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The following safety information outlines important risks and precautions related to the use of Zetia (ezetimibe). Please read carefully and consult your healthcare provider if you have any questions or concerns.

• Severe Muscle Pain and Damage: Zetia (ezetimibe), particularly when used in combination with statins, may lead to a serious muscle disorder called rhabdomyolysis. This condition involves the breakdown of muscle tissue and can result in significant kidney complications. If you experience symptoms such as intense muscle pain, dark urine, weakness, or fatigue, discontinue Zetia (ezetimibe) immediately and seek medical assistance. Individuals at higher risk include those over 65, those with kidney issues, those taking Zetia with statins, and those with uncontrolled hypothyroidism.

• Liver Problems with Statins: Combining Zetia (ezetimibe) with a statin can lead to liver damage. Regular blood tests are required before and during treatment to monitor liver function. Most liver issues resolve after discontinuing the medication. Seek medical attention if you notice signs of liver trouble, such as jaundice, nausea, vomiting, or dark urine. You may need to stop taking Zetia (ezetimibe) to prevent further liver damage. Patients with a history of liver problems or those using statins with Zetia are at increased risk.

Please adhere to these guidelines to ensure safe usage of Zetia (ezetimibe).

When taking Zetia (ezetimibe), it's important to be aware of potential interactions with other medications, as these can affect how Zetia works or increase the risk of side effects. Here are some key interactions to consider:

Cyclosporine: Combining Zetia with cyclosporine, a medication used to suppress the immune system, can lead to increased levels of both drugs in the bloodstream. This elevation may heighten the risk of side effects from each medication. If you're prescribed both, your doctor will monitor your cyclosporine levels closely to ensure safety.

Fibrates: Fibrates are a class of drugs used to lower cholesterol and triglyceride levels. While Zetia can be used with Fenofibrate, combining it with other fibrates is not recommended. This combination may increase cholesterol excretion into the bile, potentially leading to gallstones. If you're taking Zetia and experience symptoms like sudden abdominal pain, nausea, or vomiting, contact your healthcare provider promptly.

Bile Acid Sequestrants: Medications such as Cholestyramine, Colesevelam, and Colestipol are used to lower cholesterol by binding bile acids in the intestine. Taking Zetia simultaneously with these drugs can reduce Zetia's effectiveness. To avoid this interaction, it's advised to take Zetia at least 2 hours before or 4 hours after taking a bile acid sequestrant.

Warfarin: Warfarin is a blood thinner used to prevent blood clots. When taken with Zetia, there may be an increased risk of bleeding. If you're on both medications, your doctor will likely monitor your blood clotting parameters more closely to ensure they remain within a safe range.

Alcohol: While there are no direct interactions between Zetia and alcohol, excessive alcohol consumption can strain the liver. Since both alcohol and Zetia can affect liver function, it's advisable to limit alcohol intake during treatment. Discuss your alcohol consumption with your doctor to determine what's safe for you.

Always inform your healthcare provider about all medications, supplements, and herbal products you're taking. This information helps them manage potential interactions and ensure your treatment is both safe and effective.