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Efficacy

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Augmentin is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. 12The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics. 12It is indicated for the short-term treatment of infections caused by susceptible bacteria, including:1-5

Augmentin is indicated for the treatment of the following infections in adults and children:

  • Acute bacterial sinusitis (adequately diagnosed) 1-5
  • Acute otitis media 2-5
  • Acute exacerbations of chronic bronchitis (adequately diagnosed) 2-5
  • Community acquired pneumonia 2-5
  • Cystitis 1-5
  • Pyelonephritis 1-5
  • Cellulitis 1-5
  • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis 1-5
  • Bone and joint infections, in particular osteomyelitis 2-5

Clinical evidence in acute bacterial sinusitis

Sinusitis is diagnosed frequently, and adversely affects quality of life. 6The prevalence of acute bacterial sinusitis is estimated to be 0.3% - 2.0% of common colds and influenza in adults and 5%-10% in children. 7Appropriate use of antibiotics is important to reduce excessive use in viral rhinosinusitis and deter the emergence of antibiotic resistance among respiratory pathogens. 8

The Infectious Disease Society of America recommend in their 2012 clinical practice guideline that symptom management of acute bacterial rhinosinusitis (ABRS) should include the use of analgesics and antipyretics. 8Once ABRS is diagnosed, antibiotic treatment should be started immediately in order to:

  • Shorten illness duration
  • Provide earlier symptomatic relief
  • Restore patient quality of life
  • Prevent recurrence or complications

Why Augmentin for acute bacterial sinusitis?

Amoxicillin-clavulanate achieves an amoxicillin concentration in sinus tissue that is high enough to eradicate common susceptible pathogens, such as Streptococcus pneumoniae.9,  10

Augmentin_mic

Amoxicillin-clavulanate achieves clavulanic acid levels in sinus tissue that are greater than those required in vitro, to irreversibly inhibit beta-lactamases produced by Haemophilus influenzae and Moraxella catarrhalis. 911

Amoxicillin-clavulanate has established evidence of clinical and bacterial efficacy.12-14

*Considerable variability exists in susceptibility patterns to amoxicillin-clavulanate. These will vary with time and geography, always refer to local susceptibility data before prescribing.

Clinical evidence in acute otitis media (AOM)

AOM has been found to occur in over 80% of children by the time they reach 5 years of age, and therefore it is recognised as one of the most common childhood diseases. 15

The American Academy of Pediatrics state in their 2013 clinical practice guideline that pain associated with AOM can be substantial and a treatment to reduce pain is recommended. 16After accurate diagnosis, antibiotic therapy is recommended for initial management of severe uncomplicated AOM. 16 Furthermore, antibiotic therapy or additional observation for initial management of non-severe uncomplicated AOM after accurate diagnosis is recommended.

Why Augmentin for AOM?

Amoxicillin-clavulanate has been shown to infiltrate into the middle ear fluid (MEF) of paediatric patients with AOM both quickly and extensively. 17

Amoxicillin-clavulanate achieves MEF concentrations that exceed the MIC90 (the minimum inhibitory concentration required to inhibit the growth of 90% of bacterial isolates) of common causative pathogens in AOM such as S. pneumoniae, H.influenzae and M. catarrhalis.17

Amoxicillin-clavulanate reduced the duration of middle ear effusion (MEE) effectively. 18 It also reduced the risk for persistent MEE, and possible concomitant hearing impairment in children suffering with AOM. 18

Clinical failures may be more likely to occur in children treated with macrolides (such as azithromycin or clarithromycin) for AOM. 19

Augmentin_AOM

* Susceptibility patterns may vary with time and geography, please refer to local susceptibility data before prescribing.

For information on the safety and tolerability of Augmentin, visit the www.medicines.ie

References:

  1. Augmentin 250 mg/125 mg film-coated tablets SPC available on www.medicines.ie last accessed July 2017
  2. Augmentin 500mg/125mg Film-coated Tablets SPC available on www.medicines.ie last accessed July 2017
  3. Augmentin DUO Suspension 400/57mg SPC available on www.medicines.ie last accessed May 2019
  4. Augmentin 875/125mg Film Coated tablets SPC available on www.medicines.ie last accessed July 2017
  5. Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension SPC available on www.medicines.ie last accessed July 2017
  6. Abzug MJ. J Infect 2014; 68(Suppl 1):S33–S37.
  7. Gwaltney JM Jr et al. Clin Infect Dis 2004; 38(2):227–233.
  8. Chow AW et al. Clin Infect Dis 2012; 54(8):e72–e112.
  9. Jehl F et al. Presse Med 2002; 31(34):1596–1603.
  10. Dinis PB et al. Laryngoscope 2000; 110(6):1050–1055.
  11. Neu HC, Fu KP. Antimicrob Agents Chemother 1978; 14(5):650–655.
  12. Riffer E et al. Curr Med Res Opin 2005; 21(1):61–70.
  13. Arrieta JR et al. Am J Otolaryngol Head Neck Med Surg 2007; 28(2):78–82.
  14. Gwaltney JM et al. Antimicrob Agents Chemother 1997; 41(7):1517–1520.
  15. Coco A et al. Pediatrics 2010; 125(2):214–220.
  16. Lieberthal AS et al. Pediatrics 2013; 131(3):e964–e999.
  17. Scaglione F et al. Antimicrob Agents Chemother 2003; 47(9):2987–2989.
  18. Tapiainen T et al. JAMA Pediatr 2014; 168(7):635–641.
  19. Courter JD et al. Ann Pharmacother 2010; 44(3):471–478.
  20. Dagan R et al. Pediatr Infect Dis J 2000; 19(2):95–104.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Augmentin is a registered trademark of the GlaxoSmithKline group of companies