eMedicine Specialties > Pediatrics: Surgery > Otolaryngology

Otitis Media: Treatment & Medication

Author: Muhammad Waseem, MD, Associate Professor of Emergency Medicine in Clinical Pediatrics, Weill Medical College of Cornell University; Consulting Staff, Department of Pediatrics, Bronx Lebanon Hospital; Consulting Staff, Department of Emergency Medicine, Lincoln Medical and Mental Health Center
Coauthor(s): Muhammad Aslam, MD, Instructor in Pediatrics, Harvard Medical School; Chief Clinical Fellow, Department of Newborn Medicine, Children's Hospital Boston; Leslie A Wilson, MD, Chief, Well-Baby Clinic and Chronic Ear Clinic, Department of Pediatrics, Wilford Hall Air Force Medical Center
Contributor Information and Disclosures

Updated: Jul 22, 2008

Treatment

Medical Care

Medical management of otitis media (OM) is actively debated in the medical literature, primarily because of a dramatic increase in acute OM (AOM) prevalence over the past 10 years caused by DRSP and beta-lactamase–producing H influenzae or M catarrhalis.

Beta-lactamases are enzymes that hydrolyze amoxicillin and some, but not all, oral cephalosporins, leading to in vitro resistance to these drugs. Currently, 90% of M catarrhalis isolates and 40-50% of H influenzae isolates in the United States produce beta-lactamases. As a result, empiric antibiotic therapy for this disease has become more complex. Many opinions have been expressed regarding which drugs are best for first- and second-line therapy or whether antibiotics should be prescribed in all patients with AOM.

Guidelines for medical management of AOM

In 2004, the American Academy of Pediatrics and the American Academy of Family Practice published guidelines for the medical management of AOM based on expert opinion and a thorough, nonsystematic review of the literature.¹⁰ Their recommendations are summarized as follows:

• To diagnose AOM, the clinician should confirm a history of acute onset, identify signs of MEE, and evaluate for the presence of signs and symptoms of middle-ear inflammation.
• The management of AOM should include an assessment of pain. If pain is present, the clinician should recommend treatment to reduce pain. Acetaminophen and ibuprofen are first-line drugs for pain reduction.
• OM is one of the most common disorders in children, and concern regarding antimicrobial resistance due to aggressive antibiotic use is growing. Because of these concerns, treatment of OM has significantly changed over the last decade. A growing number of physicians do not recommend antibiotic prophylaxis or treatment in children with mild OM without a fever (or with minimal fever). More importance is now given to observation and close follow-up.
• Observation without use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic certainty, age, illness severity, and assurance of follow-up. Many parents have concerns regarding this option, but education and involvement in medical decisions increases acceptability.
• Although instant access is available to clinical guidelines that recommend an expectant management for children with OM who are older than 1-2 years, the antibiotic prescription rate is still high in most emergency departments. If a decision is made to treat with an antibacterial agent, amoxicillin should be prescribed for most children. When amoxicillin is used, the dose should be 80-90 mg/kg/d.
• In vitro antibacterial activity of amoxicillin against penicillin-susceptible and nonsusceptible S pneumoniae strains isolated from children with AOM has shown that penicillin resistance cannot be extrapolated to amoxicillin. Therefore, minimal inhibitory concentrations of penicillin-nonsusceptible S pneumoniae for amoxicillin should be evaluated, and this antimicrobial agent still remains a first-line choice for children with AOM.
• If the patient fails to respond to the initial management option within 48-72 hours, the clinician must reassess the patient to confirm AOM and exclude other causes of illness. If AOM is confirmed in a patient initially treated with observation, the clinician should begin antibacterial therapy. If the patient was initially treated with one or more antibacterial agents, the clinician should change the antibacterial agent(s).
• New alternative treatments for OM are desirable because of the relatively high prevalence of recurrent and persistent AOM. The presence of the most prevalent etiologic agent, S pneumoniae, especially penicillin-nonsusceptible strains in children, also supports alternative treatment regimens.
• Large-dose cefdinir therapy can be used in combination with tympanocentesis and has high efficacy against penicillin-susceptible S pneumoniae.¹¹ The effectiveness is low for nonsusceptible and H influenzae strains.
• Clinicians should encourage the prevention of AOM through reduction of risk factors.
• Evidence is insufficient to make a recommendation regarding the use of Complementary and Alternative Medicine (CAM) for AOM.

