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This document provides essential safety and warning information concerning the use of ketoconazole tablets. Please read carefully and discuss any concerns with your healthcare provider.

• Not for Certain Infections: Ketoconazole tablets are not suitable for treating nail or skin fungal infections or any use not approved by the FDA. Due to the risk of severe side effects, including liver damage and heart issues, this medication is reserved for serious, systemic fungal infections when no safer alternatives are available.

• Liver Damage: There is a significant risk of liver damage while taking ketoconazole tablets, with some cases requiring liver transplantation. Blood tests will be conducted before and during treatment to monitor liver function. Seek immediate medical help if you experience symptoms such as yellowing of the skin or eyes, changes in stool color, dark urine, abdominal swelling, stomach pain, or confusion. Alcohol consumption and concurrent use of other liver-impacting medications increase this risk.

• Heart Rhythm Concerns: The medication may cause potentially fatal heart rhythm issues, such as QT prolongation. Your risk heightens with factors like abnormal electrolyte levels, existing heart rhythm disorders, or concurrent use of other QT-prolonging drugs (e.g., amiodarone, ciprofloxacin). Regular monitoring through electrocardiograms (EKGs) may be conducted. If symptoms like chest pain, palpitations, difficulty breathing, faintness, or lightheadedness occur, contact emergency services immediately.

• Adrenal Insufficiency: Ketoconazole tablets can reduce cortisol levels, leading to adrenal insufficiency. Symptoms include weakness, fatigue, dizziness, appetite loss, and mood changes. Notify your provider if these symptoms emerge to evaluate the continuation of treatment.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, are possible. If you experience breathing difficulties, facial swelling, rapid heartbeat, dizziness, or a choking sensation, seek medical attention immediately.

• Drug Interactions: Ketoconazole tablets can interact with many medications, including over-the-counter drugs, vitamins, and supplements, potentially leading to dangerous effects. Inform your healthcare provider and pharmacist about all substances you are taking. Notable interactions include medications like alprazolam and statins such as simvastatin and lovastatin.

Contraindications: Ketoconazole tablets should not be used if you have severe liver issues or are taking certain interacting medications. Consult your healthcare provider if these conditions apply to you.

Ketoconazole, commonly known by its brand name Nizoral, is an antifungal medication that can interact with various other drugs, potentially leading to serious health risks. These interactions primarily occur because ketoconazole inhibits the enzyme CYP3A4, which is responsible for metabolizing many medications. As a result, co-administering ketoconazole with certain drugs can increase their levels in the bloodstream, heightening the risk of adverse effects.

Medications to Avoid with Ketoconazole:

The following drugs should not be taken with ketoconazole due to the risk of severe interactions:

• Certain Sedatives and Anxiolytics: Alprazolam, Midazolam, and Triazolam.
• Cholesterol-Lowering Agents: Lovastatin and Simvastatin.
• Medications for Irregular Heartbeats: Dofetilide and quinidine.
• Ergot Alkaloids: Ergotamine and Dihydroergotamine.
• Certain Blood Pressure Medications: Eplerenone and nisoldipine.
• Gastrointestinal Motility Agents: Cisapride.
• Antipsychotic Medications: Pimozide.

Combining ketoconazole with these medications can lead to serious conditions such as heart rhythm abnormalities, muscle breakdown, and excessive sedation.

Medications Requiring Caution:

Other drugs may require careful monitoring or dosage adjustments when used with ketoconazole:

• Opioid Pain Relievers: Hydrocodone and Oxycodone.
• Certain Antidepressants: Amitriptyline.
• Calcium Channel Blockers: Amlodipine and felodipine.
• Immunosuppressants: Cyclosporine and Tacrolimus.
• Anticoagulants: Warfarin.

Using ketoconazole with these medications can increase their effects, potentially leading to side effects like respiratory depression, low blood pressure, or bleeding complications.

Impact of Stomach Acid on Ketoconazole Absorption:

Ketoconazole requires stomach acid for proper absorption. Medications that reduce stomach acid, such as antacids, H2 blockers (like ranitidine), and proton pump inhibitors (like Omeprazole), can decrease the effectiveness of ketoconazole. To minimize this interaction, it's recommended to take ketoconazole at least two hours before or after these acid-reducing agents.

Alcohol Interaction:

Consuming alcohol while taking ketoconazole can lead to a disulfiram-like reaction, characterized by flushing, rash, nausea, and headache. It's advisable to avoid alcohol during and for at least 48 hours after completing ketoconazole therapy.

Recommendations:

Before starting ketoconazole, inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are currently taking. This will help prevent potential interactions and ensure the safe and effective use of ketoconazole.