Pharmacokinetics in children
No information
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Hyperammoniaemia |
- Intravenous
-
<
20 kg
After dilution in 10% glucose: Initial dose: 250 mg/kg sodium benzoate and 250 mg/kg sodium phenylacetate intravenous infusion in 90 to 120 minutes, only via a central line. Maintenance dose: 250 mg/kg sodium benzoate and 250 mg/kg sodium phenylacetate intravenous infusion in 24 hours, only via a central line
-
≥ 20 kg
After dilution in 10% glucose: Initial dose: Loading dose: 5.5 g/m² sodium benzoate and 5.5 g/m² sodium phenylacetate intravenous infusion in 90 to 120 minutes, only via a central line. Maintenance dose: Maintenance dose: 5.5 g/m² sodium benzoate and 5.5 g/m² sodium phenylacetate intravenous infusion in 24 hours, only via a central line.
|
Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects
No information is present at this moment.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Possible tissue necrosis on extravasation of Ammonul during rapid bolus infusion, particularly in infants.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS |
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A16AB03
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A16AB04
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A16AB07
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A16AB13
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A16AB22
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A16AA06
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A16AA05
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A16AB17
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A16AX10
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A16AB08
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A16AX09
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A16AX
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A16AB09
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A16AB02
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A16AB05
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A16AA01
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A16AX18
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A16AA04
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A16AX06
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A16AX04
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A16AX07
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A16AB14
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A16AX08
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A16AX07
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A16AB10
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A16AX05
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References
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Ucyclyd Pharma, Inc, FDA Label Ammonul, http://www.accessdata.fda.gov, http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf
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Enns GM, et al, Survival after treatment with phenylacetate and benzoate for urea-cycle disorders, N Engl J Med, 2007, May 31;356(22), 2282-92
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Summar ML, et al, Diagnosis, symptoms, frequency and mortality of 260 patients with urea cycle disorders from a 21-year, multicentre study of acute hyperammonaemic episodes, Acta Paediatr, 2008, Oct;97(10), 1420-5
Therapeutic Drug Monitoring
Overdose