Description
Ezetimibe and simvastatin combination is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood in patients with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH). This medicine may help prevent certain types of heart problems in patients at high risk.
Ezetimibe is a cholesterol absorption inhibitor. This medicine will reduce the absorption of cholesterol from foods and the production of cholesterol in your body.
Simvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ezetimibe and simvastatin combination for the treatment of heterozygous familial hypercholesterolemia (HeFH) and high cholesterol in the blood in children younger than 10 years of age and for the treatment of homozygous familial hypercholesterolemia (HoFH) in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ezetimibe and simvastatin combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or muscle problems (eg, myopathy), which may require caution in patients receiving ezetimibe and simvastatin combination.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Amprenavir
- Atazanavir
- Boceprevir
- Ceritinib
- Clarithromycin
- Cobicistat
- Cyclosporine
- Danazol
- Darunavir
- Erythromycin
- Fosamprenavir
- Gemfibrozil
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Lopinavir
- Mibefradil
- Mifepristone
- Nefazodone
- Nelfinavir
- Nirmatrelvir
- Paritaprevir
- Posaconazole
- Ribociclib
- Ritonavir
- Saquinavir
- Telaprevir
- Telithromycin
- Tipranavir
- Voriconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Adagrasib
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amiodarone
- Amlodipine
- Asciminib
- Avacopan
- Azithromycin
- Bempedoic Acid
- Bezafibrate
- Carbamazepine
- Ceftobiprole Medocaril
- Cholestyramine
- Ciprofibrate
- Ciprofloxacin
- Clofibrate
- Colchicine
- Colesevelam
- Colestipol
- Conivaptan
- Dabrafenib
- Dalfopristin
- Danicopan
- Daptomycin
- Darolutamide
- Delavirdine
- Digoxin
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Diltiazem
- Dronedarone
- Duvelisib
- Elafibranor
- Elexacaftor
- Eltrombopag
- Encorafenib
- Eslicarbazepine Acetate
- Fedratinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Albiglutide
- Alitretinoin
- Apalutamide
- Bosentan
- Cilostazol
- Clopidogrel
- Efavirenz
- Fostemsavir
- Interferon Beta
- Levothyroxine
- Mavacamten
- Oat Bran
- Oxcarbazepine
- Pectin
- St John's Wort
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Cranberry Juice
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of or
- Chinese ancestry or
- Diabetes or
- Hypothyroidism (an underactive thyroid), not well controlled or
- Liver disease, history of—Use with caution. May cause side effects to become worse.
- Electrolyte disorders, severe or
- Endocrine disorders, severe or
- Epilepsy (seizures), not well-controlled or
- Hypovolemia, severe or
- Kidney disease, severe or
- Major surgery or trauma, recent or
- Metabolic disorders, severe or
- Sepsis (severe infection in the blood) or
- Surgery, major or
- Trauma—Patients with these conditions may be at risk for muscle or kidney problems.
- Liver disease, active or
- Liver enzymes elevated—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.
You may take the tablet with or without food.
If you are taking diltiazem (Cardizem®), dronedarone (Multaq®), or verapamil (Calan®, Isoptin®, Verelan®) together with ezetimibe and simvastatin combination, your dose should not be higher than ezetimibe 10 milligrams (mg) plus simvastatin 10 mg per day, unless otherwise directed by your doctor. Do not use more than ezetimibe 10 mg plus simvastatin 20 mg per day together with amiodarone (Cordarone®), amlodipine (Norvasc®), lomitapide (Juxtapid™), or ranolazine (Ranexa®). When used together with higher doses of simvastatin, these medicines may increase your risk of muscle injury and could result in kidney problems.
If you are also using cholestyramine (Questran®), take it at least 2 hours after or 4 hours before you take this medicine.
Tell your doctor if you regularly drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1 quart each day) while taking this medicine may increase your risk of muscle injury and could result in kidney problems.
Do not drink large amounts of alcohol with this medicine. This could cause unwanted effects on the liver.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For heterozygous familial hypercholesterolemia (HeFH):
- Adults and children 10 years of age and older—At first, one tablet once a day in the evening. Each tablet contains 10 milligrams (mg) ezetimibe and 10 mg simvastatin. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg ezetimibe and 40 mg simvastatin per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For homozygous familial hypercholesterolemia (HoFH)
- Adults—At first, one tablet once a day in the evening. Each tablet contains 10 milligrams (mg) ezetimibe and 10 mg simvastatin. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg ezetimibe and 40 mg simvastatin per day.
- Children—Use and dose must be determined by your doctor.
- For heterozygous familial hypercholesterolemia (HeFH):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use ezetimibe and simvastatin combination if you are also taking boceprevir (Victrelis®), cobicistat-containing products (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (eg, clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicines to treat HIV/AIDS (eg, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines together with ezetimibe and simvastatin may increase your risk of muscle injury and could result in kidney problems.
Chinese patients who are taking large amounts of niacin (greater than 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®).
Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM). Myopathy is more common when high doses of simvastatin (80 milligrams) with ezetimibe (10 mg) are used, but some people get myopathy with lower doses.
Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, a major injury, or you develop other serious health problems.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Bloating
- chest tightness
- chills
- constipation
- darkened urine
- fast heartbeat
- fever
- hives, itching, skin rash
- hoarseness
- indigestion
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- redness of the skin
- stiffness
- stomach fullness
- swelling of the eyelids, face, lips, hands, or feet
- trouble breathing or swallowing
- vomiting
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Body aches or pain
- cough
- diarrhea
- difficulty with moving
- ear congestion
- general feeling of discomfort or illness
- headache
- loss of voice
- muscle aches and pains or cramping
- muscle stiffness
- pain in the arms or legs
- runny or stuffy nose
- shivering
- sneezing
- sore throat
- sweating
- swollen joints
- trouble sleeping
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20062939
