Glycerol phenylbutyrate

Generic Name: glycerol phenylbutyrate (GLIS-er-ol FEN-il-BUE-ti-rate)
Brand Name: Ravicti

Glycerol phenylbutyrate is used for:

Long-term management of urea cycle disorders. It may also be used for other conditions as determined by your doctor.

Glycerol phenylbutyrate is a nitrogen-binding agent. It works by increasing the removal of ammonia from the body.

Do NOT use glycerol phenylbutyrate if:

  • you are allergic to any ingredient in glycerol phenylbutyrate or to sodium phenylbutyrate
  • the patient is a child younger than 2 months old

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

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Before using glycerol phenylbutyrate:

Some medical conditions may interact with glycerol 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 a history of nerve or nervous system problems
  • if you have liver or kidney problems, pancreas problems, or bowel problems (eg, problems absorbing food)

Some MEDICINES MAY INTERACT with glycerol 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 blood ammonia levels may be increased
  • Probenecid because it may increase the risk of glycerol phenylbutyrate's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if glycerol 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 glycerol phenylbutyrate:

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

  • Glycerol phenylbutyrate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get glycerol phenylbutyrate refilled.
  • Take glycerol phenylbutyrate by mouth with food.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If the patient is taking glycerol phenylbutyrate through a nasogastric (NG) tube or gastric tube, follow the instructions for use in the Medication Guide.
  • Take glycerol phenylbutyrate on a regular schedule to get the most benefit from it.
  • Continue to take glycerol phenylbutyrate even if you feel well. Do not miss any doses.
  • If you miss a dose of glycerol phenylbutyrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

  • Glycerol phenylbutyrate may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use glycerol phenylbutyrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Follow the dietary plan given to you by your health care provider.
  • Tell your doctor or dentist that you take glycerol phenylbutyrate before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests may be performed while you use glycerol phenylbutyrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Glycerol phenylbutyrate should not be used in CHILDREN younger than 2 months old; they could be at risk for serious side effects.
  • Glycerol phenylbutyrate should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using glycerol phenylbutyrate while you are pregnant. It is not known if glycerol phenylbutyrate is found in breast milk. Do not breast-feed while taking glycerol phenylbutyrate.

Possible side effects of glycerol 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:

Decreased appetite; diarrhea; dizziness; gas; mild stomach pain or nausea; vomiting.

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; wheezing); confusion; cough; drowsiness; fainting; flushing; headache; hearing problems; light-headedness; memory problems; new or worsening numbness, tingling, or burning of the hands or feet; severe or persistent dizziness, headache, or nausea; shortness of breath; taste changes; tiredness; weakness.

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 glycerol phenylbutyrate:

Store glycerol phenylbutyrate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep glycerol phenylbutyrate out of the reach of children and away from pets.

General information:

  • If you have any questions about glycerol phenylbutyrate, please talk with your doctor, pharmacist, or other health care provider.
  • Glycerol 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 glycerol 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 glycerol phenylbutyrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to glycerol 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 health care provider for complete information about the risks and benefits of using glycerol phenylbutyrate.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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