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 BRAND NAMES
- International: Augmentin
 MECHANISM OF ACTION
Amoxicillin binds to penicillin-binding protein (PBP) located inside the bacterial cell well. Penicillins acylate the penicillin-sensitive transpeptidase C-terminal domain by opening the lactam ring. This inactivation of the enzyme prevents the formation of a cross-link of two linear peptidoglycan strands, inhibiting the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins.
Clavulanic acid, produced by the fermentation of Streptomyces Clavuligerus, is a beta-lactam structurally related to the penicillins. By blocking their active sites, clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. The addition of clavulanic acid extends the antimicrobial spectrum of amoxycillin to include organisms normally resistant to amoxycillin due to beta lactamase production.
Treatment of the following infections when caused by susceptible organisms organisms:
- Skin and Skin Structure Infections, including cases caused by β-lactamase producing S. aureus, E. coli and Klebsiella spp. (only some strains may be sensitive).
- Urinary Tract Infections, including cases caused by β-lactamase producing E. coli, P. mirabilis & Klebsiella spp.
- Upper Respiratory Tract Infections, such as sinusitis, including cases caused by β-lactamase producing H.influenzae and M.catarrhalis, and otitis media, especially cases caused by β-lactamase producing H. influenzae, M. catarrhalis and S. aureus.
- Lower Respiratory Tract Infections, especially cases caused by β-lactamase producing H.influenzae and M.catarrhalis.
- Adults and Pediatric Patients > 40 kg: based on amoxycillin component, 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours. (2.1, 2.2)
- Pediatric patients aged 12 weeks (3 months) and older: based on amoxycillin component, 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose.
- Neonates and infants < 12 weeks of age: based on amoxycillin component, 30 mg/kg/day divided every 12 hours. Use of the 125 mg/5 mL oral suspension is recommended.
- Patients with a history of allergic reactions to any penicillin.
- Patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin/Clavulanic acid combination.
 WARNINGS AND PRECAUTIONS
- Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin/Clavulanic acid if a reaction occurs.
- Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment.
- Clostridium difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs.
- Patients with mononucleosis who receive Amoxicillin/Clavulanic acid develop skin rash. Avoid Amoxicillin/Clavulanic acid use in these patients.
- Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.
- Co‑administration with probenecid is not recommended.
- Concomitant use of Amoxicillin/Clavulanic acid and oral anticoagulants may increase the prolongation of prothrombin time.
- Coadministration with allopurinol increases the risk of rash.
- Amoxicillin/Clavulanic acid may reduce efficacy of oral contraceptives
 PREGNANCY AND LACTATION
- Pregnancy Category B (US). Amoxicillin/Clavulanic acid should be used during pregnancy only if clearly needed.
- Nursing Mothers: Amoxicillin has been shown to be excreted in human milk. Amoxicillin/Clavulanic acid use by nursing mothers may lead to sensitization of infants. Caution should be exercised when Amoxicillin/Clavulanic acid is administered to a nursing woman.
 SIDE EFFECTS
Amoxicillin/Clavulanic acid is generally well tolerated. The most frequently reported adverse effects were diarrhea/loose stools, nausea, skin rashes and urticaria, vomiting and vaginitis. The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache