Clinical Information
Gen. Code and Des.
51214 ezetimibe ORAL TABLET 10 MG
GCN and Des.
18387 ezetimibe ORAL TABLET 10 MG
Strength
10MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24060500 CHOLESTEROL ABSORPTION INHIBITORS
Active Ingredients
9817 ezetimibe 163222331
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398
These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS.
EZETIMIBE tablets, for oral use
Initial U.S. Approval: 2002
INDICATIONS AND USAGE
Ezetimibe tablets are an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to:
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) ( 1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate ( 1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin ( 1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) ( 1.3)
Limitations of Use ( 1.4)
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
DOSAGE AND ADMINISTRATION
One 10-mg tablet once daily, with or without food ( 2.1)
Dosing of ezetimibe tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. ( 2.3, 7.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg ( 3)
CONTRAINDICATIONS
Statin contraindications apply when ezetimibe tablets are used with a statin:
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4, 5.2)
Women who are pregnant or may become pregnant ( 4, 8.1)
Nursing mothers ( 4, 8.3)
Known hypersensitivity to product components ( 4, 6.2)
WARNINGS AND PRECAUTIONS
Ezetimibe is not recommended in patients with moderate or severe hepatic impairment. ( 5.4, 8.7, 12.3)
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur when ezetimibe is added to a statin. Therefore, when ezetimibe is added to statin therapy, monitor hepatic transaminase levels before and during treatment according to the recommendations for the individual statin used. ( 5.2)
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis):
Cases of myopathy and rhabdomyolysis have been reported in patients treated with ezetimibe coadministered with a statin and with ezetimibe administered alone. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. ( 5.3, 6.2)
ADVERSE REACTIONS
Common adverse reactions in clinical trials:
Ezetimibe coadministered with a statin (incidence ≥2% and greater than statin alone):
nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, and diarrhea ( 6)
Ezetimibe administered alone (incidence ≥2% and greater than placebo):
upper respiratory tract infection, diarrhea, arthralgia, sinusitis, and pain in extremity ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or www.accordhealthcare.us or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Cyclosporine: Combination increases exposure of ezetimibe and cyclosporine. Cyclosporine concentrations should be monitored in patients taking ezetimibe concomitantly. ( 7.1, 12.3)
Fenofibrate: Combination increases exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. ( 6.1, 7.3)
Fibrates: Coadministration of ezetimibe with fibrates other than fenofibrate is not recommended until use in patients is adequately studied. ( 7.2)
Cholestyramine: Combination decreases exposure of ezetimibe. ( 2.3, 7.4, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2018
