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.

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

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 sodium phenylbutyrate and taurursodiol 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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

Initial dose: 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) orally once daily for three weeks
Maintenance dose: 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) orally twice daily

Comment: Maintenance dose should be initiated after first 3 weeks of initial dose.

Use: Amyotrophic lateral sclerosis

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.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sodium phenylbutyrate and taurursodiol may cause serious side effects. Call your doctor at once if you have:

• 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 of sodium phenylbutyrate and taurursodiol 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.

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.