Intravenous Dose: 30mg/kg/dose
(N.B the dose is based on total drug not the amoxicillin component)
 

Postmenstrual Age (weeks)	Postnatal Age (days)	Dosing Interval (hr)
<37	Until term corrected	12
37 to 44	0 to 6	12
	≥ 7 days	8

Oral Dose: Neonate 0.25ml / kg (of amoxicillin 125mg + clavulanic acid 31.25mg per 5 ml syrup) three times a day

Indications

Augmentin® (amoxicillin/clavulanic acid) should be reserved for treatment of infections where amoxicillin alone is ineffective due to inactivation by beta lactamase enzymes. It may be used to rationalise antibiotics when infants are receiving amoxicillin and require additional cover against staphylococci that would normally be provided by adding flucloxacillin.

Contraindications¹

1. Hypersensitivity to penicillins / cephalosporins.

2. Previous history of jaundice / hepatic dysfunction associated with Augmentin (or
   amoxicillin/clavulanic acid combination).

Precautions^1,6

1. Caution in infants with hepatic dysfunction.

2. Reduce dose with renal impairment. When high intravenous doses are being administered, maintain adequate fluid intake to reduce the possibility of amoxicillin crystalluria.

3. Use suspension with caution in patients with phenylketonuria as it contains aspartame, a
   source of phenylalanine.

Clinical Pharmacology^1,3,6

Augmentin ® is a beta-lactam antibacterial penicillin co-formulated with a beta-lactamase
inhibitor (clavulanic acid) which extends the spectrum of the amoxicillin component of the
product. Clavulanic acid itself does not possess antimicrobial activity.

Both components of Augmentin ® (amoxicillin and clavulanic acid) are rapidly absorbed by the oral
route. Absorption is enhanced when taken with food. The pharmacokinetics of amoxicillin and
clavulanic acid are similar, and neither appears to affect the other to any great extent. For
further information on amoxicillin pharmacokinetics refer to the NBS Amoxicillin protocol.
Clavulanic acid is eliminated by both renal and non-renal routes.

Possible Adverse Effects^1,2

1. Oral candida

2. Diarrhoea and vomiting

3. Hepatic events have rarely been reported in children. However there is a greater risk of
   acute liver toxicity with the amoxicillin/clavulanic acid combination than with amoxicillin alone. This may be associated with prolonged treatment and may occur during or after treatment has ceased. The CSM (Committee on Safety in Medicines/Medicines Control Agency, UK) has recommended that co-amoxiclav should normally be administered for a period no greater than 14 days.

4. Rashes, skin eruptions, pruritis.

Special Considerations⁴

1. Not suitable for intramuscular administration ⁴
2. The stability of the injection is concentration dependent: the more concentrated the
   solution the less stable. The clavulanic acid degrades more rapidly than the amoxicillin content.
3. Monitor: renal & hepatic function and FBC if on prolonged therapy.