What is the treatment for ear infections in children, specifically using Augmentin (amoxicillin/clavulanic acid)?

From the Guidelines

Augmentin 625 suspension is an effective treatment for ear infections in children, particularly for acute otitis media that is severe or when there are concerns about antibiotic resistance. The typical dosage for children is 90 mg/kg/day of the amoxicillin component, divided into two doses given every 12 hours for 5-10 days 1. For most uncomplicated ear infections, a 5-day course is sufficient for children over 2 years old, while younger children or those with severe infections may need the full 10-day treatment.

Key Considerations

• The medication comes in various formulations including liquid suspensions of different strengths (200 mg/5mL, 400 mg/5mL, or 600 mg/5mL), which should be refrigerated after reconstitution and shaken well before each dose.
• Common side effects include diarrhea, diaper rash, and nausea.
• It's essential to complete the full prescribed course even if symptoms improve quickly, as stopping early can lead to recurrence or antibiotic resistance.
• Augmentin works by combining amoxicillin, which kills bacteria by disrupting cell wall formation, with clavulanic acid, which prevents bacteria from inactivating the amoxicillin through beta-lactamase enzymes.
• Pain relievers like acetaminophen or ibuprofen can be given alongside antibiotics to manage ear pain while waiting for the infection to clear.

Treatment Failure

If the patient is not improved by 48 to 72 hours, another disease or concomitant viral infection may be present, or the causative bacteria may be resistant to the chosen therapy 1. In such cases, the clinician may consider changing the antibiotic. If the child was initially treated with amoxicillin and failed to improve, amoxicillin-clavulanate should be used. Patients who were given amoxicillin-clavulanate or oral third-generation cephalosporins may receive intramuscular ceftriaxone (50 mg/kg).

Important Notes

• The American Academy of Pediatrics recommends amoxicillin alone or in combination with clavulanate as the first-line antibiotic choice for acute bacterial sinusitis in children 1.
• The choice of antibiotic and duration of treatment should be based on the severity of the infection, the patient's age, and the presence of any underlying medical conditions.
• It's crucial to follow the prescribed treatment plan and complete the full course of antibiotics to ensure effective treatment and prevent antibiotic resistance.

From the FDA Drug Label

Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcusspecies. (α-and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae.

The Augmentin 625 suspension is effective for treating ear infections in kids caused by susceptible bacteria, specifically Streptococcus pneumoniae and Haemophilus influenzae. However, it is essential to note that the treatment should only be used when the infection is proven or strongly suspected to be caused by bacteria.

• The dosage and administration instructions should be followed carefully to minimize gastrointestinal intolerance.
• Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained 2.

From the Research

Effectiveness of Augmentin 625 Suspension for Kids with Ear Infections

• Augmentin (amoxicillin/clavulanic acid) is a well-established broad-spectrum antibacterial treatment effective and well-tolerated in the treatment of acute otitis media (AOM) in pediatric patients 3.
• The high-dose formulation of amoxicillin/clavulanic acid (90/6.4 mg/kg/day in two divided doses) has been shown to eradicate a high proportion of penicillin-resistant Streptococcus pneumoniae in children with AOM 3.
• Studies have compared the efficacy of amoxicillin/clavulanic acid with other antimicrobial agents, such as azithromycin, cefdinir, and cefaclor, in the treatment of AOM in children, with varying results 4, 5, 6.
• A systematic review found that amoxicillin-clavulanate was superior to azithromycin, cefdinir, placebo, cefaclor, and penicillin V in five out of 12 randomized controlled trials, while its efficacy was comparable to other antimicrobials or placebo in seven trials 5.
• Another study found that 10 days of high-dose amoxicillin/clavulanic acid was significantly more effective than 5 days of cefdinir in the treatment of AOM in children aged 6-24 months 6.

Treatment Outcomes and Comparisons

• The clinical response rates of amoxicillin/clavulanic acid were similar to those of oral cephalosporin comparators and similar to or significantly greater than those for intramuscular ceftriaxone in randomized trials in pediatric patients with AOM 3.
• A study found that azithromycin treatment for three days was faster and more effective clinically and analytically than standard treatment with amoxicillin/clavulanic acid or cefaclor in acute infections of the ear, nose, and throat 4.
• A review of short-course antibiotics for AOM found that five days of short-acting antibiotic was effective treatment for uncomplicated ear infections in children, with comparable outcomes to longer courses of antibiotics 7.

Safety and Tolerability

• Amoxicillin/clavulanic acid is generally well-tolerated, with a low total incidence of adverse events (3.6%) and no serious events reported in a large pediatric postmarketing study 3.
• The most frequently reported adverse events in children are mild gastrointestinal disturbances, with diarrhea being less frequent with twice-daily than with three-times-daily treatment 3.