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Abelcet
CLINICAL PHARMACOLOGY
Abelcet
Pharmacokinetics
The assay used to measure amphotericin B in the blood after the administration of ABELCET® does not distinguish amphotericin B that is complexed with the phospholipids of ABELCET® from amphotericin B that is uncomplexed.
The pharmacokinetics of amphotericin B after the administration of ABELCET® are non linear. Volume of distribution and clearance from blood increase with increasing dose of ABELCET®, resulting in less than proportional increases in blood concentrations of amphotericin B over a dose range of 0.6-5 mg/kg/day. The pharmacokinetics of amphotericin B in whole blood after the administration of ABELCET® and amphotericin B desoxycholate are:
| Pharmacokinetic Parameters of Amphotericin B in Whole Blood in Patients Administered Multiple Doses of ABELCET® or Amphotericin B Desoxycholate | ||
| Pharmacokinetic Parameter | ABELCET ® | Amphotericin B |
| 5 mg/kg/day for 5-7 days | 0.6 mg/kg/day for 42 daysa | |
| Mean ± SD | Mean ± SD | |
| Peak Concentration (mg/mL) | 1.7 ± 0.8 ( n= 10)b | 1.1 ± 0.2 (n= 5) |
| Concentration at End of Dosing Interval (mg/mL) | 0.6 ± 0.3 ( n= 10)b | 0.4 ± 0.2 ( n= 5) |
| Area Under Blood Concentration-Time Curve | ||
| (AUC 0-24h)(µg*h/mL) | 14 ± 7 ( n= 14)b, c | 17.1 ± 5 (n= 5) |
| Clearance (mL/ h* kg) | 436 ± 188.5 ( n= 14)b, c | 38 ± 15 (n= 5) |
| Apparent Volume of Distribution (Vdarea) (L/kg) | 131 ± 57.7 (n= 8) | 5 ± 2.8 (n= 5) |
| Terminal Elimination Half-Life (h) | 173.4 ± 78 ( n= 8)c | 91.1 ± 40.9 (n= 5) |
| Amount Excreted in Urine Over 24 h | ||
| After Last Dose (% of dose)d | 0.9 ± 0.4 ( n= 8)c | 9.6 ± 2.5 (n= 8) |
- a Data from patients with mucocutaneous leishmaniasis. Infusion rate was 0.25 mg/kg/h.
- b Data from studies in patients with cytologically proven cancer being treated with chemotherapy or neutropenic patients with presumed or proven fungal infection. Infusion rate was 2.5mg/kg/h.
- c Data from patients with mucocutaneous leishmaniasis. Infusion rate was 4 mg/kg/h.
- d Percentage of dose excreted in 24 hours after last dose.
The large volume of distribution and high clearance from blood of amphotericin B after the administration of ABELCET® probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of ABELCET® 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of ABELCET® has not been studied.
Generic Name: Amphotericin B
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