Sodium phenylbutyrate

Generic name: Sodium Phenylbutyrate
Drug class: Urea cycle disorder agents

Usage of Sodium phenylbutyrate

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

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

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

Sodium phenylbutyrate side effects

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

Sodium phenylbutyrate 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 sodium phenylbutyrate 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.

Before taking Sodium phenylbutyrate

Sodium phenylbutyrate 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 (sodium phenylbutyrate oral pellet contains sucrose); or

liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

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How to use Sodium phenylbutyrate

Usual Adult Dose for Urea Cycle Disorders:

Administer orally in equally divided doses with each meal or feeding (i.e., 3 to 6 times a day):-Weight: Less than 20 kg: 450 to 600 mg/kg/day -Weight: 20 kg or Greater: 9.9 to 13 g/m2/dayComments: -Treatment should be combined with dietary protein restriction and, in some cases, essential amino acidsupplementation. Uses: -Adjunctive therapy in the chronic management of urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase. -Indicated for treatment of neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life) and late-onset disease (partial enzymatic deficiency, presenting after the first month of life) with history of hyperammonemic encephalopathy.

Usual Pediatric Dose for Urea Cycle Disorders:

Administer orally in equally divided doses with each meal or feeding (i.e., 3 to 6 times a day):-Weight: Less than 20 kg: 450 to 600 mg/kg/day -Weight: 20 kg or Greater: 9.9 to 13 g/m2/dayComments: -Treatment should be combined with dietary protein restriction and, in some cases, essential amino acidsupplementation. -Tablets are not recommended in patients weighing less than 20 kg. Uses: -Adjunctive therapy in the chronic management of UCDs involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase. -Indicated for treatment of neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life) and late-onset disease (partial enzymatic deficiency, presenting after the first month of life) with history of hyperammonemic encephalopathy.

Warnings

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

What other drugs will affect Sodium phenylbutyrate

Tell your doctor about all your other medicines, especially:

steroids;

haloperidol;

valproic acid; or

probenecid.

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

Disclaimer

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