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tolvaptan

Pronunciation: tol VAP tan

Brand: Jynarque, Samsca

Samsca

slide 1 of 2, Samsca,

15 mg, triangular, blue, imprinted with OTSUKA 15

Image of Samsca
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Tolvaptan

slide 2 of 2, Tolvaptan,

15 mg, triangular, blue, imprinted with OTSUKA 15

Image of Tolvaptan
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What is the most important information I should know about tolvaptan?

You will need frequent medical tests before and during treatment with tolvaptan.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

You should not use tolvaptan if you are dehydrated or unable to urinate, or if you can't tell when you are thirsty.

You also should not use Jynarque if you have ever had liver problems (other than polycystic liver disease), or if your sodium blood level is too high or too low.

Samsca is given to treat low levels of sodium in your blood, but can be dangerous if this condition is reversed too quickly. Tell your caregivers at once if you have problems with speech or muscle control, trouble swallowing, trouble moving your arms and legs, confusion, or seizure.

Tolvaptan can cause serious or fatal liver problems. Call your doctor right away if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

What is tolvaptan?

Jynarque is used to slow the decline in kidney function in adults who have autosomal dominant polycystic kidney disease.

Samsca is used to treat hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances. Samsca improves urine flow without causing the body to lose too much sodium as you urinate.

Tolvaptan may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking tolvaptan?

You should not use tolvaptan if you are allergic to it, or if:

  • you are unable to urinate;
  • you are unable to tell that you are thirsty; or
  • you are severely dehydrated and feel like you might pass out.

Samsca is not for use in people with autosomal dominant polycystic kidney disease (unless you receive Samsca through a special program that includes frequent liver function tests).

You should not take Samsca if your sodium level needs to be increased quickly.

You should not take Jynarque if you've been told that your sodium blood level is too high or too low.

Some medicines can cause unwanted or dangerous effects when used with tolvaptan. Your doctor may change your treatment plan if you also use:

  • nefazodone;
  • an antibiotic --clarithromycin, telithromycin;
  • antifungal medicine --itraconazole, ketoconazole; or
  • HIV/AIDS medication --indinavir, nelfinavir, ritonavir, saquinavir.

Tell your doctor if you have ever had:

  • kidney disease or urination problems;
  • liver problems;
  • allergies;
  • if you drink large amounts of alcohol;
  • if you are malnourished; or
  • if you also use desmopressin (dDAVP), or a diuretic or "water pill."

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breastfeed while using tolvaptan.

How should I take tolvaptan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Drink plenty of fluids while taking tolvaptan, but do not drink grapefruit juice or alcoholic drinks.

You may take tolvaptan with or without food.

Samsca is usually taken once per day and Jynarque is taken twice per day. Follow your doctor's dosing instructions very carefully.

You will need to be under observation in a hospital any time you start or restart treatment with Samsca, to quickly treat any serious side effects. If you stop taking Samsca for any length of time, do not start taking it again at home.

Long-term use of Samsca can damage your liver. You should not use Samsca for longer than 30 days.

You can easily become dehydrated while taking tolvaptan, which can lead to serious side effects. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Samsca: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

Jynarque: Skip the missed dose and use your next dose at the regular time.

Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tolvaptan?

Avoid alcoholic drinks.

Grapefruit may interact with tolvaptan and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of tolvaptan?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • weakness, confusion, or a light-headed feeling (like you might pass out);
  • irregular heartbeats;
  • unexplained weight loss;
  • dehydration symptoms --feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
  • liver problems --right-sided upper stomach pain, vomiting, loss of appetite, fever, itching, yellowing of your skin or eyes, not feeling well.

Samsca is given to treat low levels of sodium in your blood, but can be dangerous if your sodium level rises too fast. Tell your doctor or caregivers at once if you have any of these signs that your hyponatremia is being reversed too quickly:

  • problems with speech or muscle control;
  • trouble swallowing;
  • trouble moving your arms and legs;
  • confusion, mood changes; or
  • a seizure.

Common side effects may include:

  • dry mouth;
  • increased thirst or urination;
  • hunger, fruity breath odor;
  • constipation; or
  • weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tolvaptan?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect tolvaptan, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about tolvaptan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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