Vytorin

Dosage Forms And Strengths

• VYTORIN® 10/10, (ezetimibe 10 mg and simvastatin 10 mg tablets) are white to off-white capsuleshaped tablets with code “311” on one side.
• VYTORIN® 10/20, (ezetimibe 10 mg and simvastatin 20 mg tablets) are white to off-white capsuleshaped tablets with code “312” on one side.
• VYTORIN® 10/40, (ezetimibe 10 mg and simvastatin 40 mg tablets) are white to off-white capsuleshaped tablets with code “313” on one side.
• VYTORIN® 10/80, (ezetimibe 10 mg and simvastatin 80 mg tablets) are white to off-white capsuleshaped tablets with code “315” on one side.

Storage And Handling

No. 3873 - Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code “311” on one side.

They are supplied as follows:

NDC 66582-311-31 bottles of 30
NDC 66582-311-54 bottles of 90
NDC 66582-311-82 bottles of 1000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-311-87 bottles of 10,000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)

No. 3874 - Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code “312” on one side.

They are supplied as follows:

NDC 66582-312-31 bottles of 30
NDC 66582-312-54 bottles of 90
NDC 66582-312-82 bottles of 1000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-312-87 bottles of 10,000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)

No. 3875 - Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code “313” on one side.

They are supplied as follows:

NDC 66582-313-31 bottles of 30
NDC 66582-313-54 bottles of 90
NDC 66582-313-74 bottles of 500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-313-86 bottles of 5000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)

No. 3876 - Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code “315” on one side.

They are supplied as follows:

NDC 66582-315-31 bottles of 30
NDC 66582-315-54 bottles of 90
NDC 66582-315-74 bottles of 500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)
NDC 66582-315-66 bottles of 2500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.)

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.

Storage Of 10,000, 5000, And 2500 Count Bottles

Store bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightlyclosed, light-resistant container. Entire contents must be repackaged immediately upon opening.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Oct 2016

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Certain anti-fungal medicines including:
  • itraconazole
  • ketoconazole
  • posaconazole
• HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir),
• Certain antibiotics, including:
  • erythromycin
  • clarithromycin
  • telithromycin
• nefazodone
• A fibric acid medicine for lowering cholesterol called gemfibrozil
• cyclosporine
• danazol

Taking Vytorin with certain substances can increase the risk of muscle problems. It is especially important to tell your doctor if you take:

• fibric acid derivatives (such as fenofibrate)
• amiodarone (a drug used to treat an irregular heartbeat)
• verapamil, diltiazem, amlodipine, or ranolazine (drugs used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
• large quantities of grapefruit juice (more than 1 quart daily)
• colchicine (a medicine used to treat gout)
• voriconazole (an anti-fungal medicine)
• large doses of niacin or nicotinic acid

Tell your doctor if you are taking niacin or a niacin-containing product, as this may increase your risk of muscle problems, especially if you are Chinese.

It is also important to tell your doctor if you are taking coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).

Before receiving this medication, tell your doctor:

• about all the medicines you take, including any prescription and nonprescription medicines, vitamins, and herbal supplements
• about all of your medical conditions including allergies
• if you drink substantial quantities of alcohol or if you have ever had liver problems
• if you are pregnant or breastfeeding

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ezetimibe and simvastatin combination in children 10 to 17 years of age. However, safety and efficacy of ezetimibe and simvastatin combination in children younger than 10 years of age 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 muscle problems, which may require caution in patients receiving ezetimibe and simvastatin combination.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

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
• Clarithromycin
• Cobicistat
• Cyclosporine
• Danazol
• Darunavir
• Erythromycin
• Fosamprenavir
• Gemfibrozil
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Paritaprevir
• Posaconazole
• 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
• Amiodarone
• Amlodipine
• Azithromycin
• Bezafibrate
• Carbamazepine
• Ceritinib
• Ciprofibrate
• Ciprofloxacin
• Clofibrate
• Colchicine
• Conivaptan
• Dabigatran Etexilate
• Dalfopristin
• Daptomycin
• Delavirdine
• Diltiazem
• Eltrombopag
• Eslicarbazepine Acetate
• Fenofibrate
• Fenofibric Acid
• Fluconazole
• Fusidic Acid
• Gemfibrozil
• Lomitapide
• Lumacaftor
• Niacin
• Pazopanib
• Quinupristin
• Ranolazine
• Risperidone
• Simeprevir
• Tadalafil
• Verapamil
• Warfarin

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
• Bosentan
• Cholestyramine
• Clopidogrel
• Colestipol
• Cyclosporine
• Dasatinib
• Digoxin
• Dronedarone
• Efavirenz
• Fenofibrate
• Fenofibric Acid
• Fosphenytoin
• Interferon Beta
• Levothyroxine
• Oat Bran
• Oxcarbazepine
• Pectin
• Phenytoin
• Rifampin
• St John's Wort
• Ticagrelor

Interactions with Food/Tobacco/Alcohol

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
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Major surgery or trauma, recent or
• Metabolic disorders, severe or
• Sepsis (severe infection in the blood)—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.

• If you have an allergy to ezetimibe, simvastatin, or any other part of Vytorin (ezetimibe and simvastatin).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take Vytorin.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with Vytorin. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this medicine.
• If you have liver disease or raised liver enzymes.

This is not a list of all drugs or health problems that interact with Vytorin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking Vytorin (ezetimibe and simvastatin) as you have been told by your doctor or other health care provider, even if you feel well.
• Take in the evening.
• Take with or without food.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

NDC 66582-311-31

Vytorin®
(ezetimibe and
simvastatin) tablets

10 mg /10 mg

Each tablet contains 10 mg ezetimibe and
10 mg simvastatin.

Rx only

30 Tablets

NDC 66582-315-31

Vytorin®
(ezetimibe and
simvastatin) tablets

10 mg /80 mg

Each tablet contains 10 mg ezetimibe and
80 mg simvastatin.

Rx only

30 Tablets

Applies to ezetimibe / simvastatin: oral tablet

Along with its needed effects, ezetimibe / simvastatin 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 while taking ezetimibe / simvastatin:

• Abdominal or stomach fullness
• bloating
• chills
• constipation
• darkened urine
• fast heartbeat
• fever
• hives
• hoarseness
• indigestion
• itching
• 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
• rash
• redness of the skin
• shortness of breath
• stiffness
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble breathing or swallowing
• vomiting
• yellow eyes or skin

Some side effects of ezetimibe / simvastatin 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:

• Body aches or pain
• cough
• diarrhea
• difficulty with breathing
• difficulty with moving
• ear congestion
• general feeling of discomfort or illness
• headache
• loss of voice
• muscle aches and pains or cramping
• muscle stiffness
• nasal congestion
• pain in the arms or legs
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• swollen joints
• trouble sleeping
• unusual tiredness or weakness

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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