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amoxicillin clavulanate proven

Amoxicillin-clavulanate: Proven efficacy in community-acquired bacterial infections


 

Pack-shot

Choose the confidence of Augmentin, your reliable partner in tackling common community-acquired bacterial infections.

Pack-shot

Choose the confidence of Augmentin, your reliable partner in tackling common community-acquired bacterial infections.

amoxicillin clavulanate
Augmentin ES
amoxicillin clavulanate
amoxicillin clavulanate

Augmentin safety information12

Contraindications :

  • In patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. (UAE 457 mg)
  • In patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction. (UAE 457 mg)
  • In patients with known hypersensitivity to penicillins and cephalosporins or to any ingredient of Augmentin, as well as in patients who developed jaundice or hepatic dysfunction during previous Augmentin therapy. [457mg for (Oman, Qatar, Bahrain, Kuwait), & 1gm for all 5 GCC Countries]
  • Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients (ES for all 5 GCC Countries & 625 mg for UAE, Oman, Qatar, Bahrain)
  • History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). (ES for all 5 GCC Countries & 625 mg for UAE, Oman, Qatar, Bahrain)
  • History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid. (ES for all 5 GCC Countries & 625 mg for UAE, Oman, Qatar, Bahrain)
  • Infectious mononucleosis, lymphocytic leukemia: Patients suffering from these diseases are particularly predisposed to exanthema formation during amoxicillin therapy. [457mg for (Oman, Qatar, Bahrain, Kuwait)]
  • Infectious mononucleosis, lymphatic leukaemia: when treated with amoxicillin, patients with these conditions are especially predisposed to skin rashes. (1gm for all 5 GCC Countries)

Undesirable Effects:

Mucocutaneous candidiasis, Diarrhoea, Nausea, vomiting

Kindly note that not all formulations are approved in all countries

References

  1. Scaglione F, et al. Antimicrob Agents Chemother. 2003;47(9):2987–9.
  2. Augmentin ES Prescribing Information.
  3. Data on File: Augmentin ES–600 Phase IV Study. REF-196810.
  4. White AR, et al. J Antimicrob Chemother. 2004;53(Suppl 1):i3–20.
  5. Hoberman A, et al. Pediatr Infect Dis J. 2005;24(6):525–32.
  6. Survey of Antibiotic Resistance (SOAR) results: respiratory pathogen susceptibility. J Antimicrob Chemother. 2016;71(Suppl1):i3–i19.
  7. Haczyński J, et al. Med Sci Monit. 2001;7(5):1016–22.
  8. Asensi F, et al. Rev Esp Quimioter 1999;12(3):211214.
  9.  Lin T-Y, et al. Chang Gung Med J. 2007;30(4):321–32.
  10. Postma DF, et al. N Engl J Med. 2015;372(14):1312–23.
  11. Liu S, et al. Front Pharmacol. 2019;10:489.
  12. Augmentin prescribing information.
  13. Data on file;DNG 2016N290462.
  14. Dagan R and Leibovitz E. Lancet Infect Dis. 2002;2(10):593–604.

 

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Augmentin Prescribing Information

augmentintin combine pi qr code

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
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: www.moh.gov.om

 دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
www.moh.gov.om : الموقع االكتروني

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PM-RCH-ACA-WCNT-240003 Date of preparation: Jan 2025