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UntitledManagement of Acute Respiratory Tract Infections in Pediatric Patients Provided as an educational service by
JEROME O. KLEIN, MD Professor of Pediatrics, Boston University School of Medicine, Boston Medical Center, Boston, Massachusetts All rights r
Brought to You by the Publisher of
Table 1. Treatable Microbial Pathogens Responsible
Table 3. Choice of Antimicrobial Agents for Management of AOM
For Acute Respiratory Tract Infections in Children1
Copyright 2010 McMahon Publishing Gr
No Antibiotic in Prior Month
Antibiotic in Prior Month
Amoxicillin (usual or High-dose amoxicillin Acute Otitis Media
High-dose amoxicillin–clavulanateOral cephalosporin: cefdinir, nformation that governs treatment management decisions in infants and children with respiratory tract infections is cefuroxime axetil, cefpodoxime dynamic. New data emerge and guidelines are constantly changing. For example, the clinical implications of antibiotic resistance have raised concerns about the adequacy of currently available antimicrobial agents.While the pneumococ- Ical conjugate vaccine has been successful beyond expectations in decreasing the incidence of invasive bacterial dis- Amoxicillin failure day 3 High-dose amoxicillin–clavulanate
Same as for no antibiotics ease, it has been only modestly beneficial in decreasing the incidence of acute otitis media (AOM). Initiatives to foster Oral cephalosporin: cefdinir, Consider tympanocentesis compliance and avoid drug errors have been proposed following revelation of the human and financial cost of these cefuroxime axetil, cefpodoxime errors. Finally, there has been and will continue to be debate about an anticipated recommendation by the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) to withhold antibiotics from select- ed patients with AOM.This wall chart is an overview of the issues in respiratory tract infection management in infants and AOM, acute otitis media; IM, intramuscular
Modified from reference 5.
children. For more information and a complete list of references, please see the pocket guide that accompanies this chart.
• Although the pneumococcal conjugate vaccine may decrease the proportion of pneumococci causing otitis media, sinusitis, and pneumonia (with a resultant increase in the proportion of infections due to nontypable Haemophilusinfluenzae), the range of pathogens responsible for each respiratory tract disease has not changed in the past 25 Table 4. Efficacy of 7-Valent Pneumococcal Conjugate Vaccine
oduction in whole or in part without permission is pr
years (Table 1).1 +++ important in decision making; ++ occasional pathogen; + selective for age or season; – rare or never • In some children with bacterial AOM, the disease resolves without the use of an antimicrobial agent.2,3 This has In Finnish Children With AOM
prompted some European physicians to withhold antibiotic therapy from children with ear infections.4 Some No. of Episodes
American physicians have considered initial symptomatic therapy (decongestants, pain medications) for selectedchildren with AOM.
Type or Cause of Acute Otitis Media
• There are concerns that antimicrobial drugs used for the many cases of AOM promote antibiotic resistance and data indicate many children do not benefit from use of antibacterial drugs for AOM. A plan of observation rather than antimi-crobial therapy is considered in draft guidelines prepared by the AAP and AAFP (publication is anticipated in late 2003).
Table 2. Antimicrobial Agents for Otitis Media
• The choice of antimicrobial agents is similar for AOM and sinusitis because they share the same pathogenesis and microbiology. Eighteen drugs are approved by the Food and Drug Administration (FDA) for the treatment of AOM And Dosage Schedules1
(Table 2 lists approved antimicrobials).
• Although most experts now agree on the continued use of amoxicillin as the drug of choice for initial treatment of AOM, there is less consensus on the appropriate drug to use when amoxicillin fails. A Centers for Disease Control Number of
and Prevention consensus report from 1999 suggested amoxicillin–clavulanate, cefuroxime axetil, and intramuscu- Drug (Trade Name/Manufacturer)
Doses (per day)
(per kg per day)
lar ceftriaxone (Table 3).5 • There are several reasons children do not receive the recommended regimen for treatment of infections, including those of the respiratory tract. Unacceptable taste or odor of drugs may result in poor adherence to the regimen Amoxicillin (Amoxil,
• Physicians need to be cognizant of the possible sources of error in prescribing drugs for the ambulatory patient, including problems in filling the prescription by the pharmacist and poor adherence to the regimen by the patient 40-80 mg (90 mg for * Hepatitis B vaccine Adapted from data published in reference 11.
