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Before beginning treatment with tolvaptan (Samsca), it's vital to understand the associated precautions and risks. This medication requires careful monitoring, especially when initiated or resumed, preferably in a hospital setting. Below are critical safety warnings and guidelines to consider:

• Rapid Sodium Correction Risks: Tolvaptan is used to increase blood sodium levels. However, elevating these levels too quickly can lead to osmotic demyelination syndrome (ODS), a severe and potentially fatal brain condition. This risk is heightened in individuals with liver disease, poor nutrition, alcohol use, SIADH, very low sodium levels, or those not consuming enough fluids. Be alert for symptoms like speech difficulties, paralysis, seizures, or confusion, and seek immediate medical attention if they occur.

• Liver Health Concerns: The use of tolvaptan can cause significant liver issues, potentially leading to liver failure. Treatment duration is typically capped at 30 days, with regular liver function monitoring through blood tests. Watch for signs like jaundice, fatigue, appetite loss, nausea, abdominal pain, vomiting, or dark urine. If these symptoms appear, contact your healthcare provider as you may need to discontinue the medication.

• Dehydration Risks: This medication increases urination, which can result in dehydration. It's crucial to maintain adequate hydration. Look for symptoms such as dry mouth, weight loss, rapid heartbeat, or dizziness—indicative of dehydration—and inform your provider. Blood tests will be conducted regularly to monitor sodium levels and fluid balance.

• Drug Interactions: Tolvaptan interacts with many medications and substances like grapefruit. Some medications, such as itraconazole and ritonavir, can elevate tolvaptan levels and increase side effects. Always inform your healthcare provider of all medications you're taking and avoid starting new ones without professional guidance.

• High Potassium Levels: The reduction in body water due to tolvaptan may lead to elevated potassium levels, especially if you're on medications like potassium-sparing diuretics or ACE inhibitors. Monitoring of potassium levels will be necessary.

• Urination Issues: If you have conditions affecting urination, such as benign prostatic hyperplasia or urinary blockages, tolvaptan might cause urine buildup in the bladder. Ensure your provider is aware of your medical history to prevent complications.

Contraindications:

• Individuals with autosomal dominant polycystic kidney disease (ADPKD) not under FDA-approved monitoring should not use tolvaptan.
• Tolvaptan is unsuitable for those who cannot sense thirst, have low sodium levels with low blood volume, take specific medications that elevate its blood levels, or cannot urinate due to obstructions.

In case of an overdose or severe symptoms, seek emergency medical attention immediately. Always consult your healthcare provider for personalized medical advice and to ensure safe use of tolvaptan (Samsca).

Common side effects:

• thirst
• dry mouth
• increased urination
• lack of energy
• constipation
• elevated blood sugar levels

Less common but important to monitor:

• fever
• reduced appetite

Serious side effects:

• osmotic demyelination syndrome
• liver problems
• dehydration symptoms
• high blood potassium levels
• gastrointestinal bleeding
• severe allergic reaction

Interactions with high risk of serious adverse effects and should be avoided:

• Boceprevir
• Conivaptan
• Telaprevir
• Desmopressin
• Clarithromycin
• Cobicistat
• Delavirdine
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telithromycin
• Tipranavir
• Voriconazole

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Amobarbital
• Amprenavir
• Aprepitant
• Atazanavir
• Butabarbital
• Capmatinib
• Carbamazepine
• Ceritinib
• Ciprofloxacin
• Crizotinib
• Cyclosporine
• Digoxin
• Diltiazem
• Dronedarone
• Duvelisib
• Efavirenz
• Enzalutamide
• Erythromycin
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Imatinib
• Ivosidenib
• Larotrectinib
• Lasmiditan
• Lefamulin
• Letermovir
• Lorlatinib
• Lumacaftor
• Mitotane
• Modafinil
• Netupitant
• Nevirapine
• Nilotinib
• Oxcarbazepine
• Pentobarbital
• Phenobarbital
• Phenytoin
• Pioglitazone
• Rifabutin
• Rifampin
• Rifapentine
• Secobarbital
• Simeprevir
• St John's Wort
• Venetoclax
• Verapamil