Use and safety of azithromycin in neonates: a systematic review

Abstract

ObjectivesTo identify the use and adverse drug reactions associated with azithromycin in neonates.SettingDatabases MEDLINE (1948–August 2015), EMBASE (1980–August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates.ParticipantsAll studies involving neonates (<28 days old) who have received at least a single dose of azithromycin for which safety was evaluated.Primary and secondary outcome measuresThe primary outcome was adverse event (AE) associated with use of azithromycin. Use of azithromycin in neonates was the secondary outcome.ResultsA total of 11 articles involving 473 neonates were identified. 371 AEs were reported. Adverse events were mainly respiratory (358/1000 neonate), neurological (273/1000 neonates) and gastrointestinal (196/1000 neonates) in origin. Azithromycin significantly reduced the risk of bronchopulmonary dysplasia (BPD) in extremely premature neonates (RR=0.83, 95% CI 0.71 to 0.98, p=0.02). There was no significant difference in the incidence of elevated liver enzymes between the azithromycin and placebo group (p=0.76). There were four cases of infantile hypertrophic pyloric stenosis (IHPS).ConclusionsAzithromycin significantly reduces the risk of BPD in preterm neonates. The relationship between azithromycin and IHPS requires further investigation.

Advances in emerging treatment options to prevent bronchopulmonary dysplasia

“…The association was strongest if the exposure occurred in the first two weeks after birth [57]. There are no reported cases of cardiac side effects as seen in adults, in infants treated with azithromycin [56].…”

“…In a subsequent systematic review of 11 trials which included 473 infants azithromycin was demonstrated to reduce BPD in extremely low birth weight (ELBW) infants (RR 0.83, 95% CI 0.72 -0.98, p=0.02) [56]. There was no significant difference in the incidence of elevated liver enzymes, but there were four cases of hypertrophic pyloric stenosis [56].…”

“…Azithromycin administration was associated with a reduction in BPD (relative risk (RR) 0.83, 95% CI 0.71 -0.97) and the combined outcome of BPD and death, but no significant change in mortality [49]. In a subsequent systematic review of 11 trials which included 473 infants azithromycin was demonstrated to reduce BPD in extremely low birth weight (ELBW) infants (RR 0.83, 95% CI 0.72 -0.98, p=0.02) [56]. There was no significant difference in the incidence of elevated liver enzymes, but there were four cases of hypertrophic pyloric stenosis [56].…”

Pathophysiological mechanisms and pharmacological methods of prevention and treatment of bronchopulmonary dysplasia in preterm infants

“…Methods of pharmacological treatment. In prophylactic procedure, attempts are being made to use retinol, caffeine citrate, inhaled nitric oxide, beta-adrenomimetics, ipratropium bromide, diuretics and in newborns with confirmed colonization or infected with Ureaplasma urealyticum, also macrolide antibiotics, mainly azithromycin [50,51]. According to evidence-based data, GCSs are the unique recommended method of prevention of BPD in children and can significantly improve the short-term prognosis of patients [52][53][54][55][56].…”

Antibiotics and its altered pharmacokinetics in the pediatric population : An evidence-based review

“…Azithromycin exerts a bacteriostatic effect against many Gram-positive and Gram-negative bacte-ria (Mcmullan and Mostaghim, 2015). However, oral and intravenous formulations of azithromycin are not recommended for children less than 6 months and 16 years, respectively, due to the lack of adequate clinical studies in this population (Smith et al, 2015).…”