amoxicillin
Regulatory sources consulted
Approved indications
- Susceptible respiratory, ear-nose-throat, urinary, and dental infections, Lyme disease, typhoid/paratyphoid fever, H. pylori eradication, and endocarditis prophylaxis.
Contraindications
Absolute
- Hypersensitivity to amoxicillin or a history of a severe immediate hypersensitivity reaction to another beta-lactam.
Clinical warnings
- Major warning · It may cause severe hypersensitivity or anaphylaxis. Review any history of immediate beta-lactam reactions before use and discontinue if an allergic reaction occurs. — CIMA/AEMPS, ficha técnica 62880
- Major warning · It may cause Clostridioides difficile-associated diarrhea during or after treatment; assess significant diarrhea and avoid antiperistaltic drugs if colitis is suspected. — CIMA/AEMPS, ficha técnica 62880
Drug interactions
- HighOral anticoagulants
Mechanism: The antibiotic and infection may increase INR or bleeding risk.
Recommendation: Monitor INR and bleeding during and shortly after treatment.
CIMA/AEMPS, ficha técnica 62880
- ModerateProbenecid
Mechanism: It reduces renal tubular secretion and may increase and prolong antibiotic exposure.
Recommendation: Avoid the combination unless deliberately indicated and monitor toxicity.
CIMA/AEMPS, ficha técnica 62880
- HighMethotrexate
Mechanism: Penicillins may reduce renal elimination and increase toxicity.
Recommendation: Avoid the combination or monitor concentrations, blood count, and renal function.
CIMA/AEMPS, ficha técnica 62880
- ModerateAllopurinol
Mechanism: It increases the likelihood of skin reactions.
Recommendation: Avoid the combination when possible and monitor for rash.
CIMA/AEMPS, ficha técnica 62880
Adverse events
Common (≥1%)
Nausea, diarrhea, and rash
Rare but serious
Anaphylaxis, C. difficile colitis, and severe cytopenias
Pregnancy and lactation
Use during pregnancy only when clearly indicated. Small amounts pass into milk; monitor the infant for diarrhea, candidiasis, or sensitization and assess continuation according to the product.
Recent literature (PubMed)
Novel, effective treatments for Helicobacter pylori infection are needed. This study evaluated the efficacy of vonoprazan, a potassium-competitive acid blocker, vs standard treatment on H pylori eradication in the United States and Europe. In a randomized, controlled, phase 3 trial, treatment-naïve adults with H pylori infection were randomized 1:1:1 to open-label vonoprazan dual therapy (20 mg vonoprazan twice daily; 1 g amoxicillin 3 times daily), or double-blind triple therapy twice a day (vonoprazan 20 mg or lansoprazole 30 mg; amoxicillin 1 g; clarithromycin 500 mg) for 14 days. The primary outcome was noninferiority in eradication rates in patients without clarithromycin- and amoxicillin-resistant strains (noninferiority margin = 10%). Secondary outcomes assessed superiority in eradication rates in clarithromycin-resistant infections, and in all patients. A total of 1046 patients were randomized. Primary outcome eradication rates (nonresistant strains): vonoprazan triple therapy 84.7%, dual therapy 78.5%, vs lansoprazole triple therapy 78.8% (both noninferior; difference 5.9%; 95% confidence interval [CI], -0.8 to 12.6; P < .001; difference -0.3%; 95% CI, -7.4 to 6.8; P = .007, respectively). Eradication rates in clarithromycin-resistant infections: vonoprazan triple therapy 65.8%, dual therapy 69.6%, vs lansoprazole triple therapy 31.9% (both superior; difference 33.9%; 95% CI, 17.7-48.1; P < .001; difference 37.7%; 95% CI, 20.5-52.6; P < .001, respectively). In all patients, vonoprazan triple and dual therapy were superior to lansoprazole triple therapy (80.8% and 77.2%, respectively, vs 68.5%, difference 12.3%; 95% CI, 5.7-18.8; P < .001; difference 8.7%; 95% CI, 1.9-15.4; P = .013). Overall frequency of treatment-emergent adverse events was similar between vonoprazan and lansoprazole regimens (P > .05). Both vonoprazan-based regimens were superior to proton pump inhibitor-based triple therapy in clarithromycin-resistant strains and in the overall study pop
