Tolvaptan Oral Tablets (Hyponatremia)

What is this medicine?

TOLVAPTAN (tol VAP tan) is a diuretic. It helps you make more urine and to lose excess water from your body. It treats low sodium levels in the blood.

How should I use this medicine?

Take this drug by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Do not take this drug with grapefruit juice.

Talk to your health care provider about the use of this drug in children. Special care may be needed.

Talk to your pediatrician regarding the use of this drug in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• black or tarry stools

• chest pain

• confusion

• fast, irregular heartbeat

• mood changes

• seizures

• trouble speaking

• uncontrollable body movements

• unusually weak or tired

• vomiting blood

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dry mouth

• increased hunger or thirst

• increased urination

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• ceritinib

• certain antibiotics like chloramphenicol, clarithromycin, dalfopristin; quinupristin, telithromycin

• certain antiviral medicines for HIV or AIDS like atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir

• certain medicines for fungal infection like ketoconazole, itraconazole, posaconazole, voriconazole

• conivaptan

• grazoprevir

• idelalisib

• mifepristone

• nefazodone

• ribociclib

• tucatinib

This medicine may also interact with the following medications:

• aprepitant

• certain antibiotics like erythromycin, rifampin, rifabutin, and rifapentine

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• cyclosporine

• desmopressin

• digoxin

• diuretics

• fluconazole

• grapefruit juice

• hypertonic saline

• St. John's Wort

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused drug after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cannot feel if you are thirsty

• dehydration

• history of alcohol abuse problem

• kidney disease

• liver disease

• malnutrition

• an unusual or allergic reaction to tolvaptan, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Check with your health care provider if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this drug.

You may need blood work done while you are taking this drug.