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Raplon

Clinical Pharmacology
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Clinical Pharmacology

Raplon

Early Reversal

Administration of neostigmine (50 or 70 mcg/kg at 2 or 5 min) at profound neuromuscular block (>90%) following administration of either 1.5 or 2.5 mg/kg of RAPLONTM (rapacuronium bromide) for Injection in adults reduced the recovery time by approximately 50%. After early reversal with neostigmine, a decrease in neuromuscular function did not occur over the clinical trial period.

Table 7 presents the recovery parameters following reversal of profound block from a US study of adult patients. Anesthesia consisted of premedication with midazolam, induction with fentanyl and propofol, and maintenance with N2O supplemented with fentanyl and propofol.

TABLE 7: Recovery Profile Following Neostigmine Reversal at Profound RAPLONTM-induced Block (> 90%) in Adults (18 to 64 years)

RAPLONTM Dose

Neostigmine Dose

Time of Neostigmine Administration

Clinical Duration (min)

25%-75% T1 Recovery Index (min)

Time to 70% T4/T1 recovery (min)

Time to 80% T4/T1 recovery (min)

 

1.5 mg/kg

None

N/A (n=11)

17(5)a

12(5)a

38(10)a

43(12)a

50mcg/kg

2 min (n=7)

8(1)

5(1)

17(4)

20(5)

5 min (n=12)

9(1)

5(3)

17(3)

19(4)

70mcg/kg

2 min (n=10)

8(1)

7(4)

15(3)

21(7)

5 min (n=9)

9(1)

6(2)

19(8)

24(8)

 

2.5 mg/kg

None

N/A (n=10)

24(5)a

15(6)a

56(13)a

60(11)a

50 mcg/kg

2 min(n=12)

12(2)

9(4)

26(7)

31(8)

5 min(n=8)

12(3)

8(3)

32(13)

38(18)

70mcg/kg

2 min (n=9)

12(2)

12(5)b

35(8)

41(10)

5 min(n=9)

12(2)

8(3)

28(9)

36(12)

Brand Name: Raplon
Generic Name: Rapacuronium
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