Riferimento farmaci
Glycerol phenylbutyrate
Glycerol phenylbutyrate is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: US FDA label, EMA SmPC
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- A16AX09
- Forme farmaceutiche comuni
- soluzione
- Dosaggi comuni
- 1.1 g/ml
- Interazioni note
- 28 (Maggiore: 3 · Moderata: 12 · Minore: 13)
- Nomi commerciali
- 2
- Paesi e mercati
- 2
Come agisce
RAVICTI is a triglyceride containing 3 molecules of PBA. Its active moiety PAA conjugates with glutamine in the liver and kidneys to form PAGN, which the kidneys excrete. PAGN contains 2 moles of nitrogen, like urea, and provides an alternate route for waste nitrogen excretion.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
UCD, phenylbutyrate-naive patients: 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day) orally, given in 3 equally divided doses in patients 2 years and older; starting dose 4.5 mL/m2/day for patients with some residual enzyme activity; maximum total daily dosage 17.5 mL
Gravidanza e allattamento
- Gravidanza
- Unknown Limited human data are insufficient to inform risk. Animal studies showed maternal toxicity and, at higher doses in rats, reduced fetal weights and skeletal variations.
- Allattamento
- Unsafe No human milk data. Because of potential for serious adverse reactions in the infant, breastfeeding is not recommended.
Effetti indesiderati segnalati
- Diarrhea
- Flatulence
- Headache
- Abdominal pain
- Vomiting
- Decreased appetite
Controindicazioni
- Known hypersensitivity to phenylbutyrate.
Chi deve prestare attenzione
- Neurotoxicity: PAA may be toxic; reduce dosage for neurotoxicity symptoms.
- Pancreatic insufficiency or intestinal malabsorption may reduce drug absorption and ammonia control; monitor ammonia closely.
- Not indicated for acute hyperammonemia.
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 (28)
- Dexamethasone + Glycerol phenylbutyrate Major
- Glycerol phenylbutyrate + Sodium valproate Major
- Glycerol phenylbutyrate + Valproic acid Major
- Cyclosporin + Glycerol phenylbutyrate Moderate
- Dexamethasone-neomycin-polymyxin + Glycerol phenylbutyrate Moderate
- Dexamethasone-tobramycin + Glycerol phenylbutyrate Moderate
- Fludrocortisone + Glycerol phenylbutyrate Moderate
- Glycerol phenylbutyrate + Haloperidol Moderate
- Glycerol phenylbutyrate + Hydrocortisone Moderate
- Glycerol phenylbutyrate + Methylprednisolone Moderate
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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
- IV preparation and dilution
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Domande frequenti
What is Glycerol phenylbutyrate used for?
Glycerol phenylbutyrate is a medicine in the class miscellaneous.
What side effects have been reported with Glycerol phenylbutyrate?
Diarrhea, Flatulence, Headache, Abdominal pain, Vomiting, Decreased appetite.
Can Glycerol phenylbutyrate be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Limited human data are insufficient to inform risk. Animal studies showed maternal toxicity and, at higher doses in rats, reduced fetal weights and skeletal variations. Breastfeeding: Unsafe. No human milk data. Because of potential for serious adverse reactions in the infant, breastfeeding is not recommended.
What does Glycerol phenylbutyrate interact with?
MediHelp lists 28 known interactions for Glycerol phenylbutyrate. Major: 3 · Moderate: 12 · Minor: 13. The most serious include Dexamethasone, Sodium valproate, Valproic acid.
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