Earlier recommendations from the American Academy of Pediatrics and the CDC working group on AOM published in 1999 are summarized as follows:

• First, distinguishing AOM from OME is critical. Prompt antibiotic therapy has been the cornerstone of therapy for AOM for decades; however, antibiotics are not indicated for initial treatment of OME.
• Second, antimicrobials should not be prescribed in patients in whom AOM is only suspected or in response to parental pressure on providers for specific therapy. A diagnosis of AOM should be supported by a careful history and physical examination that document the presence of MEE and concurrent signs or symptoms of acute illness (see History and Physical).
• Third, patients with uncomplicated AOM who are younger than 2 years should be treated with a 10-day course of antimicrobials; children older than 2 years may be treated with a 5- to 7-day course of antimicrobials. All patients with severe or recurrent AOM or with complications of AOM should be treated for a minimum of 10 days.
• Fourth, reserve antimicrobial prophylaxis for selected children with recurrent AOM. Recurrent AOM is defined as 3 or more documented episodes within the prior 6 months or 4 or more episodes in the preceding 12 months.

A meta-analysis of 6 randomized trials that studied the effects of antibiotic use in AOM showed that children older than 2 years with mild AOM can be observed without the need for antibiotic administration.¹² Antibiotic administration seemed to have a beneficial effect in patients younger than 2 years with bilateral OM and in patients with AOM and otorrhea.

A recent study determined the clinical practices related to the diagnosis of OM based on American Academy of Pediatrics guidelines.¹³ Authors reviewed 88 studies on OM diagnosis and treatment from 1994-2005. At least one American Academy of Pediatrics criteria were used in 81% of the studies, whereas 20% of the studies used all 3 criteria. Use of these criteria can help provide uniformity to the diagnosis and treatment of OM among various centers. The 2004 guidelines have also been shown to reduce the rate of antibiotic prescribing practices among primary care physicians.¹⁴

Medical therapy for AOM

In 1999, the CDC therapeutic working group on DRSP published consensus recommendations for AOM management.¹⁵ The recommendations support the use of amoxicillin as the first-line antimicrobial agent of choice in patients with AOM. The group recommended increasing the dose used for empiric treatment from 40-45 mg/kg/d to 80-90 mg/kg/d because of concerns about increasingly resistant strains of S pneumoniae, which are theoretically susceptible to this higher dose.

The recommendations for second-line therapy were more controversial, despite their reasonableness from a scientific viewpoint. Stressing the importance of documenting true clinical failure of therapy after at least 3 days of treatment with high-dose amoxicillin, the working group suggests tympanocentesis for identification and susceptibility testing of the etiologic bacteria to guide alternate antibiotic therapy. In cases in which second-line therapy is empirically chosen (a common occurrence, because few primary care physicians routinely perform tympanocentesis in the office), the recommendations suggest administering the following 3 preparations:

• High-dose amoxicillin/clavulanate (80-90 mg/kg/d of amoxicillin component, 6.4 mg/kg/d of clavulanate)
• Cefuroxime axetil
• Intramuscular (IM) ceftriaxone (administered as a single IM injection of 50 mg/kg on 3 consecutive days)

The choice of these 3 preparations from among the 16 antimicrobials currently approved by the US Food and Drug Administration (FDA) for OM therapy was based on studies that reported that these drugs achieve sufficient concentrations in middle ear fluid for bacteriocidal action against the common pathogens in AOM, including DRSP and beta-lactamase–producing H influenzae. Similar studies for the other 13 approved agents either have not been completed or failed to show similar efficacy against resistant bacteria.

