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Carglumic Acid Dosage

Applies to the following strength(s): 200 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Hyperammonemia

The total daily dose should be divided into 2 to 4 doses and rounded to the nearest 100 mg.

Initial dose: 100 to 250 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals. Concomitant administration of other ammonia lowering therapies is recommended. Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.

Maintenance dose: Usually less than 100 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals. The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.

Usual Pediatric Dose for Hyperammonemia

The total daily dose should be divided into 2 to 4 doses.

Initial dose: 100 to 250 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals or feedings.

Concomitant administration of other ammonia lowering therapies is recommended. Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.

Maintenance dose: Usually less than 100 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals or feedings.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Each divided dose of carglumic acid should be rounded to the nearest 100 mg.

Plasma ammonia levels should be maintained within normal range for age via individual dose adjustment.

During acute hyperammonemic episodes, concomitant administration of carglumic acid with other ammonia lowering therapies such as alternate pathway medications, hemodialysis, and dietary protein restriction is recommended. During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be reduced or discontinued based on plasma ammonia levels.

In the initial treatment of N-acetylglutamate synthase (NAGS) deficiency, protein restriction is recommended. When plasma ammonia level is normalized, dietary protein intake can usually be reintroduced.

Dialysis

Data not available

Other Comments

Carglumic acid should be administered prior to meals or feedings.

Carglumic acid 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.

Dissolving carglumic acid tablets in foods or liquids other than water has not been studied clinically and is not recommended by the manufacturer.

When administering carglumic acid to patients with a nasogastric tube in place, each 200 mg tablet should be mixed in 2.5 mL of water to yield a concentration of 80 mg/mL in a mixing container. The mixing container should be shaken gently and its contents immediately drawn up and administered through the nasogastric tube. The nasogastric tube should then be cleared by flushing with water. Any unused portion of the carglumic acid mixture should be discarded.

When administering carglumic acid to pediatric patients via oral syringe, each 200 mg tablet should be mixed in 2.5 mL of water to yield a concentration of 80 mg/mL in a mixing container. The mixing container should be shaken gently and its contents immediately drawn up in the syringe and administered. The syringe should then be refilled with 1 to 2 mL of water and administered. Any unused portion of the carglumic acid mixture should be discarded.

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