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Precautions and Warnings With Tolvaptan

By reviewing the safety precautions and warnings with tolvaptan, you can reduce your risk of drug interactions, allergic reactions, and other problems. Tolvaptan is not suitable for everyone; for example, people with kidney or liver problems may not be able to safely use it. It's also important to be aware of potentially dangerous side effects, such as vomiting or diarrhea, which require immediate medical care.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking tolvaptan (Samsca®) if you have:
  • An inability to tell if you are thirsty
  • An inability to make urine
  • Kidney disease, such as kidney failure
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Severe dehydration or malnutrition
  • Alcoholism or drink large amounts of alcohol
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Tolvaptan Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • If your blood sodium (salt) levels increase too quickly, you could develop a life-threatening condition known as osmotic demyelination syndrome (ODS). Therefore, you must start this medicine in the hospital, where your sodium levels can be monitored. Certain people may have a higher risk for ODS, including people who are malnourished and people who have very low blood sodium levels, alcoholism, or advanced liver disease.

    You can reduce your risk for ODS by drinking fluids when you are thirsty, unless your healthcare provider tells you otherwise. This is especially important during the first 24 hours of treatment. Also, let your healthcare provider know right away if you have symptoms of ODS, such as:
    • Trouble speaking, swallowing, or controlling your body movements
    • Extreme drowsiness
    • Confusion or mood changes
    • Muscle weakness in the arms and legs
    • Seizures.
  • There have been reports of stomach and intestinal (gastrointestinal or GI) bleeding occurring in people with cirrhosis (scarring of the liver due to liver disease) treated with tolvaptan. If you have cirrhosis, your healthcare provider will weigh the benefits of tolvaptan with the risks before recommending treatment.
  • This medication can cause you to lose too much body water and become dehydrated. It is important that you drink fluids if you feel thirsty during tolvaptan treatment, unless your healthcare provider tells you otherwise. Also, let your healthcare provider know if you have vomiting or diarrhea, especially if you cannot drink fluids normally, as this can cause dehydration.
  • Hypertonic saline is a sterile water solution that contains extra salt. It is sometimes used to treat extremely low blood sodium levels. When used with tolvaptan, hypertonic saline may increase the risk that your blood sodium levels will increase too quickly. Therefore, if you need IV fluids during tolvaptan treatment, your healthcare provider will give you a sodium solution with less salt, such as a normal saline solution.
  • Tolvaptan is a pregnancy Category C medication. This means it may not be safe for use during pregnancy, although the full risks are currently unknown (see Samsca and Pregnancy).
  • It is unknown if tolvaptan passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Samsca and Breastfeeding).
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Tolvaptan Drug Information

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