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

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

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

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

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.

Take Pheburane with food.

Shake the oral powder lightly before mixing it with food.

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

Swallow Pheburane 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 Pheburane oral suspension and oral pellets through a gastrostomy or nasogastric tube

Your blood may need to be tested often.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any remaining oral pellets 45 days after first opening the bottle.

Pheburane 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 (Pheburane oral pellet contains sucrose); or

• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pheburane may cause serious side effects. Call your doctor at once if you have:

• 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 of Pheburane 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.

Tell your doctor about all your other medicines, especially:

• steroids;

• haloperidol;

• valproic acid; or

• probenecid.

This list is not complete. Other drugs may affect Pheburane, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.