These recommendations rely heavily on the pharmacodynamics model of drug efficacy. In this model, clinical cure is believed to correlate with demonstrated penetrance of the antibiotic into the middle ear at a level believed to be sufficient to kill the bacterial pathogens that cause AOM. Nevertheless, this model has the following shortcomings:

• Although bacteriologic eradication correlates with a successful clinical outcome, clinical success occurs in more than 60% of patients, even when bacteriologic eradication is not achieved. Eventually, almost all patients improve.
• Validation of the pharmacodynamic model relies on tympanocentesis to identify the causative bacteria and to measure antibiotic levels in middle ear fluid. Some antibiotics (eg, azithromycin [Zithromax], clarithromycin [Biaxin]) concentrate intracellularly, not in middle ear fluid, and are bacteriostatic, not bactericidal. A model predicated on certain drug levels and bacterial eradication may underestimate the efficacy of these agents.
• The drug levels used by the CDC to define bacterial killing were based on standards that changed 6 months after the CDC publication.

The following crucial issues in AOM treatment were not clearly addressed by the CDC recommendations:

• Patient compliance and the associated factors of dosing frequency, duration of therapy, palatability, and drug cost
• Guidance for special situations (eg, allergy to penicillins, beta-lactam drugs, or both)
• Discussion of the option of withholding antibiotic therapy for 2-3 days in a subset of patients with AOM who are likely to experience spontaneous resolution of disease with only supportive care and analgesic therapy (a widespread practice in the Netherlands and Scandinavia but a practice with few proponents in the United States)

Compliance, duration of therapy, and cost are important issues in treating children with AOM. The primary determinants of compliance appear to be frequency of dosing, palatability of the agent, and duration of therapy. Less frequent doses (ie, qd or bid) are more desirable than more frequent doses, which interfere with daily routines. Shorter duration of therapy (ie, 5-7 d vs 10-14 d) increases compliance but should be used only when equal clinical efficacy can be assured. In many instances, palatability ultimately determines compliance in children.

For children who are allergic to penicillin or beta-lactam, the only currently available products are cephalosporins, trimethoprim-sulfamethoxazole, or macrolides. Patients who are allergic to penicillin show 10-15% cross-reactivity when treated with cephalosporins. Levofloxacin has demonstrated higher efficacy in the treatment of AOM when compared with amoxicillin/clavulanate and can be used in patients who are allergic to penicillin.¹⁶

• Pneumococcal resistance to trimethoprim/sulfamethoxazole is increasing and has become more common than penicillin resistance in some areas. Use this drug to treat AOM only in regions where it remains effective.
• Of the macrolides, erythromycin/sulfisoxazole is a good choice, but many children refuse this agent because of taste; a 5-day course of azithromycin or 10-day course of clarithromycin may be preferred.
• If DRSP is the suspected etiologic bacterium, do not use macrolides because pneumococcal resistance is absolute with macrolides and, unlike the use of some beta-lactam antibiotics, resistance cannot be overcome by increasing the dose.

Many children with AOM do not benefit from antimicrobial therapy, either because the etiology of the illness is not bacterial or because their immune system clears the infection without use of a drug. No clinical criteria currently distinguish which children do not require antibiotic therapy for AOM. Until such criteria are available, many practitioners are unlikely to withhold initial antimicrobial therapy for proven cases of AOM. Increasing awareness of the pathophysiology of the disease among parents and healthcare providers has resulted in an increase in an observation-only approach in emergency departments with less parental anxiety.¹⁷

Medical therapy for OME

Most cases of OME occur after an episode of AOM, and 67% of patients develop an MEE. The mean duration of the effusions is 23 days, but many persist much longer. Most cases of OME spontaneously resolve. Studies of the natural history of this disease report the following:

• An MEE is harbored in 50% of ears 1 month after an episode of acute OME.
• An MEE is harbored in 20% of ears after 2 months.
• An MEE continues to be harbored in 10-15% of ears after 3 months.
• OMEs that persist longer than 3 months have spontaneous resolution rates of only 20-30%, even after years of observation.

