadequate. (1.1)as an adjunct to diet to treat patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. (1.2) Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2.
What should I know before taking it?
Fenoglide is contraindicated in patients with severe renal dysfunction, including those receiving dialysis [see Clinical Pharmacology (12.3).] Fenoglide is contraindicated in patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.1).] Fenoglide is contraindicated in patients with gallbladder disease [see Warnings and Precautions (5.2).] Fenoglide is contraindicated in nursing mothers [see Use in Specific Populations (8.3).] Fenoglide is contraindicated in patients who have a known hypersensitivity to fenofibrate, such as severe skin rashes, including Stevens-Johnson syndrome.
What important warnings are listed?
Fenofibrate can increase serum transaminases. Liver tests should be periodically monitored. (5.1)Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. (5.2)Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. (5.3)Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.
How is this medication usually taken?
40 mg: White to off-white oval tablets. Debossed "FLO".120 mg: White to off-white oval tablets. Debossed "FHI".
What side effects are listed?
The most common adverse reactions (> 2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Shore Therapeutics Drug Safety Department at 1-888-743-0571 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What interactions are listed?
Coumarin Anticoagulants (7.1)Cyclosporine (7.2)HMG-CoA Reductase Inhibitors (7.3)Bile-Acid Resins (7.4)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b38489c0-ee7b-11df-b958-0002a5d5c51b
⚠️ 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.