Sodium Phenylbutyrate (SOE-dee-um fen-il-BUE-ti-rate)

Treats urea cycle disorders to help remove nitrogen from the body.

Brand Name(s):

Buphenyl, Pheburane

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Pellet, Powder, Tablet, Coated Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• If you are using the oral powder, you can mix it with water or food (solid or liquid). Powder mixed with food should be used right away. Powder mixed in water can be stored for up to one week at room temperature or in the refrigerator.
• Olpruva™ oral liquid:
  • Pour the entire contents of the Mix-Aid packet into 4 ounces of water in a cup and stir with spoon for 30 seconds to make the water thicker.
  • Add the Olpruva™ in the mixture and stir for 15 seconds. Take the mixture within 5 minutes to prevent the coating from dissolving.
  • Pour another 4 ounces of water in the cup to make sure you get full dose.
  • Throw away the mixture if you have not taken it within 30 minutes of mixing.
  • Do not give this medicine through a feeding tube.
• Pheburane® oral pellets:
  • Measure the medicine with a marked measuring spoon.
  • You may swallow the oral pellets with a drink (including water, fruit juices, protein-free infant formulas) or you may sprinkle the pellets with apple sauce or carrot puree. Take the mixture right away.
  • Do not chew the pellets directly or mix with liquids.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Carefully follow your doctor's instructions about any special diet.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Pheburane® oral pellets: If you have less than 3 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away unused Pheburane® oral pellets 45 days after opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sodium phenylbutyrate works. Tell your doctor if you are using haloperidol, probenecid, valproic acid, or steroid medicines (including dexamethasone, prednisolone, prednisone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, edema (swelling), diabetes, or if you have a history of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
• This medicine may cause nerve problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, headache, sleepiness, tiredness
• Decrease in how much or how often you urinate
• Dry mouth, increased thirst, muscle cramps, uneven heartbeat
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe menstrual bleeding
• Severe vomiting or rectal bleeding
• Sudden or severe stomach pain, nausea, vomiting, fever, lightheadedness
• Swelling in your hand, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Decreased appetite
• Depression
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088