Most cases of chronic OME are associated with conductive hearing loss, averaging approximately 25 dB. Complications of hearing loss (eg, language delay, behavioral problems, poor academic performance) have led to investigations of multiple medical and surgical treatments for OME. The following are among the many strategies advocated for medical treatment in patients with OME:

• Antimicrobials
• Antihistamine-decongestants
• Intranasal and systemic steroids
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Mucolytics
• Aggressive management of allergic symptoms

Of these options, only antimicrobial therapy has provided measurable benefits. Steroid therapy (when administered in combination with a beta-lactam antimicrobial) has shown benefit in some studies and no benefit in others. All other medical therapies (ie, decongestants, antihistamines, mucolytics, NSAIDs) have not provided measurable short- or long-term improvements in patients with OME.

Patients in whom OME is unresponsive to medical therapy and with an MEE that persists more than 12 weeks should be referred to an otolaryngologist to discuss surgical options in conjunction with further medical therapies.

• Antimicrobial therapy
  • No clinical guidelines or consensus recommendations suggest which antimicrobials to use as first-line agents for OME. In this era of increasing antibiotic resistance, selection of an antibiotic agent should be individualized to the patient.
  • In each patient, consider prior experience with antibiotics, age, sex, and daycare attendance.
  • If penicillin allergy is not a concern and if the patient has no recent exposure to antibiotics, a reasonable choice for initial therapy is amoxicillin, administered at the same high dose recommended by the CDC for AOM (ie, 80-90 mg/kg/d).
  • A reasonable first choice in a patient with antibiotic exposure during the prior month is trial administration of a beta-lactamase–stable agent (eg, amoxicillin/clavulanate) or a second- or third-generation cephalosporin.
  • As with antimicrobial selection, no recommendations have been made regarding duration of therapy; 10 days is reasonable for amoxicillin, amoxicillin/clavulanate, and cephalosporins. Studies of prolonged treatment in patients with OME show no advantage in therapies that last longer than 10 days.
• Steroid therapy
  • The literature on steroid treatment is inconclusive. In 1994, the Agency for Health Care Policy and Research (AHCPR) reviewed more than 5000 articles concerning the management of OME and published a clinical practice guideline on the topic.¹⁸ The review reported that a combination of steroids plus antibiotics improved clearance of MEE in 25.1% of patients. This difference did not meet statistical significance standards, and the panel felt the risks of steroid administration outweighed potential benefits. The final guideline states, "steroid medications are not recommended for treatment of OME in a child of any age."
  • Since publication of the AHCPR guideline, another investigation of steroids plus antibiotics to treat OME has been published by Rosenfeld.¹⁹ Rosenfeld reported that surgery was avoided or postponed for 6 months in 1 of 4 children treated with steroids. Therefore, steroid administration may have a role in patients who are not good surgical candidates.
  • The steroid regimen should be oral prednisone or prednisolone at a dose of 1 mg/kg/d for 5-7 days, administered in combination with a beta-lactam antibiotic.
  • Steroids are contraindicated in patients with exposure to varicella who have not received the varicella vaccine because of the possibility of life-threatening disseminated disease.

Controversy continues over the optimal management of OME. The AHCPR guideline, although criticized for having a narrow scope, for favoring medical rather than surgical management of OME, and for minimizing the problem of drug-resistant bacteria, provides a framework with which to consider management options.

Surgical Care

From the beginning, integrate surgical management of AOM and OME with medical treatment for these diseases. Early surgical interventions (eg, tympanocentesis) may be performed by primary care providers, but more invasive procedures (eg, myringotomy, TT insertion, adenoidectomy) require an otolaryngologist. In patients with intratemporal or intracranial complications of OM, surgical consultation is critical. Certain special patient populations, such as those with cleft palate, Down syndrome, or other craniofacial abnormalities, may require early surgical intervention to prevent OM.

