Referência de medicamentos
Sodium phenylbutyrate
Sodium phenylbutyrate is a medicine in the class miscellaneous.
- Classe do medicamento: Miscellaneous
Última atualização Fontes: US FDA label
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Pontos-chave
- Classe do medicamento
- Miscellaneous
- Código ATC
- A16AX03
- Formas farmacêuticas comuns
- comprimido, pó
- Concentrações comuns
- 483 mg/g
- Interações conhecidas
- 3 (Grave: 1 · Moderada: 2)
- Nomes comerciais
- 4
- Países e mercados
- 2
Como funciona
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 habitual em adultos (resumo da bula)
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
Gravidez e amamentação
- Gravidez
- 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.
- Amamentação
- 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.
Efeitos adversos relatados
- Amenorrhea or menstrual dysfunction
- Decreased appetite
- Body odor
- Bad taste or taste aversion
Quem deve ter cuidado
- 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.
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Principais interações (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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Perguntas frequentes
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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