Sodium phenylbutyrate and taurursodiol

Sodium phenylbutyrate and taurursodiol

Sodium phenylbutyrate and taurursodiol

What is Sodium Phenylbutyrate and Taurursodiol?

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

Side effects of sodium phenylbutyrate and taurursodiol

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Sodium phenylbutyrate and taurursodiol can cause serious side effects. Call your doctor immediately if you have:

• new or worsening diarrhea; or

• Fluid retention – shortness of breath (even when lying down), swelling, rapid weight gain (especially in the face and middle of the body).

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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

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

Before you take this medicine

Tell your doctor if you have ever had:

• liver or kidney disease;

• problems with the pancreas;

• intestinal problems; or

• Heart failure (including 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 instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Sodium phenylbutyrate and taurursodiol should be taken before a snack or meal. Add one packet of sodium phenylbutyrate and taurursodiol to one cup (8 ounces) of water (room temperature) and stir well.

Sodium phenylbutyrate and taurursodiol can be taken orally or through a feeding tube up to one hour after preparation. Discard any unused medicine after one hour.

Sodium phenylbutyrate and taurursodiol have a high salt (sodium) content. People who are sensitive to salt intake (those with heart failure, high blood pressure, kidney problems, or other conditions related to sodium retention) may need to limit the amount of salt consumed. Talk to your doctor about the total amount of daily salt that is right for you.

Store at room temperature, protected from moisture and heat.

Sodium phenylbutyrate and taurursodiol dosage information

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

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

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

Use: Amyotrophic lateral sclerosis

What happens if I miss a dose?

Skip the missed dose and take the next dose at the regular time. Do not use two doses at the same time.

What happens if I overdose?

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

What should I avoid when taking sodium phenylbutyrate and taurursodiol?

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

What other drugs will affect sodium phenylbutyrate and taurursodiol?

Tell your doctor about all other medicines you are taking, especially:

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

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

More information

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