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Amoxicillin-clavulanate: Continues to demonstrate favourable susceptibility against common pathogens of community-acquired infections*

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Augmentin safety information13

Contraindications

AUGMENTIN is contra-indicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins

AUGMENTIN is contra-indicated in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction. 

Warnings and precautions

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity

Adverse Events

Very Common: Diarrhoea (in adults)
Common: nausea, vomiting, mucocutaneous candidiasis, diarrhoea (in children)

References

  1. Pichichero ME. Pediatr Infect Dis J. 2000;19(9):911–6.
  2. Torumkuney D, et al. J Antimicrob Chemother. 2020;75(Suppl 1):i76-i87.
  3. Torumkuney D, et al. J Antimicrob Chemother. 2020;75(Suppl 1):i76-i87.
  4. Doern GV and Brecher SM. J Clin Microbiol. 2011;49(9_Suppl):S11–14.
  5. Survey of Antibiotic Resistance (SOAR) results: respiratory pathogen susceptibility. J Antimicrob Chemother. 2016;71(Suppl1):i3–i19.
  6. Survey of Antibiotic Resistance (SOAR) results 2: respiratory pathogen susceptibility. J Antimicrob Chemother. 2018;73(Suppl 5):v1–42.
  7. Survey of Antibiotic Resistance (SOAR) results 3: respiratory pathogen susceptibility. J Antimicrob Chemother. 2020;75(Suppl 1):i1–i111.
  8. Scaglione F, et al. Antimicrob Agents Chemother. 2003;47(9):2987–9.
  9. Shoar S and Musher DM. Pneumonia (Nathan). 2020;12:11.
  10. Tinelli M, et al. Emerg Infect Dis. 2009;15(2): 250–57.
  11. Xiao N, et al. Infect Drug Resist. 2019;12:2495–503.
  12. Hirose Y, et al. Cell Rep. 2021;34(13):108924.
  13. Augmentin prescribing information.

 

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For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
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 Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Directorate General of Pharmaceutical Affairs & Drug Control
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357686
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: www.moh.gov.om

دائرة التيقظ و المعلومات الدوائية
المديرية العامة للصيدلة و الرقابة الدوائية
وزارة الصحة, سلطنة عمان
0096822357687 / 0096822357686 :هاتف
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد الالكتروني
www.moh.gov.om :الموقع الالكتروني

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PM-RCH-ACA-WCNT-240003 Date of preparation: July 2024