Recommended Dosage of Ezetimibe
The recommended dosage of ezetimibe is 10 mg orally once daily, administered with or without food. 1, 2
Administration Details
- Ezetimibe can be taken at any time of day, as studies have shown no significant difference in efficacy between morning and evening administration 3
- When taking ezetimibe with statins, they can be administered at the same time 1
- When taking ezetimibe with bile acid sequestrants, ezetimibe should be taken at least 2 hours before or 4 hours after the bile acid sequestrant to avoid decreased bioavailability 1, 2
Clinical Evidence Supporting the 10 mg Dose
The 10 mg daily dosage is supported by multiple high-quality guidelines and the FDA label:
- The American College of Cardiology recommends 10 mg daily as the standard dose for adults 4, 1
- The FDA-approved prescribing information specifies 10 mg once daily as the recommended dose 2
- In the IMPROVE-IT trial, which demonstrated cardiovascular outcome benefits, ezetimibe was used at the 10 mg daily dose in combination with simvastatin 4
Alternative Dosing Considerations
While 10 mg is the standard dose, some research has explored other dosing options:
- Half-dose (5 mg) ezetimibe has shown effectiveness in some Asian patients with severe hyperlipidemia, producing a 24% reduction in LDL-C when added to statins, comparable to the effect seen with 10 mg dosing 5
- Higher doses (20 mg) have been studied in small trials and may provide additional LDL-C lowering (approximately 10.3% further reduction) in patients already on statins, but this is not an FDA-approved dosage 6
Monitoring and Safety
- Liver function tests should be monitored as clinically indicated when taking ezetimibe with a statin 1
- Ezetimibe should be discontinued if persistent ALT elevations ≥3 times the upper limit of normal occur 2
- Common side effects include upper respiratory tract infection, diarrhea, arthralgia, back pain, pain in extremities, and muscle spasms 1
Special Populations
- No dosage adjustment is necessary for patients with mild hepatic impairment or mild-to-severe renal insufficiency 7
- No clinically significant effects of age, sex, or race on ezetimibe pharmacokinetics have been observed 7
The 10 mg once-daily dosage remains the standard recommendation across all major guidelines and the FDA label, providing the optimal balance of efficacy and safety for most patients requiring ezetimibe therapy.