• Indications for tympanocentesis
  • OM in patients who have severe otalgia, who are seriously ill, or who appear toxic
  • Unsatisfactory response to antimicrobial therapy
  • Onset of AOM in a patient receiving antimicrobial therapy
  • OM associated with a confirmed or potential suppurative complication
  • OM in a newborn, sick neonate, or patient who is immunologically deficient, any of whom may harbor an unusual organism
• Recommendations for TT insertion in children
  • Chronic OME: TT insertion is recommended in children in whom OME is unresponsive to a trial of antibiotic therapy and has persisted for at least 3 months, when bilateral, or at least 6 months, when unilateral. In patients with unilateral OM, 6 months of persistent OME is not an absolute indication for TT placement. If the patient has evidence of TM structural abnormality secondary to OME or if the patient has recurrent infections, TT placement is indicated. If these criteria are not met and hearing is normal in the affected ear, careful observation is probably sufficient.
  • Recurrent AOM: TT insertion is recommended in children with recurrent AOM, especially when antimicrobial prophylaxis fails. A minimum frequency of 3 or more episodes of AOM during the previous 6 months or 4 or more episodes (one of which is recent) during the previous year indicates tube insertion.
  • Recurrent OME: TT insertion is recommended in children with recurrent OME in whom the duration of each episode does not meet criteria for chronic disease but cumulative duration is considered excessive (eg, 6 of previous 12 mo).
  • ETD: TT insertion is recommended in children with ETD (even in the absence of MEE) if the child has persistent or recurrent signs and symptoms of ETD not relieved by medical treatment options or if the child has ETD at the time of reconstructive middle ear surgery. Signs and symptoms include hearing loss (usually fluctuating), disequilibrium/vertigo, tinnitus, autophony, and severe retraction pocket.
  • Barotrauma: TT insertion is recommended in children with barotrauma, especially for prevention of recurrent episodes (eg, after air travel, hypobaric chamber treatment).
• Adenoidectomy and/or tonsillectomy procedures performed to treat patients with OM (in addition to myringotomy and TT placement) have generated extensive discussion and recent research, although potential benefits are controversial. Current literature supports the following recommendations from Bluestone:²⁰
  • Initial surgery: Myringotomy and TT placement are the initial surgical techniques (withhold adenoidectomy unless the patient has a nasal obstruction). Some experts advocate simultaneous adenoidectomy in patients older than 3 years because this has been shown to improve ET function.
  • Repeat surgery (following extrusion of tubes and recurrence of chronic MEE unresponsive to antimicrobial therapy): Myringotomy, with or without tube placement, and adenoidectomy, irrespective of adenoid size, are the techniques used.
  • Tonsillectomy: Although it is not indicated for treatment of OM because it has not been shown to benefit ET function, tonsillectomy may be performed concurrently with surgery for OM if indications are present (eg, frequently recurrent tonsillitis, pharyngeal obstruction).
• Recommendations for surgery in patients with cleft palate, Down syndrome, and other craniofacial abnormalities include the following:
  • Myringotomy and TT placement are warranted in most children with cleft palate because of inherent ETD and increased risk of OM. In patients who also have a cleft lip, the TT may be placed at the time of initial lip repair, many months prior to palate repair. Consider performing TT placement or replacement at the time of palate repair.
  • Children with Down syndrome often exhibit ETD, conductive and sensorineural hearing loss, EAC stenosis, and subtle immunologic deficiencies. These conditions create a high risk for OM, make diagnosis of MEE difficult, and can lead to profound language and learning difficulties.
    • The essential elements of care in these patients include close monitoring, appropriate surgical interventions for EAC enlargement, and repetitive TT placements.
    • Tube selection is a critical issue. These patients may require prolonged external ventilation with TTs because of prolonged ETD. Unfortunately, TTs labeled as long acting or permanent cause the greatest damage to the TM.
    • These patients often require repeated TT insertions, even when long-acting or permanent TTs are used.
    • The best procedure may be to anticipate early extrusion and reinsertion and to avoid these tubes in favor of ultrasmall TTs to prevent long-term TM damage.

