Table I.
Dolasetron 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 | 0.0000996 | 0.00119 | 0.00289 | 0.00244 |
| Clark’s Rulea, c | 0.00169 | 0.00227 | 0.00264 | 0.00340 |
| Modified Weight Rulea, d | 0.00230 | 0.00310 | 0.00361 | 0.00463 |
| Body surface areaa, e | 0.00400 | 0.00400 | 0.00400 | 0.00400 |
| FDA-approved labeled dosef | Not indicated | Not indicated | 0.00324 | 0.00417 |
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 100 mg/ml
aIn calculating pediatric dose for each subpopulation and from each dose formula, the adult dose was taken to be 100 mg
bFrom Young’s Rule, the dose was calculated to be 0.346, 7.99, 36.8, and 53.8 mg for neonates, infants, children, and adolescents, respectively
cClark’s Rule employs weight, which was taken to be the 50 percentile boy weight in the CDC growth charts for neonates, infants, children, and adolescents (17,18). From Clark’s Rule, the dose was calculated to be 5.87, 15.3, 33.7, and 74.8 mg for neonates, infants, children, and adolescents, respectively
dModified Weight Rule employs weight, which was taken to be the 50 percentile boy weight in the CDC growth charts for neonates, infants, children, and adolescents (17,18). From Modified Weight Rule, the dose was calculated to be 8.00, 20.9, 46, and 102 mg for neonates, infants, children, and adolescents, respectively
eBody surface area employs height and weight, which were taken to be the 50 percentile boy value in the CDC growth charts for neonates, infants, children, and adolescents (17,18). From body surface area, the dose was calculated to be 13.9, 27.0, 51.0, and 88.1 mg for neonates, infants, children, and adolescents, respectively
fThe FDA-approved labeled dose for prevention of chemotherapy induced nausea and vomiting from the package insert is 1.8 mg/kg for the pediatric population >2 years old (9). From FDA-approved label dose, the dose was calculated to be 41.4 and 91.8 mg for children and adolescents, respectively. FDA-approved labeled dose employs weight, which were taken to be the 50 percentile boy value in the CDC growth charts for children and adolescents (17,18)