Carbaglu

Product manufactured by Orphan Europe, Sarl

Application Nr Approved Date Route Status External Links
NDA022562 2010-03-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Carbaglu Is A Carbamoyl Phosphate Synthetase 1 (cps 1) Activator Indicated As: Adjunctive Therapy For The Treatment Of Acute Hyperammonemia Due To The Deficiency Of The Hepatic Enzyme N-Acetylglutamate Synthase (nags). ( 1.1) Maintenance Therapy For The Treatment Of Chronic Hyperammonemia Due To The Deficiency Of The Hepatic Enzyme N-Acetylglutamate Synthase (nags). ( 1.2) 1.1 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. 1.2 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). During Maintenance Therapy, The Concomitant Use Of Other Ammonia Lowering Therapies And Protein Restriction May Be Needed Based On Plasma Ammonia Levels.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
4. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Carglumic Acid

Comments