Comparison of azithromycin pharmacokinetics following single oral doses of extended-release and immediate-release formulations in children with acute otitis media

Antimicrobial Agents and Chemotherapy

Volumn 55, Issue 11, 2011, Pages 5022-5026

  Liu, Ping ^a   Fang, Annie F ^a   LaBadie, Robert R ^a   Crownover, Penelope H ^a   Arguedas, Adriano G ^b  

^a PFIZER INC   (United States)

^b Instituto de Atencion Pediatrica Costa Rica   (Costa Rica)

Author keywords

[No Author keywords available]

Indexed keywords

AZITHROMYCIN; CEFTRIAXONE; PARACETAMOL;

ACUTE OTITIS MEDIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CHILD; CLINICAL ARTICLE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DIARRHEA; DRUG DOSAGE FORM COMPARISON; DRUG WITHDRAWAL; FEMALE; HUMAN; IMMEDIATE RELEASE FORMULATION; INFANT; MALE; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSTAINED RELEASE FORMULATION; TREATMENT RESPONSE; VOMITING;

ANTI-BACTERIAL AGENTS; AZITHROMYCIN; CHEMISTRY, PHARMACEUTICAL; CHILD; CHILD, PRESCHOOL; HUMANS; INFANT; OTITIS MEDIA;

EID: 80054692858     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00692-11     Document Type: Article

References (16)

1. Andes, D. 2001. Pharmacokinetic and pharmacodynamic properties of anti-microbials in the therapy of respiratory tract infections. Curr. Opin. Infect. Dis. 14:165-172. (Pubitemid 32232987)
2. Arguedas, A., et al. 2005. A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media. Pediatr. Infect. Dis. J. 24:153-161. (Pubitemid 40250775)
3. Arguedas, A., C. Loaiza, J. Ferris, and D. Jorgensen. 2007. Tolerability of extended-release azithromycin pediatric suspension (PEDS-AZM) vs. extended-release azithromycin adult suspension (ADULT-AZM) in children with acute otitis media (AOM), abstr. G-981. Abstr. 47th Intersci. Conf. Antimicrob. Agents Chemother., Chicago, IL, 17 to 20 September 2007.
4. Arguedas, A., C. Soley, and D. Jorgensen. 2006. Single, high-dose azithromycin extended release (60 mg/kg) (AZ-ER) vs. 10 days high-dose amoxicillin clavulanate (AC) in children with acute otitis media (AOM) at high risk of persistent/recurrent otitis media (HR-P/ROM), abstr. G-347a. Abstr. 46th Intersci. Conf. Antimicrob. Agents Chemother., San Francisco, CA, 27 to 30 September 2006.
5. Chandra, R., et al. 2007. Clinical pharmacokinetics and gastrointestinal tolerability of a novel extended-release microsphere formulation of azithromycin. Clin. Pharmacokinet. 46:247-259. (Pubitemid 46425650)
6. Craig, W. A. 2001. Does the dose matter? Clin. Infect. Dis. 33(Suppl. 3): S233-S237. (Pubitemid 32835797)
7. Dunne, M. W., et al. 2003. Efficacy of single-dose azithromycin in treatment of acute otitis media in children after a baseline tympanocentesis. Antimicrob. Agents Chemother. 47:2663-2665. (Pubitemid 36919477)
8. FDA. 2003. Bioavailability and bioequivalence studies for orally administered drug products - general considerations. FDA, Washington, DC.
9. Girard, D., S. M. Finegan, M. W. Dunne, and M. E. Lame. 2005. Enhanced efficacy of single-dose versus multi-dose azithromycin regimens in preclinical infection models. J. Antimicrob. Chemother. 56:365-371. (Pubitemid 41158527)
10. Jacobs, R. F., et al. 2005. Pharmacokinetics of intravenously administered azithromycin in pediatric patients. Pediatr. Infect. Dis. J. 24:34-39. (Pubitemid 40353314)
11. Khurana, C. M. 1996. A multicenter, randomized, open label comparison of azithromycin and amoxicillin/clavulanate in acute otitis media among children attending day care or school. Pediatr. Infect. Dis. J. 15:S24-S29.
12. Periti, P., T. Mazzei, E. Mini, and A. Novelli. 1993. Adverse effects of macrolide antibacterials. Drug Saf. 9:346-364. (Pubitemid 23325295)
13. Pfizer Inc. 2010. Zithromax: azithromycin immediate release United States package insert. Pfizer Inc., New York, NY.
14. Pfizer Inc. 2010. Zmax: azithromycin extended release United States package insert. Pfizer Inc., New York, NY.
15. Soley, C. A., and A. Arguedas. 2005. Single-dose azithromycin for the treatment of children with acute otitis media. Expert Rev. Anti Infect. Ther. 3:707-717. (Pubitemid 41535392)
16. Weber, F. H., Jr., R. D. Richards, and R. W. McCallum. 1993. Erythromycin: a motilin agonist and gastrointestinal prokinetic agent. Am. J. Gastroenterol. 88:485-490.