TOLVAPTAN

(tol VAP tan) Brand: Samsca

What is the most significant information I must know about tolvaptan?

• You must not use this medication if you have cirrhosis or another liver malady, if you are unable to urinate, if you are unable to speak that you are thirsty, or if you are severely dehydrated and feel like you might pass out. Also speak your doctor if you have if you have been drinking big amounts of alcohol, or if you are malnourished.

• You will receive your first little doses of tolvaptan in a hospital setting where your heart rhythm can be monitored, in case the medicine causes serious side effects.

• Speak 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).

• If you stop taking tolvaptan for any length of time, do not start taking it again at house. You will need to be in a hospital under observation any time you start or restart treatment with tolvaptan.

What is tolvaptan?

• Tolvaptan reduces the level of a hormone that regulates the balance of water and salt (sodium) in the body. Tall levels of this hormone can reason 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, and determined hormonal imbalances. Tolvaptan improves urine flow without causing the body to lose too many sodium as you urinate.

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

What must I discuss with my health care provider till taking tolvaptan?

• You must not use this medication if you are allergic to tolvaptan, or if you have:

· cirrhosis or another liver disease;

· if you are unable to urinate;

· if you are unable to speak that you are thirsty; or

· if you are severely dehydrated and feel like you might pass out.

• Many drugs can interact with tolvaptan and some must not be used at the same time. Speak your doctor about all another medications you use, especially:

· nefazodone;

· an antibiotic--clarithromycin, telithromycin;

· antifungal medication--itraconazole, ketoconazole, voriconazole;

· hepatitis C medications--boceprevir, telaprevir; or

· HIV/AIDS medication--atazanavir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

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

• To create certain tolvaptan is safety for you, speak your doctor about your another medical conditions, especially:

· a history of alcoholism or liver disease;

· kidney disease;

· if you are malnourished; or

· if you have been drinking big amounts of alcohol.

• FDA pregnancy category C. It is not known whether tolvaptan will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• It is not known whether tolvaptan passes into breast milk or if it could harm a nursing child. You must not breast-feed while you are using tolvaptan.

How must I take tolvaptan?

• Tolvaptan is generally given once for day. Follow all directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results. Do not take this medication in larger or less amounts or for longer than recommended. Long-term use of tolvaptan can hurt your liver or reason death. You must not use tolvaptan for longer than 30 days

• You will receive your first little doses of tolvaptan in a hospital setting where your heart rhythm can be monitored, in case the medicine causes serious side effects.

• You may take tolvaptan with or without food.

• Take 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 excellent 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 must drink while treating hyponatremia. In some cases, drinking too many liquid can be as unsafe as not drinking enough.

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

• To be certain tolvaptan is helping your condition, you may need frequent blood trials.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking tolvaptan?

• Avoid alcoholic drinks.

• Grapefruit and grapefruit juice may interact with tolvaptan and lead to unwanted side effects. Discuss the use of grapefruit commodity with your doctor.

What are the possible side effects of tolvaptan?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Speak 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).

• Stop using tolvaptan and call your doctor at once if you have:

· weakness or fainting;

· black, bloody, or tarry stools;

· coughing up blood or vomit that looks like coffee grounds;

· liver symptoms--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

· dehydration (feeling very thirsty or hot, being unable to urinate, hard sweating, or hot and dry skin).

• General side effects may include:

· dry mouth;

· heighten 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect tolvaptan?

• Much drugs can interact with tolvaptan. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with tolvaptan, especially:

· cyclosporine;

· St. John's wort;

· seizure medication--carbamazepine, phenobarbital, phenytoin; or

· tuberculosis medication--rifabutin, rifampin, rifapentine.

• This list is not complete and much another drugs can interact with tolvaptan. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about tolvaptan.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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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