Sodium phenylbutyrate (By mouth)

Introduction

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, SPB11

When This Medicine Should Not Be Used

How to Use This Medicine

Powder, Tablet, Coated Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• 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.
• Carefully follow your doctor's instructions about any special diet.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are using probenecid (Benemid®) or steroids (such as dexamethasone, prednisolone, prednisone, Celestone®, Cortone®, Decadron®, Deltasone®, or Pediapred®). Tell your doctor if you are also using haloperidol (Haldol®) or valproic acid (Depakene®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart disease, kidney disease, liver disease, or edema (swelling from excess fluid).
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Decrease in how much or how often you urinate.
• Heart rhythm problems.
• 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, or 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 in monthly periods.
• Depression.
• Headache or weight gain.
• Nausea or mild stomach pain.

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