Sodium phenylbutyrate

Generic Name: sodium phenylbutyrate (SOE-dee-um fen-il-BYOO-ti-rate)
Brand Name: Buphenyl

Sodium phenylbutyrate is used for:

Treating urea cycle (nitrogen or ammonia excretion) disorders along with a prescribed diet.

Sodium phenylbutyrate is a nutritional modifier. It works by helping rid the body of excess nitrogen waste by bypassing the urea cycle.

Do NOT use sodium phenylbutyrate if:

  • you are allergic to any ingredient in sodium phenylbutyrate
  • you have sudden high levels of ammonia in the blood

Contact your doctor or health care provider right away if any of these apply to you.

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Before using sodium phenylbutyrate:

Some medical conditions may interact with sodium phenylbutyrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have edema (swelling or water retention), heart failure or other heart problems, high blood pressure, or kidney or liver disease

Some MEDICINES MAY INTERACT with sodium phenylbutyrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone), haloperidol, or valproic acid because these medicines increase blood ammonia levels
  • Probenecid because the actions and side effects of sodium phenylbutyrate may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if sodium phenylbutyrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use sodium phenylbutyrate:

Use sodium phenylbutyrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take sodium phenylbutyrate with meals.
  • It is very important that your full dose for a 24-hour period is taken. The total daily dose should be taken in equally divided amounts (3 to 6 times per day).
  • It is very important to follow the prescribed diet given to you by your doctor.
  • Sodium phenylbutyrate comes with an additional patient information sheet. Read it carefully and reread it each time you get sodium phenylbutyrate refilled.
  • If you miss a dose of sodium phenylbutyrate, take it as soon as possible that same day.

Ask your health care provider any questions you may have about how to use sodium phenylbutyrate.

Important safety information:

  • Wear a MedicAlert tag that states that you have a urea cycle disorder.
  • LAB TESTS, such as blood tests for ammonia and amino acid levels, will be required to monitor your progress. Be sure to keep all doctor and lab appointments.
  • Sodium phenylbutyrate is not recommended for use in CHILDREN weighing less than 44 pounds (20 kg). Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if sodium phenylbutyrate causes harm to the developing fetus. If you become pregnant, discuss with your doctor the benefits and risks of using sodium phenylbutyrate during pregnancy. It is unknown if sodium phenylbutyrate is excreted in breast milk. If you are or will be breast-feeding while taking sodium phenylbutyrate, consult your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of sodium phenylbutyrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste in mouth; body odor; decreased appetite; absent or irregular menstrual periods.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; disorientation; headache; lightheadedness; memory problems; sleepiness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of sodium phenylbutyrate:

Store sodium phenylbutyrate between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. After opening, keep the bottle tightly closed. Do not store in the bathroom. Keep sodium phenylbutyrate out of the reach of children and away from pets.

General information:

  • If you have any questions about sodium phenylbutyrate, please talk with your doctor, pharmacist, or other health care provider.
  • Sodium phenylbutyrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sodium phenylbutyrate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sodium phenylbutyrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sodium phenylbutyrate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sodium phenylbutyrate.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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