Febrile urinary tract infection (fUTI) in well-appearing children is conventionally treated with a standard 10-day course of oral antibiotic. The objective of this study is to determine the noninferiority (5% threshold) of a 5-day amoxicillin-clavulanate course compared with a 10-day regimen to treat fUTIs. This is a multicenter, investigator-initiated, parallel-group, randomized, controlled trial. We randomly assigned children aged 3 months to 5 years with a noncomplicated fUTI to receive amoxicillin-clavulanate 50 + 7.12 mg/kg/day orally in 3 divided doses for 5 or 10 days. The primary end point was the recurrence of a urinary tract infection within 30 days after the completion of therapy. Secondary end points were the difference in prevalence of clinical recovery, adverse drug-related events, and resistance to amoxicillin-clavulanic acid and/or to other antibiotics when a recurrent infection occurred. From May 2020 through September 2022, 175 children were assessed for eligibility and 142 underwent randomization. The recurrence rate within 30 days of the end of therapy was 2.8% (2/72) in the short group and 14.3% (10/70) in the standard group. The difference between the 2 groups was -11.51% (95% confidence interval, -20.54 to -2.47). The recurrence rate of fUTI within 30 days from the end of therapy was 1.4% (1/72) in the short group and 5.7% (4/70) in the standard group (95% confidence interval, -10.4 to 1.75). This study demonstrates that a 5-day course is noninferior to a 10-day course of oral amoxicillin-clavulanate.
Community-acquired pneumonia (CAP) is a common respiratory infection in children, with viral etiologies predominating. Bacterial pathogens such as Streptococcus pneumoniae and Mycoplasma pneumoniae also contribute significantly. Diagnosis relies primarily on clinical findings, with imaging reserved for severe cases. Treatment depends on the etiology, with amoxicillin as the first-line antibiotic for bacterial CAP and macrolides for atypical pneumonia. Supportive care, including oxygen therapy, is crucial for severe cases. Vaccination has drastically reduced CAP-related mortality, but new epidemiologic trends necessitate continued research. This review provides an updated approach to diagnosing, managing, and preventing pediatric CAP. The combination of amoxicillin and clavulanate is an oral antibiotic widely used in the treatment of mild-to-moderate bacterial infections including sinusitis, bronchitis, otitis media, cellulitis and community acquired pneumonia. Amoxicillin-clavulanate is currently the most common cause of clinically apparent, drug induced acute liver injury both in the United States and Europe.
Acute rhinosinusitis causes more than 30 million patients to seek health care per year in the United States. Respiratory tract infections, including bronchitis and sinusitis, account for 75% of outpatient antibiotic prescriptions in primary care. Sinusitis is a clinical diagnosis; the challenge lies in distinguishing between the symptoms of bacterial and viral sinusitis. Cardinal features of acute bacterial rhinosinusitis are unilateral facial pain or pressure, fever greater than 102°F (39°C), and purulent nasal discharge with obstruction of the nasal passages. Antibiotics should be considered for patients with 3 or more days of severe symptoms, significant worsening after 3 to 5 days of symptoms, or 7 or more days of symptoms. Diagnostic testing for acute rhinosinusitis with antral puncture is impractical because of its invasiveness. Point-of-care testing for elevated C-reactive protein may be helpful, but it is not widely available. Studies have shown that amoxicillin is as effective as amoxicillin-clavulanate as a first-line treatment for acute bacterial rhinosinusitis for those without a beta-lactam allergy. For patients with a beta-lactam allergy, appropriate antibiotics include doxycycline or a respiratory fluoroquinolone; clindamycin plus a third-generation cephalosporin is an option for children with non-type I hypersensitivity to beta-lactam antibiotics. Supportive care for rhinosinusitis, including use of saline irrigation, nasal steroids or antihistamines, and decongestants, may help reduce the severity of symptoms. Most episodes of rhinosinusitis are self-limited, lasting 7 to 10 days. Complications of rhinosinusitis are rare but may include orbital cellulitis, meningitis, and abscess. Computed tomography and referral to an otolaryngologist should be considered for patients with recurrent rhinosinusitis or concern about complications.