Vytorin Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Ezetimibe and Simvastatin Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated: • As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial.
What should I know before taking it?
Ezetimibe and simvastatin tablets is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, antiviral medications, and nefazodone) [see Drug Interactions (7.1)]. Concomitant use of cyclosporine, danazol, or danazol [see Drug Interactions (7.1)]. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)].Hypersensitivity to simvastatin, ezetimibe, or any excipients in ezetimibe and simvastatin tablets. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome, have been reported [see Adverse Reactions (6.2)].
What important warnings are listed?
Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher ezetimibe and simvastatin dosage. Chinese patients may be at higher risk for myopathy. Discontinue ezetimibe and simvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ezetimibe and simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing ezetimibe and simvastatin dosage. Instruct patients to.
How is this medication usually taken?
Ezetimibe and simvastatin tablets 10/10, (ezetimibe, USP 10 mg/simvastatin, USP 10 mg tablets) are white to off-white, capsule shaped tablets debossed with “A029” on one side and plain on other side.10/20, (ezetimibe, USP 10 mg/simvastatin, USP 20 mg tablets) are white to off-white, capsule shaped tablets debossed with “A028” on one side and plain on other side.10/40, (ezetimibe, USP 10 mg/simvastatin, USP 40 mg tablets) are white to off-white, capsule shaped tablets and debossed with “A027” on one side and plain on other side.10/80, (ezetimibe, USP 10 mg/simvastatin, USP 80 mg tablets) are white to off-white, capsule shaped tablets debossed with “A026” on one side and plain on other side.
What side effects are listed?
The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)] Hepatic Dysfunction [see Warnings and Precautions (5.3)] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4)]
What interactions are listed?
Ezetimibe and Simvastatin Tablets
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ce219a2-1eeb-4ece-bb87-3810e593ca51
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.