Hydrocodone Bitartrate and Acetaminophen Oral Solution Dispenser
Pediatric Dosing Information
The current Prescribing Information (PI), for the administration of hydrocodone bitartrate oral solution for pediatric patients with a body weight of 12 kg to 45 kg recite: “usual dosages” pursuant to table 1, corresponding to an average individual dose of 0.27 mL/kg providing 0.135 mg/kg of hydrocodone bitartrate and 9.0 mg/kg of Acetaminophen. 1
The PI further indicates, “that dosing should be based upon weight whenever possible” and “it is the utmost importance that the product be administered accurately”. Additional cautionary dosing language includes, “a household teaspoon or tablespoon is not an adequate measuring device, especially when measuring one-half or three-fourths of a teaspoon” and, “caregivers should use extreme caution in measuring the dosage and it strongly recommended that care givers obtain a calibrated measuring device. 1
Contrary to all the precautionary statements regarding the dosing accuracy of this narcotic analgesic, the PI directions recite household spoons1 also contradictory to the American Academy of Pediatrics (AAP) and the US Food and Drug Administration (FDA), published statements, that non-standard kitchen spoons are not recommended as a dosing apparatus for medicinal solutions. 2,3,4,5
More importantly, the inaccuracy of measuring this narcotic medication for small mass pediatric patients by household spoons is exacerbated by the “average individual dose” of 0.27 mL per kg body weight. This dosing method provides for highly variable dosing and perhaps subtherapeutic or supratherapeutic dosing of children between these defined weight ranges. The current dosing does not provide a consistent accurate dose of 0.135 mg/kg of hydrocodone bitartrate and 9.0 mg/kg of acetaminophen, (0.27 mL) as clinically recommended for pediatric use, see table 2.
The Dose-Weight Syringe® is specifically calibrated to administer a patient specific dose of 0.27mL/kg providing for an optimal dose of 0.135 mg of hydrocodone bitartrate and 9.0 mg of acetaminophen to individualized pediatric body weight.