Azithromycin Oral Suspension Dispenser
Pediatric Dosing Information
The current Prescribing Information (PI), for the administration of Azithromycin oral suspension (200 mg/5 mL), for pediatric patients 20 kg to 50 kg recites; a suggested dose of 5 mL (1 tsp) for a 10.0 kg patient weight with otitis media, acute bacterial sinusitis, and community acquired pneumonia infections, table 1.
The PI further describes patient dosing for children over 6 months of age should be based on body weight and calculated for 10.0 mg/kg/day for day-1 and 5.0 mg/kg/day for day 2-5. The PI also provides for the dosing measurement equivalent in teaspoons.1
Conversely, the PI does not describe the extrapolation of 5.0 mg or 10.0 mg (2.5% – 5.0%) from the 5 mL-200mg suspension and/or teaspoon nor for 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 the calculation and measurement procedures required to perform by health care providers.
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
More importantly, the directions obviate any dosing directions for children between the defined weights ranges listed, as well as any method for obtaining the optimal dosing for the 5.0 mg/kg or 10.0 mg/kg Azithromycin oral suspension as prescribed. The preparation and administration directions solely provide for a recommended daily dose based upon a weight range in 10-kilogram increments and not to a child’s specific kg body weight as described in the PI nor recommended by the pediatric dosage guidelines1, see table 1. This dosing regimen provides highly variable dosing and perhaps subtherapeutic dosing to children within the weight ranges and does not provide a consistent accurate milligram dose to a child’s individual body weight as recommended. In addition, the variable dosing may be exacerbated by the inaccuracy of measuring this medication by household spoons, see table 2 & 3.
The Dose-Weight Syringe® is specifically calibrated to administer a patient specific dose of Azithromycin oral suspension, 200 mg/5 mL to the optimal dose of 5.0 mg or 10.0 mg of body weight as recommended.
Table 1. Suggested doses for pediatric patients.
Table 2. Current Dosing Day 1 – verses – Dose-2-Weight ® Dosing Day 1
Table 3. Current Dosing Day 2-5 – verses – Dose-2-Weight ® Dosing Day 2-5
