Tolvaptan may cause the level of sodium in your blood to increase too quickly. This may cause osmotic demyelination syndrome (ODS; serious nerve damage that may be caused by quick increases in sodium levels). Tell your doctor if you drink or have ever drunk large amounts of alcohol, if you have malnutrition (the body lacks the nutrients needed for good health), and if you have or have ever had liver disease or extremely low levels of sodium in your blood.
You and your doctor will take certain precautions to try to prevent ODS. You will begin your treatment with tolvaptan in the hospital so that your doctor can monitor you closely. If your doctor tells you to continue taking tolvaptan after you leave the hospital, you should not stop and re-start treatment on your own. You will need to return to the hospital when you restart the medication.
You will need to drink water whenever you are thirsty to help prevent ODS during your treatment with tolvaptan. Your doctor will not prescribe tolvaptan if you are unable to feel that you are thirsty. You should have drinking water available at all times during your treatment.
If you experience any of the following symptoms of ODS, tell your doctor immediately: difficulty speaking, difficulty swallowing, feeling that food or drinks are getting stuck in your throat, drowsiness, confusion, mood changes, body movements that are difficult to control, weakness of the arms or legs, or seizures.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tolvaptan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risk of taking tolvaptan.
Tolvaptan is used to increase low levels of sodium in the blood in people who have heart or liver disease or certain other conditions. Tolvaptan is in a class of medications called vasopressin V2receptor antagonists. It works by increasing the amount of water released from the body as urine. Removing fluid from the body helps to increase the level of sodium in the blood.
Tolvaptan comes as a tablet to take by mouth. It is usually taken once a day with or without food. At the beginning of your treatment, you will be given tolvaptan at a regularly scheduled time in the hospital. If you are told to take tolvaptan at home after you are discharged, you should take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tolvaptan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of tolvaptan and gradually increase your dose, not more often than once every 24 hours.
Talk to your doctor about what you should do after you stop taking tolvaptan. You will probably need to limit the amount of fluid you drink, and your doctor will monitor you carefully during this time.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking tolvaptan,
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Tolvaptan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
Tolvaptan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to tolvaptan.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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