AOM, acute otitis media; PCV7, 7-valent pneumococcal conjugate vaccine
ES-600, GlaxoSmithKline) Augmentin ES-600) • Nasal and oral decongestants, administered either alone or in combination with an antihistamine, are used exten- sively for the treatment of otitis media with effusion or sinusitis. Their use is based on the consideration that they oup unless otherwise noted.
reduce congestion of the respiratory mucosa and relieve the obstruction of the orifices to the paranasal sinuses or the eustachian tube. However, the results of clinical trials indicate no significant evidence of efficacy for any of these Cefaclor (Ceclor, Lilly; various)
preparations in the relief of signs of otitis media with effusion,AOM, or acute sinusitis.8,9 • The anticipated guidelines of the AAP and the AAFP address pain associated with AOM.Various products have been Cefdinir (Omnicef, Abbott)
Overall Taste Rating*
used for otalgia and sinus pain, but none have been adequately studied. Mild to moderate pain may be managed with Drugstores not open at time of day when parents seek acetaminophen or ibuprofen or external application of heat or cold. Otic agents may provide brief benefit to patients Cefdinir (Omnicef, Abbott)
over 5 years of age. Narcotic analgesics with codeine or analogs should be reserved for patients with severe pain and may be better managed with myringotomy.
Parent and Home Factors
Cefixime (Suprax, Wyeth; various)
• The pneumococcal 7-valent conjugate vaccine (Prevnar, Wyeth) employing a diphtheria toxin mutant (CRM Difficulty in giving medication—2 people often necessary tein) as the protein carrier was approved by the FDA in February 2000.10 The vaccine was and is very effective in Cefpodoxime proxetil (Vantin, Pfizer; various)
to administer drug reducing the burden of serious life-threatening pneumococcal disease in infants, including bacteremia, bacteremic Use of household teaspoon unsatisfactory; bottles broken pneumonia, and meningitis, but was only modestly successful in reducing the incidence of AOM (Table 4).11 Cefprozil (Cefzil, Bristol-Myers Squibb)
7. Clarithromycin Schedule of administration unrealistic for parent; Ceftibuten (Cedax, Schering)
baby sitter unable to dispense medication Most children with AOM show significant improvement within 48 to 72 hours with appropriate antimicrobial ther- 9. Amoxicillin– apy. It is likely that about one third or more of AOM, acute sinusitis, and pneumonia episodes are due to viral Ceftriaxone (Rocephin, Roche)
pathogens, and children with illness from those pathogens do not benefit from antimicrobial agents. About one fifth Misleading or incorrect labels of children with pneumococcal otitis and half of those with Haemophilus otitis do not need antibacterial drugs.Thus, Cefuroxime axetil (Ceftin, GlaxoSmithKline/
there are many children with AOM who are treated with antibacterial drugs for each one who benefits from therapy.
Underfilling of prescriptions LifeCycle Ventures; various) However, now and for the immediate future, there are no practical methods to distinguish which children can safely * Based on appearance, smell, texture, taste, and aftertaste be observed rather than treated. Until data are available to give us confidence in making this distinction, appropriate- Cephalexin (Keflex, Lilly; various)
Action of drugs and possible side effects not explained ly diagnosed AOM remains a disease that warrants antimicrobial therapy.
This study was conducted among 86 Loracarbef (Lorabid, Monarch)
healthcare professionals and physicians, Cost of expensive trade brand used exceeds Medicaid who tested and evaluated palatability of 1. Klein JO, Management of acute respiratory tract infections in pediatric patients. IDSE. 2003;6:57-60 each antibiotic suspension. Antibiotics reimbursement rate 2. Kaleida PH, Casselbrant ML, Rockette HE, et al.Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial.
were rated on a 0-5 scale. A score of 3 was Dosage schedule ambiguous or incorrect; instructions considered average and amoxicillin wasassigned as a basis for comparison.
