TOLVAPTAN - ORAL
Common Brand Name(s): Samsca
Phonetic Pronunciation: (tol-VAP-tan)
Information last revised May 2010
What does TOLVAPTAN - ORAL look like?
Samsca 15 mg Tab
Samsca 30 mg Tab
Uses:
This medication is used to treat low levels of salt (sodium) in the blood, which can result from conditions such as heart failure, liver disease, and certain hormone imbalances. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by increasing the amount of urine you make, causing your body to get rid of extra water. This helps to slowly increase to normal levels of salt (sodium) in the blood.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
How To Use
Read the Medication Guide provided by your pharmacist before you start using tolvaptan and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with or without food, usually once daily or as directed by your doctor. To prevent losing too much body water (dehydration), have water available to drink at all times while taking tolvaptan. Drink when you are thirsty unless otherwise directed by your doctor. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details. Dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop and restart this medication on your own. You may need to go back to a hospital to restart this medication. Tell your doctor immediately if you stop taking this medication for any reason.
Drug Interactions
See also How to Use section. The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Other medications can affect the removal of tolvaptan from your body, which may affect how tolvaptan works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's Wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
Notes
Do not share this medication with others. Laboratory and/or medical tests (such as levels of sodium/potassium in the blood) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
Precautions
Before taking tolvaptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, kidney disease, liver disease, use/abuse of alcohol. To prevent loss of too much body water (dehydration) while taking this medication, you must be able to replace fluids by drinking. Before taking this medication, tell your doctor if you are not able to drink normally or if you cannot feel if you are thirsty. (See also How to Use section.) This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. If you have diabetes, be sure to check your blood sugar regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Storage
Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your medication.
Side Effects
See also Warning section. Thirst, dry mouth, loss of appetite, constipation, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Loss of too much body water (dehydration) can occur. The risk is increased if you have persistent vomiting or diarrhea, and cannot drink normally. Contact your doctor immediately if you notice any symptoms of dehydration, such as fast heartbeat or dizziness/lightheadedness. People with severe liver disease (cirrhosis) may have increased risk of bleeding from the stomach or intestines while taking this medication. Tell your doctor immediately if you have any of the following symptoms: black/bloody stools, vomit that contains blood or looks like coffee grounds. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Warning
Treatment with this drug should be started or restarted in a hospital for proper monitoring. Too rapid correction of low levels of sodium in the blood may rarely result in a serious (rarely fatal) condition - osmotic demyelination syndrome (ODS). Tell your doctor immediately if you notice any of the following symptoms of ODS: trouble speaking/swallowing, mental/mood changes (such as confusion), weakness/involuntary movement in the arms/legs, or seizures.
This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
The information contained in the First DataBank databases is intended to supplement the knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy problems and patient counselling information. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services. First DataBank disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose.
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