Otitis media: Antibiotics for Ear Infection
Updated according to 2013 AAP Clinical Practice Guidelines for The Diagnosis and Management of Acute Otitis Media.
- Next to the common cold, ear infections are the most commonly diagnosed childhood illness in the United States.
- About 75% of children experience at least one episode of ear infection by age of 3 years.
- Although otitis media is primarily a disease of infants and young children, it can also affect adults.
Otitis media is an inflammation of the middle ear. This inflammation often begins when the infection that causes respiratory illness spreads to the middle ear.
Acute otitis media is a short-term ear infection with sudden onset of signs and symptoms of middle-ear effusion and inflammation.
Chronic otitis media is when ear infections keep coming back or one infection lasts for a very long time. It often has less severe symptoms so the infection may be unnoticed and untreated for a long time, which means it can cause more damage than an acute infection.
Otitis media with effusion (OME) is fluid in the middle ear without signs or symptoms of infection. Unlike children with an acute ear infection, children with OME do not act sick. Otitis media with effusion usually goes away on its own over weeks or months.
Cells in the middle ear make a fluid that normally drains out through the eustachian tube and into the throat. But if the eustachian tube (the passage that connects the back of the nose to the middle ear) becomes swollen, the fluid can become trapped in the middle ear, forming a breeding ground for bacteria that can cause the area to become inflamed and infected. Children are at greater risk of ear infection than adults because of the small size and horizontal position of their eustachian tube.
Bacteria and viruses can cause middle ear infection. Bacteria such as Streptococcus pneumoniae (pneumococcus), nontypable Hemophilus influenzae and Moraxella catarrhalis account for about 85% of cases of acute otitis media. Viruses account for the remaining 15%.
The most common symptoms of Acute otitis media are:
- severe ear ache, due to the pressure of the mucus on the eardrum
- flu-like symptoms in children, such as vomiting and lethargy
- hearing difficulties
Chronic otitis media often has fewer and milder symptoms. However, the illness goes on for a long time or keeps coming back. There is also more likely to be pus or fluid coming out of the ear.
Otitis media is often difficult to detect because most young children do not yet have sufficient speech and language skills to tell someone what is bothering them. Common signs to look for are:
- unusual irritability
- difficulty sleeping
- tugging or pulling at one or both ears
- fluid draining from the ear
- not respond to soft sounds
- turn up the television or radio
- talk louder
Not all forms of otitis need to be treated with antibiotics. It is important to distinguish Acute otitis media, which may benefit modestly from antibiotics, from Otitis media with effusion, which does not. In otitis media with effusion (OME) antibiotics may help if the fluid is still present after a few months and is causing hearing problems in both ears.
Many children do not benefit from antibiotics because their illness is not caused by bacterial infection or the infection is cleared by the immune system.
The decision to prescribe antibiotics depends on the child's age, the certainty of the diagnosis and the severity of symptoms.
The use of prophylactic antibiotics to prevent recurrent otitis media is controversial. Current AAP Practice Guidelines don't recommend prophylactic antibiotics to reduce the frequency of episodes of AOM.
Decongestants and antihistamines are not effective in the treatment of acute otitis media, and they may cause complications.
Currently, there are 19 antimicrobial agents approved by the U.S. FDA for the treatment of ear infection. The preferred antibiotic must be active against Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis.
Children with ear infection with high temperature and vomiting are more likely to benefit from immediate treatment with antibiotics. Children who don't have high fever and vomiting are unlikely to have complications and unlikely to benefit from immediate antibiotics4.
There are situations when antibiotics should be given promptly:
- Child has moderate or severe ear pain (otalgia).
- Child has a high fever (more than 102°F or 38.89°C).
- Child is dehydrated.
- Child has serious chronic conditions, such as heart disease or cystic fibrosis, that could put him or her at risk for complications from an ear infection.
- Child younger than 2 years of age, because the risk of complications is higher for very young children.
- Child worsens or fails to improve within 48 to 72 hours of onset of symptoms.
About 80% of children with ear infection get better without antibiotics. And children whose ear infections are not treated immediately with drugs are not likely to develop a serious illness. Therefore it is better to wait and give antibiotics only if they are needed.
Parents may be advised to wait 48 to 72 hours to see whether the ear infection clears on its own1.
If after 48 hours your child is not improved and needs antibiotics, you may have to wait at least another 48 hours for antibacterial medication to take effect.
Amoxicillin is the mainstay of treatment for ear infections. 2013 updated American Academy of Pediatrics Treatment Guidelines support the selection of amoxicillin as a first-line therapy.
Amoxicillin is the best antibiotic for ear infection because of high effectiveness, safety, favorable taste, and reasonable cost. Amoxicillin is active against all bacterial pathogens causing acute otitis media. It is effective even in populations with certain highly resistant bacteria.
