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The following safety warnings and precautions are essential for the safe use of Vytorin (ezetimibe/simvastatin). It is important to review these carefully and consult your healthcare provider with any concerns or questions.

• Severe Muscle Pain and Damage: Vytorin may lead to muscle pain, tenderness, or weakness. In severe cases, it can cause muscle breakdown (rhabdomyolysis), which can be life-threatening. Contact your healthcare provider immediately if you experience fever, muscle pain, or weakness. Be cautious about starting new medications without consulting your provider, as some drugs may increase the risk of rhabdomyolysis. Those at higher risk include older adults, individuals taking 80 mg of simvastatin, those with kidney problems, people on other medications that affect muscles, and individuals with a history of uncontrolled hypothyroidism.

• Liver Problems: Vytorin may cause liver irritation, often detected only through blood tests. While liver enzyme levels usually normalize after stopping the medication, serious liver issues have been reported. Your healthcare provider might conduct liver function tests before and during treatment. Seek immediate medical attention if you notice symptoms such as nausea, abdominal pain, jaundice, or changes in stool color. Risk factors include a history of liver issues and consuming large amounts of alcohol.

• High Blood Sugar: Some individuals may experience increased blood sugar levels, potentially leading to elevated hemoglobin A1C levels. Inform your healthcare provider if you have a history of high blood sugar before starting Vytorin. Maintaining a healthy diet and regular exercise is advised. Regular monitoring of blood sugar levels may be necessary.

Contraindications: Avoid using Vytorin if any of the following conditions apply, as they may pose significant health risks:

• Concurrent use with specific medications, such as azole antifungals, macrolide antibiotics, certain antiviral drugs, nefazodone, cyclosporine, or gemfibrozil.
• Existing liver problems.
• Pregnancy and breastfeeding.

Adhering to these guidelines is critical for your safety while on Vytorin. Always follow your healthcare provider’s advice and report any unusual symptoms or concerns.

Common side effects:

• Headaches
• Muscle pain
• Runny nose
• Cough
• Diarrhea

Less common but important to monitor:

• Tiredness
• Pain in the arms, hands, legs, and feet
• Skin rashes or changes

Serious side effects:

• Rhabdomyolysis (muscle breakdown)
• Serious liver problems
• Allergic reaction

Certain medications can interact with this drug, potentially altering its effectiveness or increasing the risk of side effects. These include "blood thinners" like Warfarin, as well as Cyclosporine, Danazol, daptomycin, and Gemfibrozil. Additionally, drugs that impact the elimination of simvastatin from your body can affect how it works. These drugs include azole antifungals such as Itraconazole, Ketoconazole, Posaconazole, and Voriconazole, as well as cobicistat, Colchicine, macrolide antibiotics like Clarithromycin and Erythromycin, Nefazodone, HIV protease inhibitors (such as nelfinavir), Ritonavir, and telithromycin.

For patients of Chinese descent, it is advised not to take Niacin in doses of 1 gram or more when using this medication, as it can heighten the risk of side effects, especially muscle problems. Consult your healthcare provider for more information. Additionally, avoid using Red Yeast Rice products while on ezetimibe/simvastatin since they may contain Lovastatin, another statin, which could increase the risk of serious muscle and liver issues.