Carglumic Acid Tablets
Dosage form: tablet, for oral suspension
Drug class:Miscellaneous uncategorized agents
Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.
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INDICATIONS & USAGE
Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency
Carglumic Acid Tablets for oral suspension are indicated in pediatric and adult patients as:
- Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency.
- Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
DOSAGE & ADMINISTRATION
Recommended Dosage for Acute or Chronic Hyperammonemia due to NAGS Deficiency
Treatment Initiation
Initiate Carglumic Acid Tablets for oral suspension treatment as soon as the diagnosis of NAGS deficiency is suspected, which may be as soon as at birth, and managed by a physician and medical team experienced in metabolic disorders.
Dosage for Acute Hyperammonemia due to NAGS Deficiency
- The recommended daily dosage of Carglumic Acid Tablets for oral suspension in pediatric and adult patients for acute hyperammonemia due to NAGS deficiency is 100 mg/kg to 250 mg/kg.
- Divide the daily dosage into 2 to 4 doses and round to the nearest 100 mg (i.e., half of a carglumic acid tablet for oral suspension).
- During acute hyperammonemic episodes, administer Carglumic Acid Tablets for oral suspension with other ammonia lowering therapies, such as alternate pathway medications, hemodialysis, and protein restriction.
Dosage for Chronic Hyperammonemia due to NAGS Deficiency
- The recommended daily dosage of Carglumic Acid Tablets for oral suspension in pediatric and adult patients for chronic hyperammonemia due to NAGS deficiency is 10 mg/kg to 100 mg/kg.
- Divide the daily dosage into 2 to 4 doses and round to the nearest 100 mg (i.e., half of a Carglumic acid tablet for oral suspension).
- 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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