BENZYLPENICILLIN

Crystapen, Pencillin Sodium Biochemie

Reviewed by Clinical Practice Committee and Dr Lesley Voss, Natasha Pool and Elizabeth Oliphant
March 2018
Administration Newborn Drug Protocol Index Newborn Services Home Page

Dose and Administration

  1. 60mg/kg/dose for congenital syphillis.
  2. 90mg/kg/dose for severe sepsis and meningitis. Max daily dose 300mg/kg/day.

Add an aminoglycoside if tolerance is suspected/confirmed.

Postmenstrual Age
(weeks)
Postnatal Age
(days)
Dosing Interval
(hr)
≤29 0 to 28 12
>28 8
30 to 36 0 to 14 12
>14 8
37 to 44 0 to 7 12
>7 8
≥45 All 6

Indications

  1. Directed treatment of neonatal infections caused by susceptible organisms - streptococci (non enterococcal), gonococci.
  2. Treatment of meningitis due to susceptible bacterium including GBS (Group B Streptococcus).
  3. Treatment of congenital syphillis

Contraindications and Precautions

  1. Caution in preterm infants, especially extreme immaturity.
  2. Caution in infants with liver, renal or gastrointestinal disease.
  3. Consider sodium load in renal failure – a dose of 300mg/kg/day provides 0.90 mmol/kg/day of sodium.

Clinical Pharmacology

Benzylpenicillin has bacteriostatic/bacteriocidal actions (depending on its concentration) against most gram positive bacteria and gram negative cocci. Also active against some spirochaetes and actinomycetes. Antimicrobial action is through inhibition of cell wall synthesis.

Well absorbed following intramuscular injection. Widely distributed at varying concentrations in body tissues and fluids. Very little passes into the CSF unless the meninges are inflamed. Larger doses are recommended in meningitis.2 Moderate binding (45-65%) to human plasma protein. Rapidly excreted via the kidney, mainly unchanged. Half life 5-6 hours in healthy newly born preterm infants and 2 hours in full term babies > 1-2 weeks old.

Possible Adverse Effects

  1. Venous irritation, soft tissue injury at site of IV injection.
  2. Pain, soft tissue injury at site of IM injection.
  3. Gastrointestinal disturbance (nausea, vomiting, diarrhoea).
  4. Non specific rashes and skin eruptions.
  5. Fever, pruritis, urticaria.
  6. Seizures with high doses (greater than 400 mg/kg/day) and rapid infusions

Special Considerations

  1. May give concurrently with aminoglycoside therapy for synergistic effect. Administer separately as intravenous administration may cause inactivation.
  2. Adjust dose in suspected renal dysfunction (by lengthening the dosing interval).
  3. Sodium content 1.7 mmol/g.

Evidence

  1. Two RCTs comparing penicillin versus ampicillin in the empiric therapy of extremely low-birth weight neonates at risk of early onset sepsis showed similar effectiveness in change of antibiotics at 72 hours and/or 7 day all-cause mortality. 3, 4
     

References

1 Azimi P.H., Janner D., Berne P. et al. Concentrations of procaine and aqueous penicillin in the cerebrospinal fluid of infants treated for congenital syphilis. J Pediatr 1994;124:649-53.
2 American Academy of Pediatrics. Kimberlin D. W, Brady M.T., Jackson M.A., Long S.S. Eds. 2015 Red Book: Report of the Committee on Infectious Diseases. 30th Ed. Elk Grove Village, IL.
3 Metsvaht T, Ilmoja ML, Parm U, Maipuu L, Merila M, Lutsar I. Comparison of ampicillin plus gentamicin vs penicillin plus gentamicin in empiric treatment of neonates at risk of early onset sepsis. Acta Paediatr 2010;99:665-72.
4 Metsvaht T, Ilmoja ML, Parm U et al. Ampicillin versus penicillin in the empiric therapy of extremely low-birthweight neonates at risk of early onset sepsis. Pediatr Int. 2011 Dec;53(6):873-80.