Consultations

• Otolaryngologist: Refer all patients who may require surgical interventions for complicated OM or who have recurrent AOM or chronic OME to an otolaryngologist. Primary care physicians who are uncomfortable performing tympanocentesis should refer patients who need this procedure to an otolaryngologist.
• Otologist: Children who present with subjective evidence of hearing loss should receive a formal hearing test (ie, audiogram). Subjective evidence of hearing loss is often provided by a parent or caregiver in younger children or, possibly, by a school teacher in older children.
• Speech therapist: Speech therapy is indicated for patients in whom COM has caused speech and language delays because of hearing loss.
  

Medication

The FDA has approved more than a dozen antibiotics to treat otitis media (OM).

Some clinicians advocate administering corticosteroids in combination with a beta-lactam–stable antibiotic. Before prescribing such therapy, obtain a history of varicella, vaccination against varicella, and recent exposure to a patient with varicella to avoid the risk of disseminated varicella.

Studies of other adjunctive therapy for acute OM (AOM) and OME have shown that NSAIDs, decongestants, and antihistamines provide no obvious benefits.

Antimicrobial agents

These agents remove pathogenic bacteria from middle ear fluid.

Amoxicillin (Biomox, Amoxil, Trimox)

Mainly bactericidal. As with penicillins, inhibits third and final stage of bacterial cell wall synthesis by preferentially binding to specific PBPs located inside the bacterial cell wall.
PO semisynthetic aminopenicillin similar to ampicillin. Aminopenicillins are not stable in beta-lactamases of either gram-positive or gram-negative bacteria; more stable in gastric acid than penicillin and more bioavailable than PO ampicillin.
Amoxicillin is associated with a lower prevalence of diarrhea than is ampicillin administered PO because of the greater bioavailability of amoxicillin. Commonly used to treat infections (eg, OM, bronchitis, sinusitis, bacterial cystitis) caused by susceptible organisms. To increase efficacy against PRSP in OM or respiratory infections, higher dosing regimens have been recommended.

Amoxicillin and clavulanate (Augmentin)

As a beta-lactam antibiotic, amoxicillin is mainly bactericidal. Inhibits third and final stage of bacterial cell wall synthesis by preferentially binding to specific PBPs located inside the bacterial cell wall. As with all beta-lactam antibiotics, ability to interfere with PBP-mediated cell wall synthesis ultimately leads to cell lysis.
Clavulanic acid is a beta-lactamase inhibitor that possesses weak antibacterial activity and acts as a competitive "suicide" inhibitor of many plasmid-mediated and chromosome-mediated bacterial beta-lactamases.
Excellent choice for second-line therapy in AOM or initial therapy in OME. Drug combination treats bacteria resistant to beta-lactam antibiotics. Combination with clavulanic acid reestablishes amoxicillin's activity against beta-lactamase-producing bacteria. Excellent for treating infections due to beta-lactamase-producing H influenzae and penicillinase-producing anaerobes.
Commonly used to treat infections (eg, AOM, acute sinusitis, acute bacterial cystitis, uncomplicated gonorrhea, chancroid) caused by susceptible organisms.
For children >3 mo, base dosing protocol on amoxicillin content. Because of different amoxicillin/clavulanic acid ratios in 250-mg tab (250/125) vs 250-mg chewable tab (250/62.5), do not use 250-mg tab until child weighs >40 kg. Use the 7:1 formulation (ie, bid formulation) in higher doses to minimize GI tract effects.

Cefaclor (Ceclor)

Second-generation PO cephalosporin indicated for infections caused by susceptible gram-positive cocci and gram-negative rods. Has slightly improved activity against H influenzae compared to cephalexin. Although marketed after first-generation agents, causing some clinicians to consider it a second-generation agent, its spectrum more closely resembles first-generation cephalosporins. Clinically, used primarily to treat OM, sinusitis, and URIs caused by H influenzae that are resistant to ampicillin or amoxicillin.
Use higher doses for severe infections (eg, pneumonia, OM), less susceptible strains of pathogens, and in patients who are obese.

