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

Interactions
PK
Renal impairment
References

Phenoxymethylpenicillin

Generic name
Phenoxymethylpenicillin
Brand name
ATC Code
J01CE02

Pharmacokinetics in children

The following kinetic parameters have been found after oral administration (40 mg/kg/day in 4 doses) in children [Fujita 1983]:

Cmax Tmax t½
1.018 mcg/ml 35 min 0.74 hours

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

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Available formulations

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Dosages

Moderately severe infections
  • Oral
    • ≥ 1 month and < 30 kg
      • 50 mg/kg/day in 3 - 4 doses.
    • ≥ 30 kg
      • 1.500 mg/day in 3 - 4 doses.
    • ≥ 1 month and < 30 kg
      [2] [3] [5] [21]
      • 50 mg/kg/day in 3 - 4 doses.
    • ≥ 30 kg
      [2] [3] [5] [21]
      • 1.500 mg/day in 3 - 4 doses.
Secondary prophylaxis for group A streptococcal infection (acute rheumatism, Sydenham's chorea), prophylaxis for sickle cell anaemia and (functional) asplenia
  • Oral
    • < 1 year
      • 25.000 IU/kg/day in 2 doses.
    • 1 year up to 5 years
      • 400.000 IU/day in 2 doses.
    • 5 years up to 18 years
      • 800.000 IU/day in 2 doses.
      • Duration of treatment:

        In case of (functional) asplenia, treatment should continue until the age of 6 years (and up to 2 years after splenectomy)

    • < 1 year
      [6] [21]
      • 25.000 IU/kg/day in 2 doses.
    • 1 year up to 5 years
      [6] [7] [8] [9] [21]
      • 400.000 IU/day in 2 doses.
    • 5 years up to 18 years
      [6] [7] [8] [9] [21]
      • 800.000 IU/day in 2 doses.
      • Duration of treatment:

        In case of (functional) asplenia, treatment should continue until the age of 6 years (and up to 2 years after splenectomy)
Prophylaxis for Streptococcus viridans infection in the treatment of AML with high doses of cytarabine
  • Oral
    • 1 month up to 18 years
      • 80.000 IU/kg/day in 3 doses. Max: 6 IEx106/day.
    • 1 month up to 18 years
      [10] [11]
      • 80.000 IU/kg/day in 3 doses. Max: 6 IEx106/day.
Bacterial infections
  • Oral
    • 1 month up to 12 years
      • 25 - 50 mg/kg/day in 3 - 4 doses. Max: 1.500 mg/day.
    • ≥ 12 years
      • 750 - 1.500 mg/day in 3 - 4 doses. Max: 2.000 mg/day.
    • 1 month up to 12 years
      [1] [3] [5] [21]
      • 25 - 50 mg/kg/day in 3 - 4 doses. Max: 1.500 mg/day.
    • ≥ 12 years
      [1] [3] [5] [20] [21]
      • 750 - 1.500 mg/day in 3 - 4 doses. Max: 2.000 mg/day.
    • Term neonate
      • 25 mg/kg/day in 3 doses.
    • Term neonate
      [20]
      • 25 mg/kg/day in 3 doses.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Side effects

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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

Food possibly slows the resorption of phenoxymethylpenicillin and concentrations in the blood are lower as a result; should preferably be taken 1 hour before or 2 hours after a meal. If this causes compliance issues, phenoxymethylpenicillin can be taken with food.

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Interactions

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

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Penicillins with extended spectrum
J01CA04
J01CA01
J01CA11
J01CA08
Beta-lactamase sensitive penicillins
J01CE08
J01CE01
J01CE05
J01CE10
Beta-lactamase resistant penicillins
J01CF01
J01CF05
J01CF02
J01CF02
Combinations of penicillins, incl. beta-lactamase inhibitors
J01CR02
J01CR01, J01CR04
J01CR05
J01CR04

