Ezetimibe Dosing Recommendations
The recommended dose of ezetimibe is 10 mg orally once daily, administered with or without food, regardless of age, diabetes status, or renal function. 1
Standard Dosing
- Ezetimibe 10 mg once daily is the only approved dose for all adult patients with primary hyperlipidemia. 1
- The medication can be taken in the morning or evening without regard to meals. 2
- If a dose is missed, take it as soon as possible; do not double the next dose. 1
No Dose Adjustments Required
- Age: No dosage adjustment is necessary based on patient age. 2
- Diabetes: The standard 10 mg daily dose applies to patients with diabetes mellitus. 3
- Renal impairment: No dose adjustment is needed for mild-to-severe renal insufficiency. 2
- Hepatic impairment: No adjustment required for mild hepatic impairment. 2
Clinical Indications by Risk Category
Very High-Risk ASCVD Patients
- Add ezetimibe 10 mg daily to maximally tolerated statin therapy when LDL-C remains ≥70 mg/dL (≥1.8 mmol/L). 3
- Very high-risk includes multiple major ASCVD events or one major event plus multiple high-risk conditions (age ≥65, diabetes, hypertension, CKD with eGFR 15-59 mL/min/1.73 m²). 3
Severe Primary Hypercholesterolemia (LDL-C ≥190 mg/dL)
- Add ezetimibe 10 mg daily when patients achieve <50% LDL-C reduction on maximally tolerated statin and/or LDL-C remains ≥100 mg/dL (≥2.6 mmol/L). 3
- This is a Class IIa recommendation with Level B evidence. 3
Diabetes with High Cardiovascular Risk
- Consider adding ezetimibe 10 mg daily to maximally tolerated statin in adults with diabetes and 10-year ASCVD risk ≥20% to achieve ≥50% LDL-C reduction. 3
- This is a Class IIb recommendation with Level C evidence. 3
Timing and Monitoring
- Assess LDL-C as early as 4 weeks after initiating ezetimibe. 1
- Maximum LDL-C reduction occurs within 1-2 hours post-administration, with steady-state achieved after repeated once-daily dosing due to the 22-hour terminal half-life. 2
- Ezetimibe provides an additional 15-25% LDL-C reduction when added to statin therapy. 4, 5
Critical Drug Interaction
- Administer ezetimibe at least 2 hours before or 4 hours after bile acid sequestrants (e.g., cholestyramine) to avoid significantly reduced bioavailability. 1, 2
- Concomitant administration with statins, fibrates, antacids, or food does not require timing adjustments. 2
Common Pitfall to Avoid
Do not increase the ezetimibe dose above 10 mg daily. Higher doses (up to 40 mg) have been studied but offer no additional clinical benefit due to the flat dose-response curve, and 10 mg remains the only FDA-approved dose. 1, 2, 6