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SPB11
  • Treatments
  • Urea Cycle Disorders
  • SPB11 (Oral)

SPB11 (Oral)

Generic name: sodium phenylbutyrate (oral route) [ SOE-dee-um-fen-il-BUE-ti-rate ]
Drug class:Urea cycle disorder agents

Medically reviewed by Drugs.com. Last updated on Jun 5, 2022.

Commonly used brand name(s)

In the U.S.

  • Buphenyl
  • SPB11

Available Dosage Forms:

  • Powder
  • Tablet

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Histone Deacetylase Inhibitor

Uses for SPB11

Sodium phenylbutyrate is used together with a proper diet to help treat urea cycle disorders (including a specific liver enzyme deficiency) that help remove ammonia (nitrogen) from the body.

Ammonia is formed from the breakdown of protein in the body. If the ammonia cannot be removed by the body, then a buildup may cause serious unwanted effects. This medicine works by helping to reduce high levels of ammonia in the blood.

This medicine is available only with your doctor's prescription.

Before using SPB11

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because of sodium phenylbutyrate's toxicity, use in children weighing less than 20 kilograms (44 pounds) is not recommended.

Geriatric

No information is available on the relationship of age to the effects of sodium phenylbutyrate in geriatric patients.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Edema (swelling from excess fluids in the body) or
  • Heart disease or
  • Heart failure or
  • Kidney disease, severe—Increased retention of water may make these conditions worse.
  • Kidney dise...