Ezetimibe
Dosing in kidney impairment
Recommended Dosage in Patients with Renal Impairment Renal impairment is a risk factor for statin-associated myopathy. Doses of ezetimibe and simvastatin tablets exceeding 10/20 mg should be used with caution and close monitoring in patients with moderate to severe renal impairment [see Warnings and Precautions and Use in Specific Populations] .
There are no dosage adjustment recommendations for patients with mild renal impairment.
Dosing in liver impairment
Hepatic Impairment Ezetimibe and simvastatin tablets is contraindicated in patients with acute liver failure or decompensated cirrhosis. [See Contraindications and Warnings and Precautions.]
Preparation and administration
Important Dosage and Administration Information
Take ezetimibe and simvastatin tablets orally once daily in the evening with or without food.
The maximum recommended dosage is ezetimibe and simvastatin tablets 10/40 mg once daily. The ezetimibe and simvastatin tablets 10/80 mg daily dosage is restricted to adult patients who have been taking ezetimibe and simvastatin tablets 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions] .
For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving ezetimibe and simvastatin tablets 10/40 mg daily, prescribe alternative LDL-C-lowering treatment.
If as dose is missed, take the missed dose as soon as possible. Do not double the next dose.
Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe and simvastatin tablets, and adjust the dosage if necessary.