tolvaptan

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tolvaptan

Pronunciation:tol VAP tan
Brand:Samsca

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

donotYou should not use this medication if you are allergic to tolvaptan, if you are unable to urinate, if you are unable to tell that you are thirsty, or if you are severely dehydrated and feel like you might pass out.

You should not take tolvaptan if you are using certain other medications. Before you take tolvaptan, tell your doctor about all other medications you use. Your doctor will tell you if any of your medications need to be changed while taking tolvaptan.

Also tell your doctor if you have severe liver disease or cirrhosis, if you have been drinking large amounts of alcohol, or if you are malnourished.

emtYou will receive your first few doses of tolvaptan in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.
emtIf you stop taking tolvaptan for any length of time, do not start taking it again at home. You will need to be in a hospital under observation any time you start or restart treatment with tolvaptan.

Tell your 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, mood changes, and seizure (convulsions).

waterDrink plenty of fluids during the first 24 hours of treatment with tolvaptan. Avoid alcoholic drinks. Follow your doctor's instructions about the type and amount of liquids you should drink while treating hyponatremia. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with tolvaptan.

What is tolvaptan?

Tolvaptan reduces the level of a hormone that regulates the balance of water and salt (sodium) in the body. High levels of this hormone can cause an imbalance that results in low sodium levels and fluid retention.

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

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

What should I discuss with my health care provider before taking tolvaptan?

donotYou should not use this medication if you are allergic to tolvaptan, if you are unable to urinate, if you are unable to tell that you are thirsty, or if you are severely dehydrated and feel like you might pass out.

You should not take tolvaptan if you are taking any of the following medications:

  • conivaptan (Vaprisol);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
  • antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • an antidepressant such as nefazodone;
  • heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or
  • HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

Your doctor will tell you if any of your medications need to be changed while taking tolvaptan.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take tolvaptan:

  • severe liver disease (especially cirrhosis);
  • if you are malnourished; or
  • if you have been drinking large amounts of alcohol.
nopregFDA pregnancy category C. It is not known whether tolvaptan is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
nobrfeedIt is not known whether tolvaptan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take tolvaptan?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

emtYou will receive your first few doses of tolvaptan in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Tolvaptan is usually given once per day, with or without food.

waterTake this medication with a full glass (8 ounces) of water. Drink plenty of fluids during the first 24 hours of treatment with tolvaptan. It is best to drink something as soon as you feel thirsty, but avoid alcoholic drinks. Follow your doctor's instructions about the type and amount of liquids you should drink while treating hyponatremia. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
emtCall your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to serious side effects.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with tolvaptan.

emtIf you stop taking tolvaptan for any length of time, do not start taking it again at home. You will need to be in a hospital under observation any time you start or restart treatment with tolvaptan.
rtStore tolvaptan at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

emtSeek emergency medical attention if you think you have used too much of this medicine. Overdose can cause dehydration (weakness, extreme thirst, increased urination, decreased sweating, hot or dry skin).

What should I avoid while taking tolvaptan?

Grapefruit and grapefruit juice may interact with tolvaptan and lead to potentially dangerous effects. Avoid drinking grapefruit juice while taking tolvaptan.

What are the possible side effects of tolvaptan?

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

Tell your 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, mood changes, and seizure (convulsions).

donotStop using tolvaptan and call your doctor at once if you have a serious side effect such as:
  • weakness or fainting;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;

Less serious side effects may include:

  • dry mouth;
  • increased thirst or urination;
  • constipation; or
  • loss of appetite, fruity breath odor, drowsiness, dry skin, nausea, vomiting.

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?

Many drugs can interact with tolvaptan. Below is just a partial list. Tell your doctor if you are using:

  • aprepitant (Emend);
  • birth control pills;
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (digitalis, Lanoxin);
  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
  • St. John's wort;
  • an antibiotic such as doxycycline (Adoxa, Doryx, Oracea, Vibramycin), metronidazole (Flagyl), norfloxacin (Noroxin), tetracycline (Ala-Tet, Brodspec, Sumycin),
  • an antidepressant such as desipramine (Norpramin) or sertraline (Zoloft);
  • a barbiturate such as phenobarbital (Solfoton) and others;
  • a diuretic (water pill) such as amiloride (Midamor), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide);
  • heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others;
  • HIV or AIDS medicine such as efavirenz (Sustiva), etravirine (Intelence), nevirapine (Viramune), and others;
  • potassium supplements, potassium citrate (K-Lyte, Urocit-K, Citrolith, Polycitra), and others; or
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.
donotThis list is not complete and there are many other medicines that can interact with tolvaptan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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.

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