Carbaglu
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 are recommended.
1.2 Maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency
Carbaglu® is indicated for maintenance therapy in pediatric and adult patients for chronic hyperammonemia due to the 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 reduced or discontinued based on plasma ammonia levels.
History
There is currently no drug history available for this drug.
Other Information
Carbaglu tablets for oral administration 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: C6H10N2O5
The inactive ingredients of Carbaglu are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate.
Sources
Carbaglu Manufacturers
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Orphan Europe, Sarl
![Carbaglu (Carglumic Acid) Tablet [Orphan Europe, Sarl]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Carbaglu | Orphan Europe, Sarl
Carbaglu� treatment should be initiated by a physician experienced in metabolic disorders.
2.1 �� �Adult Dosage and Administration
The recommended initial dose for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day.� Concomitant administration of other ammonia lowering therapies is recommended.� Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.
The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.� Based on limited data in 22 patients receiving maintenance treatment with Carbaglu� in a retrospective case series, maintenance doses were usually less than 100 mg/kg/day.
The total daily dose should be divided into 2 to 4 doses and rounded to the nearest 100 mg (i.e., half of a Carbaglu� Tablet).
2.2 �� �Preparation for Oral Administration in Adults
Carbaglu� tablets should not be swallowed whole or crushed. Disperse Carbaglu� tablets in water immediately before use.
Each 200 mg tablet should be dispersed in a minimum of 2.5 mL of water and taken immediately.� Carbaglu� tablets do not dissolve completely in water and undissolved particles of the tablet may remain in the mixing container. �
To ensure complete delivery of the dose, the mixing container should be rinsed with additional volumes of water and the contents swallowed immediately.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
2.3 �� �Preparation for Nasogastric Tube Administration in Adults
For patients who have a nasogastric tube in place, Carbaglu� should be administered as follows:
Mix each 200 mg tablet in a minimum of 2.5 mL of water. Shake gently to allow for quick dispersal. Administer the dispersion immediately through the nasogastric tube. Flush with additional water to clear the nasogastric tube.2.4 �� �Pediatric Dosage and Administration
The recommended initial dose for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day.� Concomitant administration of other ammonia lowering therapies is recommended.� Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.
The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.� Based on limited data in 22 patients receiving maintenance treatment with Carbaglu� in a retrospective case series, maintenance doses were usually less than 100 mg/kg/day.
The total daily dose should be divided into 2 to 4 doses.
2.5 �� �Preparation for Oral Administration Using an Oral Syringe in Pediatrics
For administration via oral syringe, Carbaglu� should be administered as follows:
Mix each 200 mg tablet in 2.5 mL of water to yield a concentration of 80 mg/mL in a mixing container.� Shake gently to allow for quick dispersal. Draw up the appropriate volume of dispersion in an oral syringe and administer immediately.� Discard the unused portion. Refill the oral syringe with a minimum volume of water (1-2 mL) and administer immediately.2.6 �� �Preparation for Nasogastric Tube Administration in Pediatrics
For patients who have a nasogastric tube in place, Carbaglu� should be administered as follows:
Mix each 200 mg tablet in 2.5 mL of water to yield a concentration of 80 mg/mL in a mixing container.� Shake gently to allow for quick dispersal. Draw up the appropriate volume of dispersion and administer immediately through a nasogastric tube.� Discard the unused portion. Flush with additional water to clear the nasogastric tube.
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