Cefprozil (Cefzil)

PO, semisynthetic, second-generation cephalosporin. Binds to one or more PBPs, which, in turn, inhibit cell wall synthesis and result in bactericidal activity. Possible second-line therapy for AOM or initial therapy for OME. Therapeutic uses include OM, soft tissue infections, and respiratory tract infections.

Cefuroxime (Ceftin)

Second-generation cephalosporin maintains the gram-positive activity of first-generation cephalosporins and adds activity against Proteus mirabilis, H influenzae, E coli, K pneumoniae, and M catarrhalis.
Common clinical uses include severe upper and lower respiratory tract infections, skin infections, OM, and surgical prophylaxis.
Condition of patient, severity of infection, and susceptibility of microorganism determine proper dose and route of administration. Susp is less bioavailable than tab. Bioavailability is enhanced when administered with food or infant formula.

Cefixime (Suprax)

Third-generation cephalosporin available in an PO formulation. As with ceftriaxone, has enhanced antibacterial activity and increased stability against many beta-lactamases. By binding to one or more PBPs, it arrests bacterial cell wall synthesis and inhibits bacterial growth.
Commonly used to treat OM, respiratory tract infections, and URIs caused by susceptible organisms.
When treating OM, susp is preferred due to higher serum concentrations achieved with this dosage form compared with tabs.

Ceftriaxone (Rocephin)

Third-generation cephalosporin with broad-spectrum gram-negative activity; lower efficacy against gram-positive organisms; higher efficacy against resistant organisms. Arrests bacterial growth by binding to one or more PBPs. Has longest half-life of all cephalosporins, allowing once-daily dosing and making it a useful antibiotic for outpatient therapy.
In Dec 1997, the FDA approved IM ceftriaxone to treat bacterial AOM caused by H influenzae (beta-lactamase negative), H influenzae (beta-lactamase positive), M catarrhalis (including beta-lactamase producing strains), and S pneumoniae. Approval was based on the following data in children aged 5 months to 5 years: A prospective, randomized, double-blind, clinical trial compared the effectiveness of a 50 mg/kg single dose of IM ceftriaxone (n=116) with a 10-d course of PO amoxicillin (n=117). The authors concluded that a single IM injection of ceftriaxone is as effective as PO amoxicillin to treat uncomplicated OM in children.
The CDC's DRSP therapeutic working group suggests this dose for 3 consecutive days in cases of suspected resistant bacteria.

Cefpodoxime (Vantin)

Cefpodoxime proxetil is an PO prodrug for the extended-spectrum, semisynthetic, cephalosporin antibiotic cefpodoxime. Spectrum is similar to third-generation cephalosporins and primarily has gram-negative coverage but also covers some gram-positive organisms. Highly stable in the presence of beta-lactamase enzymes; as a result, many organisms resistant to penicillins and some cephalosporins (due to beta-lactamases) may be susceptible to cefpodoxime.
Indicated for treatment of upper and lower respiratory tract infections, UTIs, STDs, and skin and skin structure infections. Has long half-life, allowing twice-daily administration. Approved by the FDA in 1984.

Clarithromycin (Biaxin)

PO macrolide antibiotic similar to erythromycin and azithromycin. Commonly used in infections of the respiratory tract, STDs, OM, and infections in patients with AIDS. As with other macrolides, binds to 50S subunit of the 70S ribosome, thereby blocking RNA-mediated bacterial protein synthesis. Can be bacteriostatic or bactericidal in action, depending on concentration and the particular organism and its inoculum. Also penetrates phagocytes and macrophages efficiently, and, as a result, is effective against a wide variety of organisms in respiratory infections.
Generally active against organisms that are usually susceptible to erythromycin, including most staphylococcal and streptococcal strains. In addition, clarithromycin is active against M catarrhalis, Mycoplasma pneumoniae, Legionella species, and Chlamydia pneumoniae. Beta-lactamase production should have no effect on activity. Most strains of methicillin-resistant and oxacillin-resistant staphylococci are resistant to clarithromycin.
Originally approved by the FDA in Oct 1991.

