sodium phenylbutyrate and taurursodiol

What is the most important information I should know about sodium phenylbutyrate and taurursodiol?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is sodium phenylbutyrate and taurursodiol?

Sodium phenylbutyrate and taurursodiol is used to treat adults with amyotrophic lateral sclerosis (ALS).

Sodium phenylbutyrate and taurursodiol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sodium phenylbutyrate and taurursodiol?

Tell your doctor if you have ever had:

• liver or kidney disease;
• pancreas problems;
• intestinal problems; or
• heart failure (including congestive heart failure) or high blood pressure.

Tell your doctor if you are pregnant or breastfeeding.

How should I take sodium phenylbutyrate and taurursodiol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Sodium phenylbutyrate and taurursodiol should be taken before a snack or meal. Empty one packet of this medicine in a cup (8 ounces) with water (room temperature) and stir well.

Sodium phenylbutyrate and taurursodiol can be taken by mouth or through a feeding tube up to one hour after preparing it. Throw away any unused medicine after one hour.

Sodium phenylbutyrate and taurursodiol has a high salt (sodium) content. For people who are sensitive to salt intake (those with heart failure, high blood pressure, kidney problems, or other conditions related to sodium retention) the amount of salt ingested may need to be limited. Talk to your healthcare provider about the total amount of daily salt that is appropriate for you.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking sodium phenylbutyrate and taurursodiol?

Avoid taking antacids containing aluminum while you are using sodium phenylbutyrate and taurursodiol.

What are the possible side effects of sodium phenylbutyrate and taurursodiol?

• new or worsening diarrhea; or
• fluid retention --shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection).

Common side effects may include:

• diarrhea, stomach pain, nausea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 other drugs will affect sodium phenylbutyrate and taurursodiol?

Tell your doctor about all your other medicines, especially:

• taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).

This list is not complete. Other drugs may affect sodium phenylbutyrate and taurursodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about sodium phenylbutyrate and taurursodiol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every 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 outside 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 should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid 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.

Copyright 1996-2023 Cerner Multum, Inc. Version: 1.01. Revision date: 12/5/2022.