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amoxicillin clavulanate recommended

Amoxicillin-clavulanate: Recommended by current major guidelines for a wide range of bacterial infections

Pack-shot

Choose the confidence of guideline-recommended antibiotic, to lead the fight against antimicrobial resistance and prevent recurrence of common bacterial infections.

Pack-shot

Choose the confidence of guideline-recommended antibiotic, to lead the fight against antimicrobial resistance and prevent recurrence of common bacterial infections.

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Macrolides
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Augmentin safety information19

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. Marchisio P, et al. Pediatr Infect Dis J. 2019;38(12S Suppl):S10–21.
  2. Lieberthal A, et al. Pediatrics. 2013;131:e964–99.
  3. Suzuki HG, et al. BMJ Open 2020;10:e035343.
  4. World Health Organization. 22nd WHO Essential Medicines List, 2021. Available from: https://www.who.int/ publications/i/item/WHO-MHP-HPS-EML-2021.02. Accessed September 2023.
  5. Rosenfeld RM, et al. Head Neck Surg. 2015;152(Suppl 2):S1–39.
  6. Chow AW, et al. Clin Infect Dis 2012;54(8):e72–112.
  7. Orlandi RR, et al. Int Forum Allergy Rhinol. 2021;11(3):213–739.
  8. FDA Drug Safety Communication. FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. Available  from: https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm. Accessed September 2023.
  9. Shulman ST, et al. Clin Infect Dis. 2012;55(10):e86–102.
  10. Munck H, et al. Eur J Clin Microbiol Infect Dis. 2018;37(7):1221–30.
  11. Metlay JP, et al. Am J Respir Crit Care Med. 2019;200(7):e45-67.
  12. Pneumonia (community acquired): antimicrobial prescribing. NICE guideline. 16 September 2019. Available from: https://www.nice.org.uk/guidance/ng138/resources/pneumonia-communityacquiredantimicrobialprescribingp df-66141726069445. Accessed September 2023.
  13. Bradley, et al. Clin Infect Dis. 2011;53(7):e25-76.
  14. Harris M, et al. Thorax. 2011;66 Suppl 2:ii1–23.
  15. Lim WS, et al. Thorax.2009;64 Suppl 3:iii1-55.
  16. Stevens DL, et al. Clin Infect Dis 2014;1-43. 
  17. Lipsky BA, et al. Clin Infect Dis 2012;54(12):132–73.
  18. Cellulitis and erysipelas: antimicrobial prescribing. NICE guideline. 27 September 2019. Available from: https://www.nice.org.uk/guidance/ng141/resources/cellulitis-and-erysipelas-antimicrobialprescribingp df-66141774778309. Accessed September2023.
  19. Augmentin prescribing information.

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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