CARBAGLU tablets for oral suspension, contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a Carbamoyl Phosphate Synthetase 1 (CPS 1) activator and is soluble in boiling water, slightly soluble in cold water, and practically insoluble in organic solvents.
Chemically carglumic acid is N-carbamoyl-L-glutamic acid or
(2S)-2-(carbamoylamino) pentanedioic acid, with a molecular weight of 190.16.
Molecular Formula: C6H10N2O5
The inactive ingredients of CARBAGLU are croscarmellose sodium, hypromellose,
microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulfate,
sodium stearyl fumarate.
INDICATIONS
Acute Hyperammonemia In Patients With NAGS Deficiency
CARBAGLU is indicated as an adjunctive therapy in pediatric and adult patients
for the treatment of acute hyperammonemia due to the deficiency of the hepatic
enzyme N-acetylglutamate synthase (NAGS). During acute hyperammonemic episodes,
concomitant administration of CARBAGLU with other ammonia lowering therapies,
such as alternate pathway medications, hemodialysis, and dietary protein
restriction, is recommended.
Chronic Hyperammonemia In Patients With NAGS Deficiency
CARBAGLU is indicated as maintenance therapy in pediatric and adult patients
for the treatment of chronic hyperammonemia due to deficiency of the hepatic
enzyme N-acetylglutamate synthase (NAGS). Named patient program, During maintenance
therapy, the concomitant use of other ammonia lowering therapies and protein
restriction may be needed based on plasma ammonia levels.
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