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
