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Maxipime
CLINICAL PHARMACOLOGY
Maxipime
Pharmacokinetics
The average plasma concentrations of cefepime observed in healthy adult male volunteers (n=9) at various times following single 30-minute infusions (IV) of cefepime 500 mg, 1 g, and 2 g are summarized in Table 1. Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2.0 (±0.3) hours and total body clearance of 120.0 (±8.0) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days.
Absorption
The average plasma concentrations of cefepime and its derived pharmacokinetic parameters after intravenous administration are portrayed in Table 1.
TABLE 1: Average Plasma Concentrations in µg/mL of Cefepime
and Derived Pharmacokinetic Parameters (±SD), Intravenous Administration
| MAXIPIME | |||
| Parameter | 500 mg IV | 1 g IV | 2 g IV |
| 0.5 h | 38.2 | 78.7 | 163.1 |
| 1.0 h | 21.6 | 44.5 | 85.8 |
| 2.0 h | 11.6 | 24.3 | 44.8 |
| 4.0 h | 5.0 | 10.5 | 19.2 |
| 8.0 h | 1.4 | 2.4 | 3.9 |
| 12.0 h | 0.2 | 0.6 | 1.1 |
| Cmax, µg/mL | 39.1 (3.5) | 81.7 (5.1) | 163.9 (25.3) |
| AUC, h•µg/mL | 70.8 (6.7) | 148.5 (15.1) | 284.8 (30.6) |
| Number of subjects (male) | 9 | 9 | 9 |
Following intramuscular (IM) administration, cefepime is completely absorbed. The average plasma concentrations of cefepime at various times following a single IM injection are summarized in Table 2. The pharmacokinetics of cefepime are linear over the range of 500 mg to 2 g IM and do not vary with respect to treatment duration.
TABLE 2: Average Plasma Concentrations in µg/mL of Cefepime
and Derived Pharmacokinetic Parameters (±SD), Intramuscular Administration
| MAXIPIME | |||
| Parameter | 500 mg IM | 1 g IM | 2 g IM |
| 0.5 h | 8.2 | 14.8 | 36.1 |
| 1.0 h | 12.5 | 25.9 | 49.9 |
| 2.0 h | 12.0 | 26.3 | 51.3 |
| 4.0 h | 6.9 | 16.0 | 31.5 |
| 8.0 h | 1.9 | 4.5 | 8.7 |
| 12.0 h | 0.7 | 1.4 | 2.3 |
| Cmax, µg/mL | 13.9 (3.4) | 29.6 (4.4) | 57.5 (9.5) |
| Tmax, h | 1.4 (0.9) | 1.6 (0.4) | 1.5 (0.4) |
| AUC, h•µg/mL | 60.0 (8.0) | 137.0 (11.0) | 262.0 (23.0) |
| Number of subjects (male) | 6 | 6 | 12 |
Distribution
Generic Name: Cefepime Hydrochloride for Injection
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