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 spoonsalso 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.

Table 1.

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

2 Yin HS, Parker RM,. Sanders LM, et al. Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment. Pediatrics. 2016;138(4):e20160357. doi:10.1542/peds.2016-0357
Shah R, Blustein L, Kuffner E, Davis L. Communicating doses of pediatric liquid medicines to parents/caregivers: a comparison of written dosing directions on prescriptions with labels applied by dispensed pharmacy. J Pediatr. 2014;164(3):596–601, e591 [PubMed] [Google Scholar]
McMahon SR, Rimsza ME, Bay RC. Parents can dose liquid medication accurately. Pediatrics. 1997;100(3 pt 1):330–333 [PubMed] [Google Scholar]
5 Yaffe SJ, Bierman CW, Cann HM, et al. . Inaccuracies in administering liquid medication. Pediatrics. 1975;56(2):327–328 [PubMed] [Google Scholar]
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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.