Expert perspectives on the clinical use of high-dose amoxicillin with clavulanic acid in pediatric practice in Indian settings


  • Manjula S. Department of Medical Services, Micro Labs Limited, Bangalore, Karnataka, India
  • Krishna Kumar M. Department of Medical Services, Micro Labs Limited, Bangalore, Karnataka, India



Amoxicillin, Clavulanic acid, Bacterial infections, Pediatrics


Background: This study was conducted to gather expert opinion regarding the clinical use of a high dose of amoxicillin 600 mg + clavulanic acid 42.9 mg in pediatric practice in Indian settings.

Methods: This cross-sectional study comprised 19 questions and gathered perspectives from pediatricians across India regarding the prescription practices of amoxicillin (600 mg) and clavulanic acid (42.9 mg) for various bacterial infections in pediatric patients. Data were analyzed using descriptive statistics.

Results: Majority (85.65%) of clinicians opined that the high dose of amoxicillin (600 mg) and clavulanic acid (42.9 mg) was very effective in treating bacterial infections in pediatric patients. About 54% of the respondents reported prescribing 600 mg amoxicillin + 42.9 mg clavulanic acid as the high dose for pediatric patients, while 41% of them prescribed 400 mg amoxicillin + 57 mg clavulanic acid as the high dose for pediatric patients. According to 51% of clinicians, the benefits of prescribing the higher-strength formulation of amoxicillin (600 mg) + clavulanic acid (42.9 mg) compared to the standard-strength formulation of amoxicillin (500 mg) + clavulanic acid (125 mg) include increased effectiveness against resistant bacteria, reduced risk of adverse effects, and reduced frequency of dosing.

Conclusions: This study highlighted the clinicians' preference for the high dose of amoxicillin (600 mg) and clavulanic acid (42.9 mg) as an effective treatment for bacterial infections in pediatric patients.  The respondents preferred the high dose over other doses of amoxicillin and clavulanic acid due to the lower percentage of adverse effects.


Bhattarai S, Sharma BK, Subedi N, Ranabhat S, Baral MP. Burden of Serious Bacterial Infections and Multidrug-Resistant Organisms in an Adult Population of Nepal: A Comparative Analysis of Minimally Invasive Tissue Sampling Informed Mortality Surveillance of Community and Hospital Deaths. Clin Infect Dis. 2021;73(5):S415-21.

Million Death Study Collaborators, Bassani DG, Kumar R, Awasthi S, Morris SK, Paul VK, et al. Causes of neonatal and child mortality in India: a nationally representative mortality survey. Lancet. 2010;376(9755):1853-60.

GBD 2017 Child and Adolescent Health Collaborators, Reiner RC, Olsen HE, Ikeda CT, Echko MM, Ballestreros KE, et al. Diseases, Injuries, and Risk Factors in Child and Adolescent Health, 1990 to 2017: Findings From the Global Burden of Diseases, Injuries, and Risk Factors 2017 Study. JAMA Pediatr. 2019;173(6):e190337.

Ikuta KS, Swetschinski LR, Aguilar GR, Sharara F, Mestrovic T, Gray AP, et al. Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet. 2022;400(10369):2221-48.

Pathak A, Upadhayay R, Mathur A, Rathi S, Lundborg CS. Incidence, clinical profile, and risk factors for serious bacterial infections in children hospitalized with fever in Ujjain, India. BMC Infect Dis. 2020;20:162.

Gjini E, Paupério FFS, Ganusov VV. Treatment timing shifts the benefits of short and long antibiotic treatment over infection. Evol Med Public Health. 2020;2020(1):249-63.

Fusco NM, Nichols K. Common bacterial infections and their treatment in hospitalized pediatric patients. Am J Health-System Pharmacy. 2019;76(19):1521-31.

Geddes AM, Klugman KP, Rolinson GN. Introduction: historical perspective and development of amoxicillin/clavulanate. Int J Antimicrob Agents. 2007;30(2):S109-112.

Evans J, Hanoodi M, Wittler M. Amoxicillin Clavulanate. In: StatPearls. Treasure Island (FL): StatPearls Publishing. 2024.

Veeraraghavan B, Bakthavatchalam YD, Sahni RD. Orally Administered Amoxicillin/Clavulanate: Current Role in Outpatient Therapy. Infect Dis Ther. 2021;10(1):15-25.

Klein JO. Amoxicillin/clavulanate for infections in infants and children: past, present and future. Pediatr Infect Dis J. 2003;22(8):S139.

White AR. Augmentin(R) (amoxicillin/clavulanate) in the treatment of community-acquired respiratory tract infection: a review of the continuing development of an innovative antimicrobial agent. J Antimicrobial Chemotherapy. 2004;53(90001):3i-20.

Chu CH, Wang MC, Lin LY, Tu TY, Huang CY, Liao WH, et al. High-Dose Amoxicillin with Clavulanate for the Treatment of Acute Otitis Media in Children. Scientific World J. 2014;2014:1-6.

Dagan R, Hoberman A, Johnson C, Leibovitz E, Arguedas A, Rose F, et al. Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media. Pediatric Infect Dis J. 2001;20:829-37.

Navarro AS. New formulations of amoxicillin/ clavulanic acid: a pharmacokinetic and pharmacodynamic review. Clin Pharmacokinetics. 2005;44(11):1097-116.

Lahiry S, Dalal K, Pawar A, Kotak B. High-Dose amoxicillin supported with clavulanic acid as empirical therapy in acute otitis media. Asian J Med Sci. 2021;12(4):134-144.

Marchant CD, Shurin PA, Johnson CE, Murdell-Panek D, Feinstein JC, Fulton D, et al. A randomized controlled trial of amoxicillin plus clavulanate compared with cefaclor for treatment of acute otitis media. J Pediatr. 1986;109(5):891-6.

Wald ER, Nash D, Eickhoff J. Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. Pediatrics. 2009;124(1):9-15.

Hoberman A, Dagan R, Leibovitz E, Rosenblut A, Johnson CE, Huff A, et al. Large dosage amoxicillin/clavulanate, compared with azithromycin, for the treatment of bacterial acute otitis media in children. Pediatr Infect Dis J. 2005;24(6):525-32.






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