Selection of dose regimens of azithromycin

Foulds, George; Johnson, Raymond B.

doi:10.1093/jac/31.suppl_e.39

Cited by 85 publications

(42 citation statements)

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“…15 The long half-life allows for once-daily dosing, while sustained high-tissue concentrations for several days after dosing permit shorter-course therapy. 16 Once-daily azithromycin given over 5 days (30 mg/kg total dose) is as effective…”

Section: Introductionmentioning

confidence: 99%

A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children

Arguedas¹,

Loaiza²,

Pérez³

et al. 2003

Current Therapeutic Research

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Background: The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children.Objective: This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children.Methods: In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30.Results: Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), Presented in part at the 4th International Conference on the Macrolides, Azalides, Streptogramins, and Ketolides (ICMASK), Barcelona, Spain, January 21-23, 1998.Accepted for publication July 1, 2003July 1, . doi:10.1016July 1, /j.curtheres.2003.005 Reproduction in whole or part is not permitted.0011-393X/03/$19.00 A16Copyright ą 2003 Excerpta Medica, Inc. A. Arguedas et al.and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively. Conclusion: In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens. (Curr Ther Res Clin Exp. 2003;64[Suppl A]:A16-A29)

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Section: Introductionmentioning

confidence: 99%

A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children

Arguedas¹,

Loaiza²,

Pérez³

et al. 2003

Current Therapeutic Research

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“…15,16 The preferential uptake by phagocytes leads to concentrations in infected tissues, which are much higher than in similar noninfected sites. 12 Another important property of azithromycin is that in tablet, suspension and sachet form it may be given without regard to meals, further enhancing the convenience of once-daily, short-duration dosing regimens.…”

Section: N B R I E Fmentioning

confidence: 99%

Azithromycin and dentistry — a useful agent?

Addy

Martin²

2004

Br Dent J

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“…Concentration-versus-time curves feature high, sustained drug concentrations in tissues and comparatively low concentrations in serum ( Figure 5). 13 The prolonged elimination half-life (Ͼ60 hours) allows for once-daily dosing. 3 In a study of children with AOM, azithromycin 10 mg/kg administered on day 1 followed by 5 mg/kg on day 2 achieved mean peak middle-ear fluid concentrations of 8.6 and 9.4 µg/mL at 24 and 48 hours after the initial dose, respectively.…”

Section: Pharmacokinetic Support For Short-course Azithromycin Therapymentioning

confidence: 99%

“…Previous studies have shown a correlation between the serum and tissue PK of azithromycin. 13 Thus, a single, large dose may be preferable to multiple divided doses for achieving optimal tissue concentrations.…”

Section: Pharmacokinetic Support For Short-course Azithromycin Therapymentioning

confidence: 99%

Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynamic rationale

Rothermel

2003

Current Therapeutic Research

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The pharmacokinetic (PK) and pharmacodynamic (PD) properties of the azalide azithromycin distinguish it from other antibiotics. The PK profile of azithromycin features high tissue-to-serum ratios, including high concentrations in the middle ear, and a prolonged elimination half-life. These characteristics result from the accumulation of drug within cells and its subsequent slow, sustained release from cells and tissues into the bloodstream. The PD properties of azithromycin include bactericidal activity against key respiratory tract pathogens and a prolonged postantibiotic, or persistent, effect. In addition, white blood cells deliver the drug to infected foci, thereby enhancing local tissue concentrations and improving in vivo efficacy. Recent PK studies in mice suggest that a single, large dose of azithromycin achieves higher tissue concentrations than do multidose regimens. Other studies in animal infection models, in particular, a gerbil model of acute otitis media, have demonstrated improved bacterial eradication when azithromycin is administered as a single dose rather than divided over 2 or 3 days. Taken together, the results from these preclinical studies provide a PK/PD rationale for the use of single-dose azithromycin in the treatment of acute otitis media. Clinical data on the efficacy and safety of single-dose azithromycin for the treatment of acute otitis media in children are presented in 2 accompanying articles in this supplement. (Curr Ther Res Clin Exp. 2003;64[Suppl A]:A4-A15)

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Selection of dose regimens of azithromycin

Cited by 85 publications

References 0 publications

A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children

A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children

Azithromycin and dentistry — a useful agent?

Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynamic rationale

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