Fixed-dose combination
Ezetimibe and Simvastatin is a fixed-dose combination of a dietary cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C). MedsAcross supplies Ezetimibe and Simvastatin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. 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).
Source: US FDA prescribing information
VYTORIN Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. VYTORIN contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. Ezetimibe Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood.
Source: US FDA prescribing information
Important Dosage and Administration Information: Take VYTORIN orally once daily in the evening with or without food. Maximum recommended dosage is VYTORIN 10/40 mg once daily. VYTORIN 10/80 mg daily dosage is restricted to patients who have been taking VYTORIN 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving VYTORIN 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 2 weeks after initiating VYTORIN, and adjust the dosage if necessary. Adults: Recommended dosage range of 10/10 mg to 10/40 mg once daily.
Source: US FDA prescribing information
VYTORIN is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone). Concomitant use of cyclosporine, danazol, or danazol. Acute liver failure or decompensated cirrhosis. Hypersensitivity to simvastatin, ezetimibe, or any excipients in VYTORIN. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome, have been reported. Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications and nefazodone). Concomitant use of cyclosporine, danazol or gemfibrozil.
Source: US FDA prescribing information
Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher VYTORIN dosage. Chinese patients may be at higher risk for myopathy. Discontinue VYTORIN if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue VYTORIN 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 VYTORIN dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue VYTORIN if IMNM is suspected.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis Immune-Mediated Necrotizing Myopathy Hepatic Dysfunction Increases in HbA1c and Fasting Serum Glucose Levels Common (incidence ≥2% and greater than placebo) adverse reactions in clinical trials: headache, increased ALT, myalgia, upper respiratory tract infection, and diarrhea.
Source: US FDA prescribing information
VYTORIN See full prescribing information for details regarding concomitant use of VYTORIN with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. Cholestyramine: Combination decreases exposure of ezetimibe. Coumarin Anticoagulants: Obtain INR before VYTORIN initiation and monitor INR during VYTORIN dosage initiation or adjustment. Digoxin: During VYTORIN initiation, monitor digoxin levels. Fenofibrates: Combination increases exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.
Source: US FDA prescribing information
Store at 68°F to 77°F (20°C to 25°C).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Ezetimibe and Simvastatin, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Ezetimibe and Simvastatin 10 mg/80 mg tabletOralGeneric name | Ezetimibe and Simvastatin | — | US FDA | Available on request |
| Ezetimibe and Simvastatin 10 mg/40 mg tabletOralGeneric name | Ezetimibe and Simvastatin | — | US FDA | Available on request |
| Ezetimibe and Simvastatin 10 mg/20 mg tabletOralGeneric name | Ezetimibe and Simvastatin | — | US FDA | Available on request |
| Ezetimibe and Simvastatin 10 mg/10 mg tabletOralGeneric name | Ezetimibe and Simvastatin | — | US FDA | Available on request |
| Vytorin 10 mg/10 mg tabletOral | Ezetimibe and Simvastatin | Organon | US FDA | Available on request |
| Vytorin 10 mg/20 mg tabletOral | Ezetimibe and Simvastatin | Organon | US FDA | Available on request |
| Vytorin 10 mg/40 mg tabletOral | Ezetimibe and Simvastatin | Organon | US FDA | Available on request |
| Vytorin 10 mg/80 mg tabletOral | Ezetimibe and Simvastatin | Organon | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 23 July 2004 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Ezetimibe and Simvastatin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 8 presentations of Ezetimibe and Simvastatin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ezetimibe and Simvastatin, including Vytorin.
Yes. The US FDA first approved Ezetimibe and Simvastatin on 23 July 2004, according to Drugs@FDA.
No listed presentation of Ezetimibe and Simvastatin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ezetimibe and Simvastatin is classified under ATC code C10BA02 (Ezetimibe and Simvastatin).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.