Benzathine benzylpenicillin

Generic name
Benzathine benzylpenicillin
Brand name
ATC Code
J01CE08
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Benzathine benzylpenicillin

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Infection with group A haemolytic streptococci (GABHS), pneumonia based on S. pneumoniae
Prophylaxis for GABHS infection
Syphilis without neurological involvement (congenital; primary and secondary stage; early or late latent stage; syphilis of unknown duration)
  • Intramuscular
    • 0 years up to 18 years
      [2] [9] [13]
      • 50.000 IU/kg/dose once (in congenital, primary or secondary stage or in early latent stage) or once a week for 3 weeks (in late latent or latent for unknown duration). Max: 2.400.000 IU/dose.
        • IV treatment with benzylpenicilline is preferable.
        • Treatment in consultation with an infectiologist.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
Adjustment not necessary
GFR 10-30 ml/min/1.73 m2
generalized recommendations cannot be given. An assessment must be made per patient of the desired effect against the risks of side effects on overdosing and failure of the therapy on underdosing.
GFR < 10 ml/min/1.73 m2
generalized recommendations cannot be given. An assessment must be made per patient of the desired effect against the risks of side effects on overdosing and failure of the therapy on underdosing.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

After i.m. administration, muscle necrosis and inflammation at the site of administration may occur.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Administrations are intramuscular and not intravenous.

Only inject slowly and deep into the muscle, preferably into the gluteus; in children aged under 2 years, preferably mid-laterally in the thigh.

To obtain good syringeability of the preparation, it is recommended to use a needle with an internal diameter of at least 0.9 mm [SmPC]. A smaller needle size reduces pain upon injection, but is not always feasible in practice due to poor syringeability of the preparation.

The pain of injection can also be reduced by  increasing the volume of penicillin from 2.5 to 3.5 ml with the usual solvent (water for injection) and waiting until the alcohol used for disinfecting the skin has evaporated. A large volume (4 ml) also gives problems. In the study by Amir (1998), benzathine benzylpenicillin was administered in a 1% lidocaine solution in order to reduce the pain. 

 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

BETA-LACTAM ANTIBACTERIALS, PENICILLINS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Penicillins with extended spectrum
J01CA04
J01CA01
Beta-lactamase sensitive penicillins
J01CE01
J01CE02
Beta-lactamase resistant penicillins
J01CF02
Combinations of penicillins, incl. beta-lactamase inhibitors
J01CR02
J01CR05

References

  1. Aksit S, et al, Seasonal benzathine penicillin G prophylaxis for recurrent streptococcal pharyngitis in children, Acta Paediatr Jpn, 1998, Jun;40(3), 256-8
  2. Sandoz B.V, SmPC Benzathinebenzylpenicilline (RVG 118693-5) 09-06-202, www.geneesmiddeleninformatiebank.nl
  3. Franssen MJAM et al, Werkboek Kinderreumatologie, VU Uitgeverij, 2008, 2e druk
  4. Lue HC, et al, Long-term outcome of patients with rheumatic fever receiving benzathine penicillin G prophylaxis every three weeks versus every four weeks, J Pediatr, 1994, Nov;125(5 Pt 1), 812-6
  5. Ginsburg CM, et al, Serum penicillin concentrations after intramuscular administration of benzathine penicillin G in children, Pediatrics, 1982, Apr;69(4), 452-4
  6. Kassem AS, et al, Rheumatic fever prophylaxis using benzathine penicillin G (BPG): two- week versus four-week regimens: comparison of two brands of BPG, Pediatrics, 1996, Jun;97(6 Pt 2, 992-5
  7. Lagos R, et al, Benzathine penicillin G and miocamycin in the treatment of children with streptococcal pharyngitis: a controlled therapeutic trial] Penicilina G benzatina y miocamicina en el tratamiento de ninos con faringitis estreptococica: ensayo terapeutico cont, Rev Med Chil, 1993, Nov;121(11), 1274-9
  8. Camargos PA, et al, Benzathine penicillin for unilateral lobar or segmental infiltrates presumptively caused by Streptococcus pneumoniae in children 2-12 years old, J Trop Pediatr, 1997, Dec;43(6), 353-60
  9. Paryani SG, et al, Treatment of asymptomatic congenital syphilis: benzathine versus procaine penicillin G therapy., J Pediatr, 1994, Sep;125(3), 471-5.
  10. Riedner G, et al, Single-dose azithromycin versus penicillin G benzathine for the treatment of early syphilis, N Engl J Med, 2005, Sep 22;353(12), 1236-44
  11. Amir J, et al, Lidocaine as a diluent for administration of benzathine penicillin G, Pediatr Infect Dis J, 1998, Oct;17(10), 890-3
  12. HJC de Vries et al, Richtlijn SOA voor de tweede lijn, Nederlandse Vereniging voor Dermatologie en Venereologie (NVDV). , www.huidarts.info, 2012, 102
  13. RIVM- Landelijke Coördinatie Infectieziektebestrijding, Richtlijn Syfilis, www.lci.nl, Jan-2020
  14. Informatorium Medicamentorum, (Interacties), Geraadpleegd 09 okt 2014
  15. Informatorium Medicamentorum, (Interacties), Geraadpleegd 09 okt 2014

Changes

Therapeutic Drug Monitoring


Overdose