Samsca Warnings and Precautions

There are certain precautions to take when using Samsca, such as following warnings about potential drug interactions and avoiding it if you have certain allergies. Discussing your medical history with your healthcare provider can help minimize your risk for potentially serious complications with this prescription medication.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Samsca® (tolvaptan) 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 Precautions and Warnings for Samsca

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 Samsca. If you have cirrhosis, your healthcare provider will weigh the benefits of Samsca 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 Samsca 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 Samsca, hypertonic saline may increase the risk that your blood sodium levels will increase too quickly. Therefore, if you need IV fluids during Samsca treatment, your healthcare provider will give you a sodium solution with less salt, such as a normal saline solution.
  • Samsca 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 Samsca 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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Samsca Medication Information

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