sodium phenylbutyrate

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

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

What is sodium phenylbutyrate?

Sodium phenylbutyrate is used in adults and children to treat urea cycle disorders.

Sodium phenylbutyrate can be used with other medicines and may also include changes in diet.

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

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

Sodium phenylbutyrate should not be used to treat immediate symptoms of an ammonia build-up.

Tell your doctor if you have:

• heart problems;
• high blood pressure;
• diabetes or a history of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency (sodium phenylbutyrate oral pellet contains sucrose); or
• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take sodium phenylbutyrate?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Wear a medical alert tag or carry an ID card to let others know you have a urea cycle disorder.

Doses are based on weight. Your dose may change if you gain or lose weight.

Measure the dose of sodium phenylbutyrate oral pellets with the supplied measuring device (not a kitchen spoon).

Swallow sodium phenylbutyrate oral pellets immediately with soft food, such as applesauce, or water, fruit juices, or protein-free infant formulas. Do not chew or mix into liquids.

Do not give or take sodium phenylbutyrate oral suspension and oral pellets through a gastrostomy or nasogastric tube

Your blood may need to be tested often.

What happens if I miss a dose?

Oral pellet: Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 3 hours. Do not use two doses at one time.

Oral suspension, tablets, powder: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking sodium phenylbutyrate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of sodium phenylbutyrate?

• nervous system problems-- sleepiness, tiredness, feeling light-headed, vomiting, nausea, headache, confusion;
• low blood potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• heart problems --swelling, rapid weight gain, feeling short of breath; or
• signs of infection --fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common side effects may include:

• missed menstrual periods or changes in your menstrual periods;
• loss of appetite;
• change in body odor; or
• unusual or unpleasant taste in your mouth.

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?

Tell your doctor about all your other medicines, especially:

• steroids;
• haloperidol;
• valproic acid; or
• probenecid.

This list is not complete. Other drugs may affect sodium phenylbutyrate, 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.

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: 5.01. Revision date: 7/21/2023.