Drug Detail:Ezetimibe and rosuvastatin (Ezetimibe and rosuvastatin [ e-zet-i-mibe-and-roe-soo-va-stat-in ])
Drug Class: Antihyperlipidemic combinations
Usual Adult Dose for Hyperlipidemia
1 tablet orally once a day
Tablet strengths available:
- Rosuvastatin 5 mg/ezetimibe 10 mg
- Rosuvastatin 10 mg/ezetimibe 10 mg
- Rosuvastatin 20 mg/ezetimibe 10 mg
- Rosuvastatin 40 mg/ezetimibe 10 mg
Comments:
- Patient's dose should be individualized based on indication, low-density lipoprotein cholesterol (LDL-C), and individual risk for cardiovascular events.
- LDL-C may be assessed early as 2 weeks after initiating therapy.
- Dose should be adjusted based on LDL-C levels.
Uses:
- As an adjunct to diet to reduce LDL-C in patients with primary non-familial hyperlipidemia.
- Alone or as an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).
Usual Adult Dose for Homozygous Familial Hypercholesterolemia
1 tablet orally once a day
Tablet strengths available:
- Rosuvastatin 5 mg/ezetimibe 10 mg
- Rosuvastatin 10 mg/ezetimibe 10 mg
- Rosuvastatin 20 mg/ezetimibe 10 mg
- Rosuvastatin 40 mg/ezetimibe 10 mg
Comments:
- Patient's dose should be individualized based on indication, low-density lipoprotein cholesterol (LDL-C), and individual risk for cardiovascular events.
- LDL-C may be assessed early as 2 weeks after initiating therapy.
- Dose should be adjusted based on LDL-C levels.
Uses:
- As an adjunct to diet to reduce LDL-C in patients with primary non-familial hyperlipidemia.
- Alone or as an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).
Renal Dose Adjustments
Mild to moderate renal impairment: No adjustment recommended
Severe renal impairment (CrCl less than 30 mL/min/1.73 m2) and not on hemodialysis:
- Initial dose: rosuvastatin 5 mg/ezetimibe 10 mg orally once a day; Maximum dose: rosuvastatin 10 mg/ezetimibe 10 mg orally once a day
Liver Dose Adjustments
Use is contraindicated in patient's with acute liver failure or decompensated cirrhosis
Dose Adjustments
Asian Patients:
- Initial dose: rosuvastatin 5 mg/ezetimibe 10 mg orally once a day
- For patients who are not adequately controlled at a dose of rosuvastatin 20 mg/ezetimibe 10 mg; consider the risk/benefit of treatment
Concomitant use with darolutamide:
- Do not exceed rosuvastatin 5 mg/ezetimibe 10 mg orally once a day
Concomitant use with regorafenib:
- Do not exceed rosuvastatin 10 mg/ezetimibe 10 mg orally once a day
Concomitant use with cyclosporine or gemfibrozil:
- Not recommended
Concomitant use with Antiviral Medications:
- Use with sofosbuvir/velpatasvir/voxilaprevir and ledipasvir/sofosbuvir is not recommended
- Use with simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, atazanavir/ritonavir, and lopinavir/ritonavir:
- Initiate rosuvastatin 5 mg/ezetimibe 10 mg orally once a day; maximum dose rosuvastatin 10 mg/ezetimibe 10 mg orally once a day
Precautions
CONTRAINDICATIONS:
- Acute liver failure or decompensated cirrhosis
- Hypersensitivity to active substances or any product ingredients; hypersensitivity reactions have included anaphylaxis, angioedema, and erythema multiforme
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take 1 tablet orally once a day
- Swallow tablet whole at any time of day, with or without food; do not crush, dissolve, or chew tablets
- For patients taking a bile acid sequestrant: This drug should be taken at least 2 hours before or 4 hours after the bile acid sequestrant
- For patients taking an aluminum and magnesium hydroxide combination antacid, administer this drug at least 2 hours before the antacid
MISSED DOSE: If a dose is missed, skip the missed dose, and resume regular schedule
Storage requirements:
- Protect from light and moisture; dispense in original container
- Once the bottle is opened, the tablets should be used within 30 days
General:
- To prevent of reduce the risk of myopathy and rhabdomyolysis, temporarily discontinue this drug in patients experiencing an acute or serious conditions that place them at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.
Monitoring:
- Monitor LDL-C
- Monitor for signs and symptoms of myopathy, particularly during initiation and during upward titration
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
- Patients should understand the risks of myopathy and rhabdomyolysis; they should be instructed to inform their healthcare provider of all medications they are taking, including over-the-counter and herbal products, and to report any unexplained muscle pain, tenderness, and weakness, especially if accompanied by malaise or fever.
- Counsel patients regarding risks of alcohol use with this drug.