The length of treatment is 10 days for younger children and people with severe illness, and 5- to 7-day course is recommended for children older than 6 years.
Pediatric dosage recommended by 2013 AAP guideline6
- 80 to 90 mg/kg per day in 2 divided doses.
Amoxicillin dosage according to the prescribing information10:
For mild or moderate ear infections, the usual dose is 25 mg per 2.2 pounds of body weight, divided into two daily doses and taken every 12 hours; or 20 mg per 2.2 pounds of body weight, divided into three daily doses and taken every 8 hours.
For severe infections: 45 mg per 2.2 pounds of body weight, divided into two daily doses and taken every 12 hours; or 40 mg per 2.2 pounds of body weight, divided into three daily doses and taken every 8 hours.
Children weighing 88 pounds and over should follow the recommended adult dose schedule.
- Adults: For mild or moderate infections, the usual dose is 250 mg every 8 hours, or 500 mg every 12 hours.
For severe infections: 500 mg every 8 hours, or 875 mg every 12 hours.
Indications for using another (second-line) antibiotic include 6:
- failure to respond to initial treatment (resistant or persistent acute otitis media)
- history of recurrent acute otitis media unresponsive to amoxicillin
- hypersensitivity -- allergy to penicillins
- presence of resistant organism determined by culture
- coexisting illness requiring a different medication, e.g. concurrent purulent conjunctivitis
- child received amoxicillin within last 30 days.
Amoxicillin-clavulanate is the treatment of choice for children with severe symptoms. If the child with the ear infection has a fever over 102.2 F (39°C) or is severely ill, then the best starting antibiotic is Amoxicillin/Clavulanate, according to the American Academy of Pediatrics (AAP)/American Academy of Family Physicians (AAFP) guidelines6.
Also, when initial amoxicillin treatment fails, all guidelines recommend high-dose amoxicillin/clavulanate as a preferred second-line choice6.
The addition of clavulanate to amoxicillin provides the additional activity against beta-lactamase-producing bacteria.
Amoxicillin/clavulanate frequently causes gastrointestinal side effects, such as diarrhea. It may be quite problematic in very sick children, who often refuse to eat or drink enough milk to protect their gastrointestinal tracts from the distress of medication on an empty stomach.
Amoxicillin/clavulanate suspension tastes worse than other antibiotics.
Pediatric dosagerecommended by 2013 AAP guideline6
- 90 mg/kg per day of amoxicillin, with 6.4 mg/kg per day of clavulanate (amoxicillin to clavulanate ratio 14:1) in 2 divided doses
Amoxicillin-clavulanate dosage according to the prescribing information11:
Children weighing 88 pounds or more are usually prescribed the adult dosage.
Children less than 3 months: 30 mg per 2.2 pounds of body weight per day, divided into 2 doses and taken every 12 hours.
Older than 3 months: the usual dose of the 200- or 400-milligram suspension is 45 mg per 2.2 pounds per day, in 2 doses, every 12 hours, and of the 125- or 250-milligram suspension, 40 mg per 2.2 pounds per day, in 3 doses, every 8 hours
The usual adult dose is 500 mg every 12 hours or 250 mg every 8 hours.
For severe condition: 875 mg every 12 hours or 500 mg every 8 hours.
TMP-SMX (Bactrim) is bactericidal against all the middle ear pathogens H. influenzae, S. pneumoniae, staphylococci and streptococci. Acute ear infections and chronic active otitis media7 respond well to treatment with trimethoprim-sulfamethoxazole. Moreover, it is safe for children.
According to the new Guidelines 6 TMP/SMX is considered an inferior option because of the high rate of pneumococcal resistance.
TMP-SMX (Bactrim) dosage:
- Adults: 160 mg of trimethoprim and 800 mg of sulfamethoxazole every 12 hours for 10 to 14 days.
- Children: 8 mg/kg of trimethoprim and 40 mg/kg of sulfamethoxazole every 12 hours for 10 days.
Cefuroxime is considered a second-line choice for the treatment of ear infection, when amoxicillin or amoxicillin/clavulanate are ineffective or cannot be used.
Cefuroxime can be prescribed in penicillin-allergic children (Type I reaction), as this antibiotic possesses differing chemical side chains.
Results of controlled clinical studies5 in children 3 months to 12 years of age with AOM show that a 10-day course of cefuroxime is as effective or more effective than a 10-day course of cefaclor, amoxicillin, or amoxicillin/clavulanate potassium. Cefuroxime axetil treatment provides cure or improvement rate of 70-86% in children with ear infection8.
Research shows, that short-term 5-day course of Cefuroxime is also effective8. However, some doctors caution that short-term antibiotic regimens (i.e., 5 days or less) may not be appropriate for the treatment of ear infections in children younger than 2 years of age or for persons with underlying disease, recurrent or persistent otitis media, or perforated tympanic membranes and spontaneous purulent drainage.
