Samsca

DRUG DESCRIPTION

Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-otolu-m-toluidide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.94. The chemical structure is:

SAMSCAź (tolvaptan) Structural Formula Illustration

SAMSCA tablets for oral use contain 15 mg or 30 mg of tolvaptan. Inactive ingredients include corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose and FD&C Blue No. 2 Aluminum Lake as colorant.

What are the possible side effects of tolvaptan (Samsca)?

Get 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).

Stop using tolvaptan and call your doctor at once if you have a serious side effect such as:

  • weakness or...

Read All Potential Side Effects and See Pictures of Samsca »

What are the precautions when taking tolvaptan tablets (Samsca)?

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...

Read All Potential Precautions of Samsca »


Samsca Consumer (continued)

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.

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.


Samsca Patient Information Including Side Effects

Brand Names: Samsca

Generic Name: tolvaptan (Pronunciation: tol VAP tan)

  • What is tolvaptan (Samsca)?
  • What are the possible side effects of tolvaptan (Samsca)?
  • What is the most important information I should know about tolvaptan (Samsca)?
  • What should I discuss with my health care provider before taking tolvaptan (Samsca)?
  • How should I take tolvaptan (Samsca)?
  • What happens if I miss a dose (Samsca)?
  • What happens if I overdose (Samsca)?
  • What should I avoid while taking tolvaptan (Samsca)?
  • What other drugs will affect tolvaptan (Samsca)?
  • Where can I get more information?

What is tolvaptan (Samsca)?

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 are the possible side effects of tolvaptan (Samsca)?

Get 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).

Stop 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 is the most important information I should know about tolvaptan (Samsca)?

You 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.

You 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.

If 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).

Drink 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.

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