Carglumic acid
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| Clinical data | |
|---|---|
| Trade names | Carbaglu, Ucedane |
| Other names | (S)-2-ureidopentanedioic acid |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | By mouth |
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| Pharmacokinetic data | |
| Bioavailability | 30% |
| Protein binding | Undetermined |
| Metabolism | Partial |
| Elimination half-life | 4.3 to 9.5 hours |
| Excretion | Fecal (60%) and kidney (9%, unchanged) |
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| ECHA InfoCard | 100.116.323 |
| Chemical and physical data | |
| Formula | C6H10N2O5 |
| Molar mass | 190.155 g·mol−1 |
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Carglumic acid, sold under the brand name Carbaglu among others, is used for the treatment of hyperammonaemia.[3][6][7] Carglumic acid is a carbamoyl phosphate synthetase 1 (CPS 1) activator.[3]
The most common adverse effects include vomiting, abdominal pain, pyrexia (fever), and tonsillitis, anemia, diarrhea, ear infection, other infections, nasopharyngitis, decreased hemoglobin levels, and headache.[3]
It was approved for medical use in the United States in March 2010.[8] Carglumic acid is an orphan drug.[9][10] It is available as a generic medication.[11]
Medical uses
[edit]Carglumic acid is indicated for the treatment of acute hyperammonemia and chronic hyperammonemia.[3][4][5]
References
[edit]- ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
- ^ a b c d e "Carbaglu- carglumic acid tablet". DailyMed. Retrieved 9 June 2021.
- ^ a b "Carbaglu EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 9 June 2021.
- ^ a b "Ucedane EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 9 June 2021.
- ^ Caldovic L, Morizono H, Daikhin Y, Nissim I, McCarter RJ, Yudkoff M, Tuchman M (2004). "Restoration of ureagenesis in N-acetylglutamate synthase deficiency by N-carbamylglutamate". J Pediatr. 145 (4): 552–4. doi:10.1016/j.jpeds.2004.06.047. PMID 15480384.
- ^ Elpeleg O, Shaag A, Ben-Shalom E, Schmid T, Bachmann C (2002). "N-acetylglutamate synthase deficiency and the treatment of hyperammonemic encephalopathy". Ann Neurol. 52 (6): 845–9. doi:10.1002/ana.10406. PMID 12447942. S2CID 24604774.
- ^ "Drug Approval Package: Carbaglu (Carglumic Acid) Tablets". U.S. Food and Drug Administration (FDA). 16 February 2010. Retrieved 9 June 2021.
- ^ "Carglumic acid Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 17 June 2014. Retrieved 9 June 2021.
- ^ "Carglumic acid Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 20 January 1998. Retrieved 9 June 2021.
- ^ "Competitive Generic Therapy Approvals". U.S. Food and Drug Administration (FDA). 29 June 2023. Archived from the original on 29 June 2023. Retrieved 29 June 2023.
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