Azithromycin (Zithromax)

Semisynthetic antibiotic belonging to the macrolide subgroup of azalides. Similar in structure to erythromycin. Inhibits protein synthesis in bacterial cells by binding to the 50S subunit of bacterial ribosomes. Action is generally bacteriostatic but can be bactericidal in high concentrations or against susceptible organisms.
Although significantly more expensive, it can be administered as a once-daily dose and produces less GI tract intolerance than erythromycin. Apparent advantage over erythromycin is that it reaches higher intracellular concentrations, thus increasing efficacy and duration of action. These advantages are demonstrated in studies that show that single doses are effective for the treatment of STDs caused by chlamydial and gonorrheal organisms.
Approved by FDA in Nov 1991. PO susp was introduced in Apr 1995. In late 1995, was approved for treatment of pediatric OM and pharyngitis and, in mid 1996, was approved for MAC prophylaxis in patients with advanced HIV disease.
IV form is also available for initial treatment of community-acquired pneumonia and pelvic inflammatory disease.

Trimethoprim and sulfamethoxazole (Bactrim DS, Septra DS)

Also known as co-trimoxazole. Combination product of TMP and SMZ in a fixed 1:5 ratio. Ratio produces serum concentrations of 1:20, which optimize antibacterial activity against some organisms. Both TMP and SMZ are synthetic folate antagonists that are effective antimicrobials as individual agents. TMP is usually bactericidal and acts by inhibiting sequential enzymes of the folic acid–synthesis pathway. SMZ is a structural analog of PABA and competitively inhibits formation of dihydrofolic acid from PABA. TMP binds to and reversibly inhibits the enzyme dihydrofolate reductase, which prevents formation of THF from dihydrofolic acid.
THF is a metabolically active form of folic acid. Without THF, bacteria cannot synthesize thymidine, which leads to interference with bacterial nucleic acid and protein formation.
Combination of TMP with SMZ is synergistic against some bacteria. Usually active against Staphylococcus epidermidis, S aureus, S pneumoniae, Streptococcus viridans, most Enterobacteriaceae, Salmonella and Shigella species, H influenzae, M catarrhalis, and Stenotrophomonas maltophilia. Enterococcus species, Neisseria gonorrhoeae, P aeruginosa, and anaerobes are usually resistant or less susceptible. Also effective against Pneumocystis carinii, Listeria monocytogenes, many Nocardia species, Yersinia enterocolitica, and Legionella pneumophila.
Initially used in the treatment of UTIs but has since proved to be a versatile agent and is now widely used in the prevention and treatment of P carinii pneumonia. Approved by FDA in 1973.

Erythromycin (E-Mycin, Eryc, Ery-Tab, Erythrocin)

Macrolide antibiotic produced by Streptomyces erythraeus; first of several macrolide antibiotics now on the market.
Inhibits bacterial growth, possibly by blocking dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest. For treatment of staphylococcal and streptococcal infections. Effective against wide range of microorganisms and, as with other antibiotics that inhibit protein synthesis, is mainly bacteriostatic.
Activity against gram-positive organisms is usually greater than against gram-negative organisms because of superior penetration into gram-positive organisms.
Gram-positive organisms susceptible to erythromycin include S aureus, Streptococcus agalactiae, Streptococcus pyogenes, S pneumoniae, S viridans, and Corynebacterium diphtheriae. Gram-negative coverage is limited. In general, should not be used against H influenzae, although, in some cases, organism may be susceptible. Although erythromycin is active against many microbes, its clinical applications are relatively few.
In children, age, weight, and severity of infection determine proper dosage. When bid dosing is desired, half of the total daily dose may be taken q12h. For more severe infections, double the dose.

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