Riferimento farmaci
Sodium phenylbutyrate
Sodium phenylbutyrate is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- A16AX03
- Forme farmaceutiche comuni
- compressa, polvere
- Dosaggi comuni
- 483 mg/g
- Interazioni note
- 3 (Maggiore: 1 · Moderata: 2)
- Nomi commerciali
- 4
- Paesi e mercati
- 2
Come agisce
Prodrug metabolized to phenylacetate, which conjugates with glutamine to form phenylacetylglutamine; this is excreted by the kidneys, providing an alternate route for waste nitrogen excretion.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
Urea cycle disorders, patients weighing 20 kg or more: 9.9 - 13 g/m2/day of sodium phenylbutyrate orally in three to six divided doses with food; maximum 20 grams per day
Gravidanza e allattamento
- Gravidanza
- Unsafe No human data. In rats, prenatal exposure to its active metabolite phenylacetate damaged developing brain cells. Untreated urea cycle disorders are dangerous; specialist care is essential. EU label: contraindicated in pregnancy, with effective contraception; US label: use only if clearly needed.
- Allattamento
- Unknown Not known if it passes into milk. EU label: contraindicated while breastfeeding (brain damage in rat pups given phenylacetate). LactMed: highly protein bound, unlikely in important amounts; not a reason to stop, but use with caution with a newborn and watch for sedation or vomiting.
Effetti indesiderati segnalati
- Amenorrhea or menstrual dysfunction
- Decreased appetite
- Body odor
- Bad taste or taste aversion
Chi deve prestare attenzione
- Neurotoxicity from phenylacetate; consider dose reduction if symptoms are present.
- Hypokalemia: urinary potassium loss; monitor serum potassium.
- Sodium content may cause edema; discontinue if new or worsening edema occurs.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (3)
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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Domande frequenti
What is Sodium phenylbutyrate used for?
Sodium phenylbutyrate is a medicine in the class miscellaneous.
What side effects have been reported with Sodium phenylbutyrate?
Amenorrhea or menstrual dysfunction, Decreased appetite, Body odor, Bad taste or taste aversion.
Can Sodium phenylbutyrate be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. No human data. In rats, prenatal exposure to its active metabolite phenylacetate damaged developing brain cells. Untreated urea cycle disorders are dangerous; specialist care is essential. EU label: contraindicated in pregnancy, with effective contraception; US label: use only if clearly needed. Breastfeeding: Unknown. Not known if it passes into milk. EU label: contraindicated while breastfeeding (brain damage in rat pups given phenylacetate). LactMed: highly protein bound, unlikely in important amounts; not a reason to stop, but use with caution with a newborn and watch for sedation or vomiting.
What does Sodium phenylbutyrate interact with?
MediHelp lists 3 known interactions for Sodium phenylbutyrate. Major: 1 · Moderate: 2. The most serious include Sodium valproate, Haloperidol, Probenecid.
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