Should a patient be switched from Amoxicillin to Azithromycin for a full or partial course due to side effects occurring after the fourth day of treatment for an ear infection?

From the Guidelines

Switching a patient from Amoxicillin to Azithromycin for a full or partial course due to side effects occurring after the fourth day of treatment for an ear infection is not recommended.

Reasons for this decision

• The provided evidence 1 does not specifically address ear infections, but rather group A streptococcal pharyngitis, which may have different treatment guidelines.
• Azithromycin is recommended for a 5-day course 1 for patients with penicillin allergy, with a dose of 12 mg per kg once daily (maximum = 500 mg), but this is not directly applicable to ear infections or switching due to side effects.
• The evidence suggests that Amoxicillin is a recommended treatment for 10 days 1, and switching to Azithromycin may not be necessary unless the patient has a penicillin allergy.
• If side effects occur after the fourth day of treatment, it may be more appropriate to manage the side effects rather than switching to a different antibiotic, as the patient has already completed a significant portion of the treatment course.
• In general, completing the full course of antibiotics is important to ensure that the infection is fully cleared and to reduce the risk of antibiotic resistance.

Considerations for clinical practice

• Clinicians should weigh the benefits and risks of switching antibiotics due to side effects and consider alternative management strategies, such as managing the side effects or completing the original course of treatment.
• If a switch to Azithromycin is considered, the dose and duration should be adjusted according to the patient's weight and clinical response, as recommended in the evidence 1.

From the FDA Drug Label

For the 553 patients who were evaluated for clinical efficacy, the clinical success rate (i. e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent. In the safety analysis of the above study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9% with azithromycin and 31% with the control agent.

The patient should not be switched from Amoxicillin to Azithromycin for a full or partial course due to side effects occurring after the fourth day of treatment for an ear infection, as there is no direct information in the provided drug labels to support this decision 2.

• The studies provided compare the efficacy and safety of azithromycin and amoxicillin/clavulanate potassium, but do not address switching treatments due to side effects.
• Caution should be exercised when considering any changes to treatment, and the decision to switch should be based on a thorough evaluation of the patient's condition and medical history.
• It is essential to consider the potential benefits and risks of switching treatments, including the possibility of adverse reactions or reduced efficacy. However, the FDA drug label does not provide sufficient information to make an informed decision about switching from amoxicillin to azithromycin due to side effects.

From the Research

Switching from Amoxicillin to Azithromycin

• The decision to switch from Amoxicillin to Azithromycin due to side effects after the fourth day of treatment for an ear infection can be considered based on the efficacy and tolerability of Azithromycin compared to Amoxicillin in various studies 3, 4, 5, 6, 7.
• Studies have shown that Azithromycin can be as effective as Amoxicillin in treating ear infections, with some studies indicating that Azithromycin may result in more complete resolution of tympanic membrane disease and is better tolerated 3, 4.
• A 3-day course of Azithromycin has been shown to be as effective as a 10-day course of Amoxicillin or co-amoxiclav in treating acute otitis media and lower respiratory tract infections 3, 5, 7.
• Azithromycin has also been found to have a lower rate of adverse events compared to Amoxicillin or co-amoxiclav, with gastrointestinal disturbances being the most common side effect 3, 4, 6, 7.

Efficacy of Azithromycin

• Azithromycin has been shown to have high clinical success rates in treating ear infections, with rates ranging from 74% to 95% 3, 4, 5.
• The bacteriologic eradication rate of Azithromycin has also been found to be high, with rates ranging from 82% to 100% 4, 5, 6, 7.
• Azithromycin has been found to be effective against various pathogens, including Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis 3, 5, 7.

Tolerability of Azithromycin

• Azithromycin has been found to be well tolerated, with a lower rate of adverse events compared to Amoxicillin or co-amoxiclav 3, 4, 6, 7.
• The most common side effects of Azithromycin are gastrointestinal disturbances, which are typically mild to moderate in severity 3, 4, 6, 7.
• Azithromycin has been found to have a lower rate of discontinuation due to adverse events compared to Amoxicillin or co-amoxiclav 7.