Glycerol phenylbutyrate Oral solution

What is this medicine?

GLYCEROL PHENYLBUTYRATE (gli ser ol fen il bue ti rate) is used to manage the amount of ammonia in the blood of patients with urea cycle disorders. This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• intestine problems

• kidney disease

• liver disease

• pancreatic disease

• an unusual or allergic reaction to glycerol phenylbutyrate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take this medicine with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

This medicine is used in combination with a low protein diet. Some patients may also need to take dietary supplements.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• haloperidol

• probenecid

• steroid medicines like prednisone or cortisone

• valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Call your doctor or go to the nearest hospital if you have shortness of breath, wheezing, cough, low blood pressure, flushing, nausea, or a rash while taking this medicine.

This medicine can cause serious nervous system problems. Call your doctor or get help right away if you develop sleepiness, weakness, confusion, problems hearing, or other nervous system side effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in taste

• confusion

• decreased hearing

• feeling faint or lightheaded, falls

• headache

• loss of memory

• pain, tingling, numbness in the hands or feet

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• bloating

• diarrhea

• dizziness

• loss of appetite

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 68 and 77 degrees F (20 and 25 degrees C). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.