IngentaConnect Absence of Drug Interaction between Oral Moxifloxacin and Intramu...

Abstract:

Objective: To determine the effects of intramuscular morphine sulfate on the pharmacokinetics of moxifloxacin.

Design: This was a single-centre, randomised, two-way, nonblinded crossover study in healthy young males and females.

Participants: 20 healthy volunteers (15 males, five females) with a mean age of 34 years were enrolled and considered evaluable for the pharmacokinetic analysis.

Methods: Moxifloxacin was given under two conditions separated by a minimum 7-day washout period: alone as a single oral 400mg dose, and immediately following 10mg of intramuscular morphine sulfate. Concentrations of moxifloxacin in serum were determined by a validated HPLC procedure with fluorescence detection.

Outcome Measures and Results: Pharmacokinetic parameters estimated were maximum serum concentration (C), time to reach C (t), area under the concentration-time curve from zero to infinity (AUC), and terminal elimination half-life (t). The natural logarithms of AUC and C were compared by analysis of variance. The mean moxifloxacin serum concentration vs time profiles were similar between the two treatments. The geometric least square mean C values for moxifloxacin were 3.42 mg/L when given alone vs 2.85 mg/L with morphine, producing a ratio (moxifloxacin with morphine vs moxifloxacin alone) of 0.83, with a 90% confidence interval (CI) about the ratio of 0.71 to 0.98. The geometric mean AUC values for moxifloxacin alone and with morphine were 41.5 and 39.6 mg/L·h; the ratio of means was 0.96, with a 90% CI of 0.87 to 1.04. t and t values for moxifloxacin were unchanged when coadministered with morphine. The single oral dose of moxifloxacin 400mg was well tolerated when taken with and without morphine sulfate.

Conclusions: Administration of a single intramuscular dose of morphine did not reduce the bioavailability or alter the elimination profile of oral moxifloxacin. These results suggest that concurrent administration of intramuscular morphine and oral moxifloxacin is unlikely to reduce the efficacy of the quinolone.

Keywords: Antibacterials, drug interactions; Drug interactions; Morphine, drug interactions; Moxifloxacin, drug interactions; Opioids, drug interactions

Language: English

Document Type: Original article

Affiliations: 1: Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut, USA *

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Absence of Drug Interaction between Oral Moxifloxacin and Intramuscular Morphine Sulfate in Healthy Volunteers