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Raplon

Clinical Pharmacology
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Clinical Pharmacology

EC50. Mcg.mL

2.06(55)

ED90, mg/kg

0.46(33)

The ED50 for rapacuronium bromide (dose required to produce 50% suppression of the first [T1] mechanomyographic [MMG] response of the adductor pollicis muscle to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg in adult (18 to 64 years) and geriatric (> 65 years) patients. The ED50 for rapacuronium bromide for pediatric patients (1 to 12 years) is 0.4 mg/kg and for infants (1 month to < 1 year) is 0.3mg/kg (see PRECAUTIONS, Pediatric Use).

Table 3 and 4 present the neuromuscular function parameters following an initial dose of RAPLONTM in adult patients (18 to 64 years) and geriatric patients (> 65 years).

TABLE 3: Neuromuscular Function Parameters (Mean SD)) Following and Initial Dose of RAPLONTM in Adults (18 to 64 years)

Dosage

Time to Maximum Blocka (sec)

Maximum Blockb (%)

Clinical Duration (min)c

25%-75% T1 Recovery Index (min)

Time to 70% T4/T1 recovered (min)

RAPLONÒ

1.5 mg/kg

88 (47)

(n=32)

99 (2)

(n=49)

15 (5)

(n=57)

9 (5)

(n=38)

34 (15)

(n=47)

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

In U.S. clinical trials, in adult patients (18 to 64 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 72 (24) seconds (n=19). The mean (SD) clinical duration (time from injection to return to 25% of control T,) in adult patients was 24 (8) minutes (n=45) with a mean (SD) 25 %-75%T, recovery index of 13 (7) minutes (n=23) and a mean (SD) time to 70% T,/T,).

TABLE 4: Neuromuscular Function Parameters (Mean (SD) Following an Initial Dose of RAPLONÒ in Geriatric Patients (2 65 years)

Dosage

Time to Maximum Blocka (sec)

Maximum Blockb (%)

Clinical Durationc (min)

25%-74%T1 Recovery Index (min)

Time to 70%T4/T1 recoveryc (min)

RAPLONÒ

1.5 mg/kg

89 (6)

(n=6)

98 (5)

(n=17)

17 (5)

(n=16)

11 (6)

(n=4)

36 (5)

(n=12)

Brand Name: Raplon
Generic Name: Rapacuronium
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