Amoxicillin Clavulanic Acid

Amoxicillin; clavulanic acid

[1.2gm vial $2.90; one tablet 27 cents]

ADMINISTRATION ROUTES:

  • IV, PO, NG

ALTERNATIVE NAMES:

  • Alpha-amoxyclav, augmentin, synermox.

ICU INDICATIONS:

  1. treatment of infections caused by susceptible organisms

PRESENTATION AND ADMINISTRATION:

  • PO / NG:
    Alpha-amoxyclav 625mg (500mg amoxicillin, 125mg clavulanic acid) white tablets, augmentin 500 (500mg amoxicillin, 125mg clavulanic acid) white tablets, synermox (500mg amoxicillin, 125mg clavulanic acid ) white tablets, alpha-amoxyclav 125mg/5ml suspension (125mg amoxicillin, 31.25mg clavulanic acid), alpha-amoxyclav 250mg/5ml (250mg amoxicillin, 62.5mg clavulanic acid), augmentin forte syrup 250 (250mg amoxicillin, 62.5mg clavulanic acid), augmentin forte syrup 125 (125mg amoxicillin, 31.25mg clavulanic acid).
    Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Augmentin. Augmentin can be given without regard to meals. Liquid is available for NG administration.
  • IV:
    600mg and 1.2g vials (powder). Contain 500mg or 1gm amoxicillin and 100mg or 200mg clavulanic acid. Reconstitute by adding 10ml of water for injection to 600mg vial (final volume 10.5ml) or 20ml to 1.2g vial (final volume 20.9 ml) and agitating until dissolved.
    If less than 600mg is required, add 11.5ml of diluent to 600mg dial to give a solution with a concentration of 50mg/ml. Inject slowly over 3-4 minutes or in 100ml of compatible fluid over 30-40 minutes.
    Compatible for 4 hours with normal saline, 3 hours with Hartmanns.
    Note that amoxicillin and clavulanic acid is less stable in solutions that contain glucose so these solutions should be avoided for intermittent infusions.
    Store at room temperature

DOSAGE:

  • IV:
    1.2gm IV q8hrly
  • PO:
    500mg/125mg PO Q8hrly

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY (for IV dosing):

  • Dose in renal impairment [GFR (ml/min)]
    <10: 600mg every 8 hours
    10-20: dose as in normal renal function
    >20-50: dose as in normal renal function
  • Dose in renal replacement therapy:
    CAPD: 600mg every 8 hours
    HD: 600mg every 8 hours
    CVVHDF: dose as in normal renal function

DOSAGE IN PAEDIATRICS:

  • IV:
    Severe infections: 1st week of life 50mg/kg amoxicillin and 12.5mg/kg clavulanic acid 12hrly; otherwise 50mg/kg amoxicillin and 12.5mg/kg clavulanic acid 6hrly.

CLINICAL PHARMACOLOGY:

  • Augmentin is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the lactamase inhibitor, clavulanate potassium. Clavulanic acid is active against the clinically important plasmid mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Amoxicillin is bactericidal against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide.
  • Amoxicillin/ clavulanic acid has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections:
    Gram-Positive Aerobes:
    Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing). Staphylococci which are resistant to methicillin/oxacillin must be considered resistant to amoxicillin/clavulanic acid.
    Gram-Negative Aerobes:
    Enterobacter species. (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with Augmentin in urinary tract infections caused by these organisms.)
    Escherichia
    coli (beta-lactamase and non-beta-lactamase producing).
    Haemophilus influenzae (beta-lactamase and non-beta-lactamase producing).
    Klebsiella species (all known strains are beta-lactamase producing).
    Moraxella
    catarrhalis (beta-lactamase and non-beta-lactamase producing).
  • Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.
  • Note: additional organisms (not outline above) which are adequately treated with amoxicillin alone should be treated with amoxicillin rather than augmentin.

CONTRAINDICATIONS:

  1. History of allergic reaction to any of the penicillins.
  2. Previous history of cholestatic jaundice/hepatic dysfunction associated with augmentin

WARNINGS

  • Anaphylaxis
    Penicillins are a common cause of anaphylactic reactions
  • Pseudomembranous colitis
    Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.

PRECAUTIONS

  • General:
    Prescribing Amoxicillin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.
  • Laboratory Tests:
    No tests in addition to routine ICU tests are required.
  • Drug/Laboratory Test Interactions:
    None noted.

IMPORTANT DRUG INTERACTIONS FOR THE ICU

  • None of significance

ADVERSE REACTIONS

  • Body as a Whole:
    Serum sickness like reactions, Anaphylaxis
  • Digestive System:
    Nausea, vomiting, diarrhea, and haemorrhagic/pseudomembranous colitis. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
  • Nervous System:
    Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely. Skin: Stevens-Johnson Syndrome, exfoliative dermatitus, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported
  • Haematological System:
    Anaemia, including hemolytic anaemia, thrombocytopaenia, thrombocytopaenic purpura, eosinophilia, leukopaenia, and agranulocytosis have been reported during therapy with penicillins.

Critical Care Drug Manual

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