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Tolvaptan

Generic Name: Tolvaptan (tol VAP tan)
Brand Name: Samsca

  • Start and restart tolvaptan in a hospital setting where your sodium levels will be closely watched. Very bad and sometimes deadly effects may happen from fixing low sodium levels too fast. The chance is raised in people with poor nutrition, very bad liver disease, or alcohol addiction. Call your doctor right away if you have signs like trouble speaking or swallowing, feeling sleepy, confusion, mood changes, trouble controlling body movements, muscle weakness, and seizures.

Uses of Tolvaptan:

  • It is used to treat low sodium levels.

What do I need to tell my doctor BEFORE I take Tolvaptan?

  • If you have an allergy to tolvaptan or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you cannot tell when you are thirsty or you are not able to drink normally.
  • If you have a low sodium level that needs raised right away. Talk with your doctor.
  • If you are dehydrated, talk with your doctor.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you are not able to pass urine.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with tolvaptan, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this medicine. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with tolvaptan.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tolvaptan with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tolvaptan?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take tolvaptan for longer than you were told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Avoid grapefruit and grapefruit juice.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • If loose stools (diarrhea) happen or you are throwing up, call your doctor. You will need to drink more fluids to keep from losing too much fluid.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tolvaptan while you are pregnant.

How is this medicine (Tolvaptan) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking tolvaptan as you have been told by your doctor or other health care provider, even if you feel well.
  • Follow what doctor says for drinking liquids.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you miss taking this medicine for a few days in a row, call your doctor before you start taking it again.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Fever.
  • Very bad belly pain.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Very bad and sometimes deadly liver problems have happened with tolvaptan. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Tolvaptan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • More thirst.
  • Feeling tired or weak.
  • Hard stools (constipation).
  • Dry mouth.
  • Passing urine more often.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tolvaptan?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about tolvaptan, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tolvaptan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using tolvaptan.

Review Date: November 1, 2017

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