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This document outlines essential safety and warning information for the use of Vytorin (ezetimibe/simvastatin). It is crucial to understand these risks and precautions and to consult your healthcare provider if you have any questions or concerns.

• Muscle Pain and Damage: Vytorin may cause muscle pain, tenderness, or weakness, which can progress to a serious condition known as rhabdomyolysis. This can be life-threatening. If you are taking Vytorin, do not start any new medications without consulting your healthcare provider, as some drugs can increase the risk of muscle damage. Dosage adjustments may be necessary. Seek immediate medical help if you experience fever, muscle pain, or weakness. Individuals at higher risk include older adults, those taking 80 mg of simvastatin, individuals with kidney issues, those on medications that may cause muscle problems, and those with a history of uncontrolled hypothyroidism.

• Liver Issues: Vytorin has the potential to cause liver irritation, often detected only through blood tests. Although liver function typically returns to normal once the medication is discontinued, serious liver problems have been reported. Your healthcare provider may recommend blood tests to monitor your liver health before and during treatment. If you experience symptoms like nausea, stomach pain, jaundice, or changes in stool color, seek medical attention immediately. Those with a history of liver problems or who consume large amounts of alcohol are at increased risk.

• Elevated Blood Sugar Levels: In some cases, Vytorin may cause an increase in blood sugar levels, potentially affecting hemoglobin A1C levels. If you have pre-existing high blood sugar, inform your healthcare provider, as they might suggest more frequent monitoring. Maintaining a healthy diet and regular exercise is advisable while on this medication. Individuals with high blood sugar are at elevated risk.

Contraindications: Vytorin should not be used under the following conditions due to the risk of severe health complications:

• Concurrent use with certain medications that may lead to dangerous interactions, including azole antifungals, macrolide antibiotics, specific antiviral medications, nefazodone, cyclosporine (Neoral, Gengraf, Sandimmune), or gemfibrozil (Lopid).
• Existing liver problems.
• Pregnancy and breastfeeding.

Always consult your healthcare provider before starting Vytorin if any of these conditions apply to you.

When taking this medication, it's important to be aware of potential side effects. Common side effects include headaches, muscle pain, symptoms similar to a cold such as a runny nose and cough, and diarrhea. These effects are generally mild but if they persist or worsen, it is advisable to consult your healthcare provider for guidance.

Some individuals may experience tiredness, pain in the arms, hands, legs, or feet, and skin rashes or changes. Again, these are typically not severe, but monitoring your symptoms and consulting a professional if they become concerning is recommended.

In rare cases, more serious side effects can occur. Muscle problems, such as rhabdomyolysis, may arise, characterized by muscle weakness, pain, fever, unusual tiredness, and dark brown urine. Serious liver issues might also develop, presenting symptoms like persistent nausea or vomiting, abdominal swelling, yellowing of the skin or eyes, pale stools, or dark urine.

An allergic reaction, although very rare, can manifest as a rash, itching, swelling, dizziness, or trouble breathing, which requires immediate medical attention. Always stay vigilant and seek medical care if you notice any severe or unusual symptoms.

Some drugs and products may interact with this medication, including blood thinners like warfarin, cyclosporine, danazol, daptomycin, and gemfibrozil. Certain medications can alter how simvastatin is processed in your body, potentially impacting its effectiveness. These include specific antifungal medications (such as itraconazole, ketoconazole, posaconazole, voriconazole), cobicistat, colchicine, and certain antibiotics like clarithromycin and erythromycin. Additionally, nefazodone, HIV protease inhibitors like nelfinavir, ritonavir, and telithromycin may also have an effect.

Individuals of Chinese descent should avoid taking niacin in high doses (1 gram or more) for cholesterol management while on this medication, as it may heighten the risk of side effects, particularly muscle issues. It is important to consult your doctor for guidance. Furthermore, do not use red yeast rice products when taking ezetimibe/simvastatin because they may contain lovastatin, a statin that, when combined with ezetimibe/simvastatin, can increase the risk of severe muscle and liver complications.