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Carbaglu (carglumic acid) tablets 200mg

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Carbaglu (carglumic acid) tablets 200mg

Carbaglu (carglumic acid) tablets 200mg 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).

• Maintenance therapy for the treatment of chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).

ADVERSE REACTIONS

The most common adverse reactions in ≥ 13% of patients are: infections, vomiting, abdominal pain, pyrexia, tonsilitis, anemia, ear infection, diarrhea, nasopharyngitis, and headache.

USE IN SPECIFIC POPULATIONS

Pregnancy: No human data; decreased survival and growth in animal offspring. Nursing Mothers: Human milk-feeding is not recommended.

 

DOSAGE AND ADMINISTRATION

Carbaglu treatment should be initiated by a physician experienced in metabolic disorders Adult Dosage and Administration

Carbaglu (carglumic acid) tablets 200mg

• Recommended initial dose range for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day.

• Adjust dose to maintain normal plasma ammonia levels based on age.

• Divide the total daily dose into two to four doses to be given immediately before meals or feedings.

• Each divided dose should be rounded to the nearest 100 mg.

• Each 200 mg tablet should be dispersed in a minimum of 2.5 ml of water and taken immediately.

• Carbaglu can be administered orally or through a nasogastric tube.

• Carbaglu tablets should not be swallowed whole or crushed. Pediatric Dosage and Administration

• Recommended initial dose range for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day.

• Divide the total daily dose into two to four doses to be given immediately before meals or feedings.

• Mix each 200 mg tablet in 2.5 ml of water to yield a concentration of 80 mg/mL.

• Carbaglu may be administered orally with an oral syringe or through a nasogastric tube.

 

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