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References

  1. Hexal, SmPC PenHexal 1,0 / 1,5 Mega Einheiten Filmtabletten (41147.00.00), 03/2016
  2. MMI, Online GL. Gelbe Liste Online, Accessed July 13, 2018
  3. Sanofi-Aventis, SmPc Isocillin® 1,2 Mega Filmtabletten (6132032.01.00), 02/2018
  4. Chephasaar, SmPC Ispenoral®1,0/1,5 Mega Filmtabletten (6153784.00.00 / 6153784.01.00), 04/2016
  5. Infectopharm, SmPC INFECTOCILLIN® Trockensaft (6149647.01.01), 03/2016
  6. EMA, EPAR Phenoxymethylpenicilline orale formuleringen NO/W/0002/pdWS/001 08-12-2011, www.hma.eu
  7. Heijboer H et al., Preventie bij en begeleiding van kinderen met sikkelcelziekte en hun ouders. Deel I. Tweede herziene leidraad., www.nvk.nl, Mei 2014.
  8. SKION., Werkboek Supportive care. H2., www.skion.nl, December 2017
  9. Gerber MA et al., Potential mechanisms for failure to eradicate group A streptococci from the pharynx., Pediatrics., 1999, Oct;104(4 Pt 1):, 911-7
  10. Dagnelie CF et al., NHG-Standaard Acute keelpijn (Derde herziening)., Huisarts Wet, 2015, 58(8), 422-9
  11. Centrafarm B.V. , SmPC fenoxymethylpenicilline (RVG 50288) 23-6-2014. , www.geneesmiddeleninformatiebank.nl
  12. Chaudhary S et al. , Penicillin V and rifampin for the treatment of group A streptococcal pharyngitis: a randomized trial of 10 days penicillin vs 10 days penicillin with rifampin during the final 4 days of therapy. , J Pediatr. , 1985 , Mar;106(3), 481-6
  13. Dagnelie CF et al. , NHG-Standaard Acute keelpijn (Derde herziening). , Huisarts Wet , 2015, 58(8), 422-9
  14. Fujita K et al., Comparative pharmacological evaluation of oral benzathine penicillin G and phenoxymethyl penicillin potassium in children., Pediatr Pharmacol (New York)., 1983, 3(1):, 37-41.
  15. Gerber MA et al. , Potential mechanisms for failure to eradicate group A streptococci from the pharynx. , Pediatrics. , 1999 , Oct;104(4 Pt 1):, 911-7
  16. Heijboer H et al. , Preventie bij en begeleiding van kinderen met sikkelcelziekte en hun ouders. Deel I. Tweede herziene leidraad. , www.nvk.nl, Mei 2014.
  17. LCI., Richtlijn voor preventie van infecties bij mensen met (functionele) hypo- en asplenie., 2018
  18. Gaston MH et al., Prophylaxis with oral penicillin in children with sickle cell anemia. A randomized trial., N Engl J Med, 1986, Jun 19;314(25), 1593-9
  19. Hirst C et al., Prophylactic antibiotics for preventing pneumococcal infection in children with sickle cell disease., Cochrane Database Syst Rev., 2014, Nov 6;(11), CD003427
  20. Choeyprasert W., Bacteremia during neutropenic episodes in children undergoing hematopoietic stem cell transplantation with ciprofloxacin and penicillin prophylaxis., Int J Hematol., 2017, Feb;105(2), 213-220
  21. SKION. , Werkboek Supportive care. H2. , www.skion.nl, December 2017
  22. 1A Pharma, SmPC Pen 0,4 Mega TS 400.000 I.E./5 ml Granulat zur Herstellung einer Lösung zum Einnehmen (57982.00.00, 05/2018
  23. Sanofi, SmPC Isocillin Saft 300.000 I.E. /5 ml Pulver zur Herstellung einer Lösung zum Einnehmen (14014.00.00), 02/2018
  24. Ratiopharm, SmPC Penicillin V-ratiopharm® TS (6061728.00.00), 10/2017
  25. AbZ, SmPC Penicillin V 1 Mega Filmtabletten (6030538.00.00), 12/2015
  26. Chaudhary S et al., Penicillin V and rifampin for the treatment of group A streptococcal pharyngitis: a randomized trial of 10 days penicillin vs 10 days penicillin with rifampin during the final 4 days of therapy., J Pediatr., 1985, Mar;106(3), 481-6
  27. AbZ, SmPC Penicillin V 1 Mega Filmtabletten (6030538.00.00), 12/2015
  28. Infectopharm, SmPC INFECTOCILLIN® Trockensaft (6149647.01.01), 03/2016
  29. Centrafarm B.V., SmPC fenoxymethylpenicilline (RVG 50288) 23-6-2014., www.geneesmiddeleninformatiebank.nl

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Changes

Changes