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Toleration of intravenous azithromycin
1Department of Clinical Research, Pfizer Central Research, Groton, CT 06340, USA.
The Annals of Pharmacotherapy
|September 20, 1997
Summary
Single intravenous doses of azithromycin up to 2 mg/mL were well tolerated in healthy men. Higher concentrations (4-5 mg/mL) led to increased infusion site reactions like erythema and tenderness.
Area of Science:
- Pharmacology
- Clinical Trials
Background:
- Azithromycin is a widely used antibiotic administered intravenously.
- Understanding optimal infusion concentrations is crucial for patient toleration and safety.
Purpose of the Study:
- To evaluate the toleration of various intravenous azithromycin infusion concentrations.
- To identify safe and well-tolerated concentrations for single-dose administration.
Main Methods:
- A randomized, double-blind, crossover study involving 24 healthy men.
- Subjects received single 1-hour intravenous infusions of azithromycin (1 g) at concentrations of 1, 2, 4, or 5 mg/mL, compared to placebo.
- Infusion site reactions were assessed using visual analog scales, supplemented by Doppler ultrasound.
Main Results:
- Infusion site reactions, including erythema and tenderness, increased with higher azithromycin concentrations (4 and 5 mg/mL).
- No significant trends were observed in Doppler readings.
- Azithromycin at concentrations up to 2 mg/mL showed good toleration.
Conclusions:
- Single intravenous doses of azithromycin 1 g administered over 1 hour are well tolerated at concentrations up to 2 mg/mL in healthy men.
- Higher concentrations may lead to local infusion site reactions, necessitating careful consideration of concentration during administration.