The current Prescribing Information (PI), for the administration of amoxicillin oral suspension (125mg/5mL) for neonates and infants 12 weeks or under for severe infection, recites; a daily dose of 30.0 mg per patient kilogram in divided doses of 15.0 mg/kg every 12 hours.¹

The PI dosing chart and product label describe the dosage equivalent of 125 mg of amoxicillin trihydrate per 5 mL of reconstituted suspension.

Conversely, the PI does not describe the extrapolation of the 30.0 mg or 15.0 mg (12% – 24%) from the 5 mL – 125 mg suspension nor the subsequent conversion to an individual kilogram patient dose as prescribed.

This dosing regimen provides for an elevated risk of error and inaccurate dosing, due to required calculations and measurement procedures the health care provider must perform.

Moreover, dozens of studies conclude that a household teaspoon is not an adequate measuring device.² According to the American Academy of Pediatrics (AAP) and the US Food and Drug Administration (FDA), among other health agencies, non-standard kitchen spoons are not recommended as a dosing apparatus for medicinal solutions. ^2,3,4,5

¹ https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d&type=display
² https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5051204/
³ Yin HS, Mendelsohn AL, Wolf MS, et al. . Parents’ medication administration errors: role of dosing instruments and health literacy. Arch Pediatr Adolesc Med. 2010;164(2):181–186 [PubMed]
⁴ Madlon-Kay DJ, Mosch FS.. Liquid medication dosing errors. J Fam Pract. 2000;49(8):741–744[PubMed]
⁵ Sobhani P, Christopherson J, Ambrose PJ, Corelli RL.. Accuracy of oral liquid measuring devices: comparison of dosing cup and oral dosing syringe. Ann Pharmacother. 2008;42(1):46–52 [PubMed]

Not Available in All Territories.
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.