Amantadine Hydrochloride Oral Solution Dispenser

Pediatric Dosing Information

The current Prescribing Information (PI), for the administration of Amantadine Hydrochloride oral solution 50 mg per 5 mL, recites; for pediatric patients 1 to 9 years of age a daily dosing of 4.4 mg to 8.8 mg per kilogram weight with a maximum dose of 150 mg/day.1

The PI dosing chart and product label describe the dosage equivalent of amantadine hydrochloride oral solution of 50 mg per 5 mL (1 teaspoonful). 1

Conversely, the PI does not describe the extrapolation of the 4.4 mg or 8.8 mg (8.8% – 17.6%), from the 5 mL suspension required for the further conversion for dosing to an individual patient kilogram as prescribed.

More importantly, the Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommendations to reduce risk for toxicity provide a recommended dose of 50 mg per 5 mL, Amantadine Hydrochloride Oral Solution for 1 to 9 years: 5 mg/kg orally per day in 2 divided (2.5mg/kg) doses; not to exceed 150 mg/day. 2

In contrast this enhanced narrowed dosing regimen as recommended by the ACIP and AAP administered through the Dose-Weight Syringe® would provide the administration of an exact dose of 2.5 mg/kg twice daily providing for a consistent optimal dose of the Amantadine Hydrochloride Oral Solution to small mass pediatric patients compared to the variable dosing provided by current recommended dosing, see table 1.

Table 1. Current dosing verses Dose-2-Weight ® Dosing

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All labeling and dosing representation on this website is for informational and promotional purposes only.  It should not be used for prescribing or administering these products. Please contact your physician or a health care professional for all preparation and administration directions.