Uses of Sodium Phenylbutyrate Powder:

• It is used to treat urea cycle problems.

What do I need to tell my doctor BEFORE I take Sodium Phenylbutyrate Powder?

For all patients taking sodium phenylbutyrate powder:

• If you have an allergy to sodium phenylbutyrate or any other part of sodium phenylbutyrate powder.
• If you are allergic to sodium phenylbutyrate powder; any part of sodium phenylbutyrate powder; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Divalproex, haloperidol, or valproic acid.

Children:

• If your child weighs less than 44 lb (20 kg). This medicine is not for use in children who weigh less than 44 lb (20 kg).

This is not a list of all drugs or health problems that interact with sodium phenylbutyrate powder.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take sodium phenylbutyrate powder with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sodium Phenylbutyrate Powder?

• Tell all of your health care providers that you take sodium phenylbutyrate powder. This includes your doctors, nurses, pharmacists, and dentists.
• Follow the diet plan that your doctor told you about.
• Wear disease medical alert ID (identification).
• If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using sodium phenylbutyrate powder while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Sodium Phenylbutyrate Powder) best taken?

Use sodium phenylbutyrate powder as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals.
• Shake before use.
• Mix powder with soft food.
• Use only the scoop that comes with the powder to measure powder.
• After mixing, give the dose right away. Do not store for future use.
• Those who have feeding tubes may use sodium phenylbutyrate powder. Use as you have been told. Flush the feeding tube after sodium phenylbutyrate powder is given.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with a meal.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• Feeling sleepy.
• Fever.

What are some other side effects of Sodium Phenylbutyrate Powder?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Not hungry.
• Bad taste in your mouth.
• Change in body odor.
• No period or other period (menstrual) changes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sodium Phenylbutyrate Powder?

• Store at room temperature.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about sodium phenylbutyrate powder, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.