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Carglumic Acid
Overview
What is Carbaglu?
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, 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.
The structural formula is:
Molecular Formula: C
H
N
O
The inactive ingredients of CARBAGLU are croscarmellose sodium, hypromellose, microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulfate, sodium stearyl fumarate.
What does Carbaglu look like?
What are the available doses of Carbaglu?
Tablets for oral suspension: 200 mg, functionally scored (
)
What should I talk to my health care provider before I take Carbaglu?
How should I use Carbaglu?
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.
CARBAGLU treatment should be initiated by a physician experienced in metabolic disorders. Based on clinical experience, the treatment may be started as early as the first day of life.
CARBAGLU tablets are uncoated and should not be swallowed whole or crushed. Disperse CARBAGLU tablets in water immediately before use. For all preparations, use in other foods and liquids has not been studied clinically and is therefore not recommended.
What interacts with Carbaglu?
Sorry No Records found
What are the warnings of Carbaglu?
Sorry No Records found
What are the precautions of Carbaglu?
Sorry No Records found
What are the side effects of Carbaglu?
Sorry No records found
What should I look out for while using Carbaglu?
None
What might happen if I take too much Carbaglu?
One patient treated with 650 mg/kg/day of carglumic acid developed symptoms characterized as a monosodium glutamate intoxication-like syndrome: tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and restlessness. These symptoms resolved upon reduction of dose.
Repeated oral dosing of carglumic acid at 2000 mg/kg/day was lethal to most neonatal rats within 2-3 days of treatment. The plasma concentrations that produced lethality were not measured. In adult rats, a single oral administration of carglumic acid was not lethal at doses up to 2800 mg/kg (approximately 20 times the maximum starting dose based on C
).
How should I store and handle Carbaglu?
Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:How SuppliedCARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored and coded “C” on one side.CARBAGLU is available in 5 or 60 tablets in a high density polyethylene bottle with child resistant polypropylene cap and desiccant unit.NDC 52276-312-05 Bottles of 5 tabletsNDC 52276-312-60 Bottles of 60 tabletsStorageStore in the original unopened container at 2 – 8 °C (36 – 46 °F).After first opening of the container:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG) which is produced from glutamate and acetyl-CoA in a reaction catalyzed by N‑acetylglutamate synthase (NAGS), a mitochondrial liver enzyme. NAG acts as an essential allosteric activator of Carbamoyl Phosphate Synthetase 1 (CPS 1), a mitochondrial liver enzyme which catalyzes the first reaction of the urea cycle. The urea cycle, whose role is the disposition of ammonia, includes a series of biochemical reactions in the liver resulting in the conversion of ammonia into urea, which is then excreted through the urine. Carglumic acid acts as a CPS1 activator in patients with NAGS deficiency, thereby removing the block in the urea cycle and facilitating ammonia detoxification and urea production.
Non-Clinical Toxicology
NoneAny episode of acute symptomatic hyperammonemia should be treated as a life-threatening emergency. Treatment of severe hyperammonemia may require dialysis, preferably hemodialysis and/or hemofiltration, to reduce plasma ammonia concentration. Untreated hyperammonemia can result in brain damage and death, and prompt use of all therapies necessary to reduce plasma ammonia level is essential.
Since hyperammonemia in NAGS deficiency is the result of imbalance between ammonia detoxification capacity and protein catabolism, complete protein restriction during an acute hyperammonemic episode is recommended for no longer than 12 to 36 hours while maximizing caloric supplementation to reverse catabolism. Protein should be reintroduced as early as possible, following improvement of metabolic and clinical abnormalities in this setting. During long-term management, dietary protein restriction should be instituted to maintain blood ammonia level within an acceptable range for age.
Ongoing monitoring of plasma ammonia level, neurological status, growth parameters, protein intake/nutritional status (both during acute hyperammonemic episodes and long-term), and relevant laboratory tests in patients receiving CARBAGLU should be part of evaluating the clinical response to treatment.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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