Vytorin

DRUG DESCRIPTION

VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor.

The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4.

Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is:

Ezetimibe Structural Formula Illustration

Simvastatin, an inactive lactone, is hydrolyzed to the corresponding ?-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1?,3?,7?,8?(2S*,4S*),-8a?]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57.

Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is:

VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.

What are the possible side effects of ezetimibe and simvastatin (Vytorin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes);
  • ...

Read All Potential Side Effects and See Pictures of Vytorin

What are the precautions when taking ezetimibe and simvastatin (Vytorin)?

Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or simvastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more...

Read All Potential Precautions of Vytorin


Vytorin Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or simvastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this medication, especially muscle problems.

This medication must not be used during pregnancy. Simvastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Vytorin Patient Information Including Side Effects

Brand Names: Vytorin

Generic Name: ezetimibe and simvastatin (Pronunciation: ez ET i mibe and SIM va stat in)

  • What is ezetimibe and simvastatin (Vytorin)?
  • What are the possible side effects of ezetimibe and simvastatin (Vytorin)?
  • What is the most important information I should know about ezetimibe and simvastatin (Vytorin)?
  • What should I discuss with my healthcare provider before taking ezetimibe and simvastatin (Vytorin)?
  • How should I take ezetimibe and simvastatin (Vytorin)?
  • What happens if I miss a dose (Vytorin)?
  • What happens if I overdose (Vytorin)?
  • What should I avoid while taking ezetimibe and simvastatin (Vytorin)?
  • What other drugs will affect ezetimibe and simvastatin (Vytorin)?
  • Where can I get more information?

What is ezetimibe and simvastatin (Vytorin)?

Ezetimibe and simvastatin are cholesterol-lowering medicines. They reduce the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.

The combination of ezetimibe and simvastatin lowers "bad" cholesterol in the blood, (also called LDL, or low-density lipoprotein) and raises "good" cholesterol (also called HDL, or high-density lipoprotein). Lowering your LDL and raising your HDL cholesterol levels may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.

Ezetimibe and simvastatin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ezetimibe and simvastatin (Vytorin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes);
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • easy bruising or bleeding; or
  • vision problems.

Less serious side effects may include:

  • numbness or tingly feeling;
  • headache, dizziness, memory problems;
  • depressed mood;
  • constipation, diarrhea;
  • cough, sore throat, runny or stuffy nose;
  • joint pain, back pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ezetimibe and simvastatin (Vytorin)?

Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 2 weeks of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed. Your cholesterol will need to be measured with blood tests at regular intervals. Do not miss any scheduled visits to your doctor.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

Related Drug Centers
  • Vytorin


Related Drugs Index: