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Raplon
Clinical Pharmacology
Raplon
a=time from injection to maximum block (peat effect)
b= (100.% T1 control at peak effect)
c=time from injection to return to 25% of control T1
d=time from injection to recovery of 70% T4/T1
in U.S. clinical trials, in geriatric patients (≥
65 years), the mean (SD) time to maximum block [[time
from injection to maximum block (peak effect)] following an initial 2.5 mg/kg dose of RAPLONÒ was 51 (21) seconds (n=4). The mean (SD) clinical duration (time from injection to return to 25% of control T1) was 43 (37) minutes (n=13) with a mean (SD) 25%-75%T1 recovery index of 17 (16) minutes (n=3) and a mean (SD) time to 70%T4/T1 recovery (n=9) of 76 (20) minutes (time from injection to recovery of 70% T4/T1).
Table 5 presents the neuromuscular function parameters following an initial dose of RAPLONÒ in pediatric patients under halothane anesthesia.
TABLE 5" Neuromuscular Function Parameters Following an Initial Dose of RAPLONÒ in Pediatric patients (1 month to ≥ 12 years)
| Age Group | Dosage | Time to Maximum Blocka (sec) | Maximum Blockb (%) | Clinical Durationc (min) | 25%-75%T1 Recovery Index (min) | Time to 70%T4/T1 recoveryc (min) |
| Infants (1mo to < 2yrs) | RAPLON Ò 1 mg/kg (n=14) | 88 (73) | 96 (12) | 9 (3) (n=13) | 7 (4) (n=9) | 20 (7) (n=12) |
| RAPLONÒ 2 mg/kg (n=16) | 84 (66) | 99 (3) | 16 (7) | 13 (11) (n=8) | 34 (13) | |
| Children (2 to 12yrs) | RAPLONÒ 2 mg/kg (n=23) | 53 (16) | 100 (1) | 14 (7) | 6 (4) (n=19) | 26 (9) (n=21) |
| RAPLONÒ 3 mg/kg (n=21) | 67 (44) | 100 (2) | 18 (3) (n=20) | 11 (6) (n=12) | 37 (9) (n=19) |
a=time from injection to maximum block (peak effect)
b=(100. % T1 control at peak effect)
c= time from injection to return to 25% of control T1
d= time from injection to recovery of 70% T4/T1
Cardiac Patients
Hemodynamic parameters were assessed in patients with coronary artery and valvular disease receiving 1.5 mg/kg of RAPLONÒ in one European (n=18) placebo controlled trial. Overall, there were mild to moderate changes in hemodynamic parameters (e.g., mean arterial pressure, heart rate, mean pulmonary artery pressure, pulmonary capilary wedge pressure, central venous pressure, cardiac index , and systemic vascular resistance index) measured invasively, in cardiac patients (valvular disease or coronary artery disease) receiving 1.5 mg/kg RAPLONTM
Generic Name: Rapacuronium
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