Oral suspension may be given to children ranging in age from 3 months to 12 years.
Your doctor will determine the dosage based on child's weight and the type of infection. Ceftin oral suspension is given twice a day for 10 days. The maximum daily dose ranges from 500 to 1000 mg. For children who are able to swallow tablets whole, the usual dosage for ear infection is 250 mg 2 times a day for 10 days.
The usual dose for adults and children 13 years and older is 250 mg, 2 times a day for up to 10 days. For more severe infections 500 mg twice per day.
Cefpodoxime is one of the recommended agents for second line choice. Cefpodoxime is effective against both pneumococci and beta-lactamase producing organisms.
The most frequent side effects are gastrointestinal and dermatological.
Cefpodoxime can be prescribed in penicillin- or amoxicillin-allergic children (Type I reaction), as this antibiotic possesses differing chemical side chains.
Cefpodoxime proxetil (Vantin) dosage:
Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5 days. Maximum 200 mg every 12 hours for children 2 months to 12 years of age.
100 to 400 mg every 12 hours.
Cefdinir is a possible second line choice. The advantages of cefdinir (Omnicef) include pleasant taste, once- or twice- per day dosing, and a 5-day course for acute ear infection treatment.
Cefdinir also can be prescribed in penicillin- or amoxicillin-allergic children (Type I reaction).
Cefdinir (Omnicef) dosage:
7 mg per 2.2 pounds every 12 hours for 5 to 10 days or 14 mg per 2.2 pounds once a day for 10 days.
300 mg every 12 hours for 5 to 10 days or 600 mg once a day for 10 days.
Ceftriaxone (Rocephin) is typically reserved as an antibiotic of last resort, due to the increased expense, inconvenience, onerousness, and rare risk for anaphylaxis.
Ceftriaxone is injected intramuscularly. It may be a right choice for children who have vomiting or other conditions that hamper oral administration.
Ceftriaxone provides excellent antibacterial activity against the major Otitis media pathogens: S. pneumoniae, H. influenzae, and M. catarrhalis.
Azithromycin or clarithromycin are not perfect options for otitis media, however they are preferred for patients with severe penicillin allergy. Azithromycin and clarithromycin concentrate intracellularly, not in the middle ear fluid, and are bacteriostatic, not bactericidal.
Although azithromycin is a very convenient antibiotic, it does not provide as good antibacterial activity against relevant pathogens. Its activity toward lactamase producing strains of Hemophilus influenzae and Moraxella catarrhalis is low. The current pediatric guidelines endorse azithromycin (and clarithromycin) for the treatment of AOM only when the patient has an anaphylactic allergy to penicillin.
Topical fluoroquinolones -- ofloxacin otic and ciprofloxacin/dexamethasone otic (Ciprodex) -- are effective in patients with tympanostomy tubes and or who suffer acute otorrhea 9.
- 1. Otitis Media (Ear Infection) National Institute on Deafness and Other Communication Disorders.
- 2. Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. Sep 2006;296:1235-1241.
- 3. Otitis Media on eMedicine
- 4. Little P, Gould C, Moore M, Warner G, Dunleavey J, Williamson I. Predictors of poor outcome and benefits from antibiotics in children with acute otitis media: pragmatic randomised trial. BMJ. 2002 Jul 6;325(7354):22
- 5. Pichichero M, Aronovitz GH, Gooch WM, McLinn SE, Maddern B, Johnson C, Darden PM. Comparison of cefuroxime, cefaclor, and amoxicillin-clavulanate potassium suspensions in acute otitis media in infants and children. South Med J. 1990 Oct;83(10):1174-7.
- 6. American Academy of Pediatrics Clinical Practice Guideline. The Diagnosis and Management of Acute Otitis Media. Pediatrics. February 25, 2013 A
- 7. van der Veen EL, Rovers MM, Albers FW, Sanders EA, Schilder AG. Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial. Pediatrics. 2007 May;119(5):897-904.
- 8. Gooch WM 3rd, Blair E, Puopolo A, Paster RZ, Schwartz RH, Miller HC, Smyre HL, Yetman R, Giguere GG, Collins JJ. Effectiveness of five days of therapy with cefuroxime axetil suspension for treatment of acute otitis media. Pediatr Infect Dis J. 1996 Feb;15(2):157-64. PubMed
- 9. Goldblatt EL . Efficacy of ofloxacin and other otic preparations for acute otitis media in patients with tympanostomy tubes. Pediatr Infect Dis J. 2001 Jan;20(1):116-9
- 10. Amoxil® prescribing information PDF
- 11. Augmentin® prescribing information PDF
Published: July, 2010
Last updated: December 26, 2016