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Efficacy

Augmentin is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. 12 The 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. 12 It is indicated for the short-term treatment of infections caused by susceptible bacteria, including:* 1–5

  • Upper respiratory tract infections, including ear, nose and throat infections (e.g. tonsillitis, sinusitis and otitis media, 1–5 including recurrent or persistent acute otitis media (AOM) caused by certain bacteria in paediatric patients; Augmentin ES) 5
  • Lower respiratory tract infections (e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia) 1–5
  • Genito-urinary tract infections (e.g. cystitis, urethritis and pyelonephritis) 1–5
  • Skin and soft-tissue infections 1-5
  • Bone and joint infections (e.g. osteomyelitis) 12
  • Dental infections 1-4 (e.g. dentoalveolar abscess, 12 severe dental abscess with spreading cellulitis) 34
  • Other infections (e.g intra-abdominal sepsis, 12 septic abortion and puerperal sepsis) 1

*Susceptibility to Augmentin will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

 

Clinical evidence in acute bacterial sinusitis

Sinusitis is diagnosed frequently, and adversely affects quality of life. 6 The prevalence of acute bacterial sinusitis is estimated to be 2%–10%. 7 Appropriate 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. 8 Once ABRS is diagnosed, antibiotic treatment should start immediately in order to: 8

  • 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.* 910

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. 16 After 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. 16

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

*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 Safety section

Before prescribing please consult the full SPC which you can request from GSK or access on the website of the Pharmaceutical Services of the Ministry of Health http://www.phs.moh.gov.cy/web/guest/drug-search

References:

  1. SmPC Augmentin Tablets 1gr
  2. Smpc Augmentin Tablets 500/125 mg
  3. SmPC Augmentin suspension 457 mg/5 ml
  4. SmPC Augmentin ES 600 mg/42.9 mg/5 ml
  5. Abzug MJ. J Infect 2014; 68(Suppl 1):S33–S37.
  6. Gwaltney JM Jr et al. Clin Infect Dis 2004; 38(2):227–233.
  7. Chow AW et al. Clin Infect Dis 2012; 54(8):e72–e112.
  8. Jehl F et al. Presse Med 2002; 31(34):1596–1603.
  9. Dinis PB et al. Laryngoscope 2000; 110(6):1050–1055.
  10. Neu HC, Fu KP. Antimicrob Agents Chemother 1978; 14(5):650–655.
  11. Riffer E et al. Curr Med Res Opin 2005; 21(1):61–70.
  12. Arrieta JR et al. Am J Otolaryngol Head Neck Med Surg 2007; 28(2):78– 82.
  13. Gwaltney JM et al. Antimicrob Agents Chemother 1997; 41(7):1517–1520.
  14. Coco A et al. Pediatrics 2010; 125(2):214–220.
  15. Lieberthal AS et al. Pediatrics 2013; 131(3):e964–e999.
  16. Scaglione F et al. Antimicrob Agents Chemother 2003; 47(9):2987–2989.
  17. Tapiainen T et al. JAMA Pediatr 2014; 168(7):635–641.
  18. Courter JD et al. Ann Pharmacother 2010; 44(3):471–478.
  19. Dagan R et al. Pediatr Infect Dis J 2000; 19(2):95–104.

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