3. Marchant CD, Carlin SA, Johnson CE, Shurin PA. Measuring the comparative efficacy of antibacterial agents for acute otitis media: the "Pollyanna absent or incomplete phenomenon." J Pediatr. 1992;120:72-77.
Azithromycin (Zithromax, Pfizer)
Multiple drugs prescribed, resulting in confusion 4. Van Buchem FL, Dunk JH, van't Hof MA.Therapy of acute otitis media: myringotomy, antibiotics or neither? A double-blind study in children.
Figure 1. Taste
Adapted from reference 7.
5. Dowell SF, Butler J, Giebink FS, et al.Acute otitis media: management and surveillance in an era of pneumococcal resistance: a report from the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group. Pediatr Infect Dis J. 1999;18:341.
scores for selected
6. Steele RW,Thomas MP, Begue RE. Compliance issues related to the selection of antibiotic suspensions for children. Pediatr Infect Dis J. 2001;20:1-5.
7. Mattar ME, Markello J,Yaffe SJ. Pharmaceutic factors affecting pediatric compliance. Pediatrics. 1975;55:101-108.
Figure 2. Factors in failure of patients
8. Cantekin EI, Mandel EM, Bluestone CD, et al. Lack of efficacy of a decongestant–antihistamine combination for otitis media with effusion Clarithromycin (Biaxin, Abbott)
("secretory" otitis media) in children: results of a double-blind, randomized trial. N Engl J Med. 1983;308:297-301.
to comply with prescribed medication.
9. Bluestone CD. Symposium: questioning the efficacy and safety of antihistamines in the treatment of upper respiratory infection. Pediatr Infect Dis J. 1988;7:216-217.
50 mg (E)+150 mg (S) 10. Centers for Disease Control and Prevention. National, state, and urban area vaccination levels among children aged 19-35 months—United Products Division, Abbott) States, 2002. MMWR Weekly. 2003;52:728-732.
11. Eskola J, Kilpi T, Palmu A, et al. Efficacy of pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;344:403-409.
12. Omnicef (Cefdinir) for oral suspension prescribing information,Abbott Laboratories.
INDICATIONS AND SAFETY INFORMATION
Indications12: Omnicef (cefdinir) for oral suspension is indicated for mild to moderate acute bacterial otitis media and acute maxillary sinusitis (adolescent and adult) due to H
Trimethoprim (Primsol, Ascent Pediatrics)
influenzae (including ß-lactamase producing strains), S pneumoniae (penicillin-susceptible strains only), and M catarrhalis (including ß-lactamase producing strains).
Disclaimer — This educational review is designed to be a summary of information. While it is detailed, it is not an exhaustive pharma-
Well-tolerated Treatment12: The most common reported adverse events occurring in
ceutical review. McMahon Publishing Group, Abbott Laboratories, and the author neither affirm nor deny the accuracy of the informa- ≥ 1% of pediatric patients in US clinical trials (N=1783) were diarrhea (8%), rash (3%), and vomiting (1%). Two percent of 2,289 pediatric patients discontinued medication due to adverse events in US and ex-US clinical trials. Discontinuations were primarily for gas- tion contained hereon. No liability will be assumed for the use of this review, and the absence of typographical errors is not guaranteed.
8 mg (T)-40 mg (S) trointestinal disturbances, usually diarrhea. Safety and efficacy in neonates and infants less than 6 months of age have not been established. Omnicef is contraindicated in Readers are strongly urged to consult any relevant primary literature and the complete prescribing information available in the package Septra, Monarch; various) patients with a known allergy to the cephalosporin class of antibiotics. For patients with a previous hypersensitivity reaction to penicillins, caution should be exercised because insert of each drug and appropriate clinical protocols. Copyright 2003, McMahon Publishing Group, 545 West 45th Street, New York, cross-hypersensitivity among ß-lactam antibiotics has been clearly documented. If an allergic reaction to cefdinir occurs, the drug should be discontinued. Antacids that contain NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.
magnesium or aluminum and iron supplements, including multivitamins that contain iron, should be taken at least 2 hours before or 2 hours after taking Omnicef.
*Please see accompanying full prescribing information.
03I-034-9524-3 • December 2003 • Printed in USA
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