Rx Update: April 1999

Acute Otitis Media: Consensus Report From CDC

Mary Ross, R.Ph., M.B.A.
Peer Review Status: Internally Reviewed


An expert group was convened by the CDC to develop consensus guidelines for the treatment and surveillance of otitis media in the growing era of drug-resistant Streptococcus pneumoniae (DRSP).

Streptococcus pneumoniae is the most important cause of otitis media because it causes the largest proportion of cases (40%) and it is the least likely of the common pathogens (S. pneumoniae, H. influenza, M. catarrhalis) to resolve without treatment. The recent emergence of multiple DRSP in the US has complicated empiric treatment and led to increased treatment failures.

Amoxicillin remains the initial drug of choice for first line treatment of uncomplicated otitis media. It is the best oral antibiotic in clinical use for treating DRSP. It is highly effective against pneumococci and displays the best pharmacodynamic profile against DRSP of any of the commonly available oral agents. The standard recommended doses (40 to 45 mg/kg/day) achieves peak middle ear fluid concentrations that may be expected to fail to eradicate DRSP in some cases. Higher doses of amoxicillin (80 to 90 mg/kg/day) have been shown to provide superior middle ear fluid concentrations to eradicate DRSP. It is recommended that high dose amoxicillin be used for first line therapy in high risk patients. Patients at low risk for DRSP may be appropriately treated with amoxicillin (40 to 50 mg/kg/day). Low risk patients are considered those older than 2 years of age without recent antimicrobial exposure in the last 3 months, and no daycare attendance.

At present there is no single oral antibiotic that eradicates all otitis media pathogens Treatment failures can be defined by lack of clinical improvement in signs and symptoms such as ear pain, fever, and tympanic membrance findings of redness, bulging or otorrhea after 3 days of therapy. In case of treatment failures, alternative agents should be effective against beta-lactamase-producing H. influenzae and M. catarrhalis and they should be effective against S. pneumoniae, including most DRSP. Agents that would meet this criteria and would be appropriate alternative therapy include amoxicillin-clavulanate given in higher dose (80 to 90 mg/kg/day), cefuroxime, and intramuscular ceftriaxone (especially if given for 3 days vs. 1 day of therapy). Cefprozil and cefpodoxime cannot yet be endorsed as alternative agents because of limited evidence for efficacy against DRSP in clinical trials. Trimethoprim/sulfamethoxazole (TMP/SMZ) and macrolides have been traditionally used as first and second line agents for otitis media, but they can no longer be used because the resistance to TMP/SMZ and macrolides in substantial. A second possibility for alternative treatment is clindamycin.

Acute Otitis Media Guidelines for Children
Antibiotics in Prior Month Day 0 Clinically Defined Treatment Failure on Day 3 Clinically Defined Treatment Failure on Days 10 to 28
No

High dose amoxicillin or usual dose amoxicillin

High dose amoxicillin-clavulanate, cefuroxime, or IM ceftriaxone

Same as Day 3

Yes

High dose amoxicillin, high dose amoxicillin-clavulanate, or cefuroxime

IM ceftriaxone, clinidamycin, or tympanocentesis

High dose amoxicillin-clavulante, cefuroxime, IM ceftriaxone, or tympanocentesis


Lymphocyte Immune Globulin Comparison
Anti-thymocyte globulin
(RABBIT)(Thymoglobulin®) was recently added to the Formulary for the treatment of acute renal graft rejection. This has a very similar name and indications for use as lymphocyte immune globulin, anti-thymocyte globulin (EQUINE) (Atgam®) which is indicated for the treatment/prophylaxis of acute renal graft rejection and aplastic anemia.

The recommended dose for Thymoglobulin® is 1.5 mg/kg/day for 7 to 14 days. The recommended dose for Atgam® for the treatment of acute renal graft rejection is 10 to 15 mg/kg/day for 14 days. Administration guidlelines are similar for both products.

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