Table VII.
Ciprofloxacin HCl Pediatric Dose Number for Various Pediatric Subpopulations
| Dose formula | Neonates (0–1 months) |
Infant (1–24 months) |
Children (2–12 years) |
Adolescents (12–16 years) |
|---|---|---|---|---|
| Young’s Rulea, b | 0.498 | 5.93 | 14.4 | 12.2 |
| Clark’s Rulea, c | 8.44 | 11.4 | 13.2 | 17.0 |
| Modified Weight Rulea, d | 11.5 | 15.5 | 18.0 | 23.2 |
| Body surface areaa, e | 20.0 | 20.0 | 20.0 | 20.0 |
| FDA-approved labeled dosef | Not indicated | 20.7 | 24.0 | 22.7 |
Age was taken to be the mid-point of the subpopulation age (i.e., 0.5 months, 12.5 months, 7 years, and 14 years for neonates, infants, children, and adolescents, respectively). Conversion from dose to dose number employed a BSA-derived volume of 34.7, 67.4, 127.6, and 220.3 ml for neonates, infants, children, and adolescents, respectively. BSA employed height and weight, which were taken to be the 50 percentile boy value in the CDC growth charts for 0.5 months, 12.5 months, 7 years, and 14 years for neonates, infants, children, and adolescents, respectively (17,18). Drug solubility was taken to be 0.150 mg/ml (14)
aIn calculating pediatric dose for each subpopulation and from each dose formula, the adult dose was taken to be 750 mg
bYoung’s Rule employs age, which was taken to be the mid-point of the subpopulation age (i.e., 0.5 months, 12.5 months, 7 years, and 14 years for neonates, infants, children, and adolescents, respectively). From Young’s Rule, the dose was calculated to be 2.60, 59.9, 276, and 404 mg for neonates, infants, children, and adolescents, respectively
cClark’s Rule employs weight, which was taken to be the 50 percentile of boy values in the CDC growth charts for ages neonates, infants, children, and adolescents (17,18). From Clark’s Rule, the dose was calculated to be 44.0, 115, 253, and 561 mg for neonates, infants, children, and adolescents, respectively
dModified Weight Rule employs weight, which was taken to be the 50 percentile of boy values in the CDC growth charts for ages neonates, infants, children, and adolescents (17,18). From Modified Weight Rule, the dose was calculated to be 60.0, 157, 345, and 765 mg for neonates, infants, children, and adolescents, respectively
eBody surface area employs height and weight, which were taken to be the 50 percentile of boy values in the CDC growth charts for ages neonates, infants, children, and adolescents (17,18). From body surface area, the dose was calculated to be 104, 202, 383, and 661 mg for neonates, infants, children, and adolescents, respectively
fThe FDA-approved labeled dose for community-acquired pneumonia from the package insert is 20 mg/kg for the pediatric population > 1 year old (13). From FDA-approved label dose, the dose was calculated to be 209, 460, and 750 mg for infants, children, and adolescents, respectively (13). FDA-approved labeled dose employs weight, which were taken to be the 50 percentile boy value in the CDC growth charts for infants, children, and adolescents (17,18)