Phenoxymethylpenicillin

Generic name
Phenoxymethylpenicillin
Brand name
ATC Code
J01CE02
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Phenoxymethylpenicillin

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

Interactions
PK
Renal impairment
References

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

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

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Non-severe infections
Moderately severe infections
Secondary prophylaxis for group A streptococcal infection (acute rheumatism, Sydenham's chorea), prophylaxis for sickle cell anaemia and (functional) asplenia
  • Oral
    • < 1 year
      [6] [21]
      • 15 mg/kg/day in 2 doses.
    • 1 year up to 5 years
      [6] [7] [8] [9] [21]
      • 250 mg/day in 2 doses.
    • 5 years up to 18 years
      [6] [7] [8] [9] [21]
      • 500 mg/day in 2 doses.
      • Duration of treatment:
        • The prophylaxis of sickle cell anaemia can be discontinued after the age of 12 years unless the case history includes pneumococcal sepsis or meningitis. In that event, the prophylaxis should be lifelong.
        • In actual or functional asplenia, treatment should continue up to the age of 6 (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
      [10] [11]
      • 50 mg/kg/day in 3 doses. Max: 1.500 mg/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
      • 50.000 - 100.000 IU/kg/day in 3 - 4 doses. Max: 4.5 IEx106/day.
    • ≥ 12 years
      • 3 - 4.5 IEx106/day in 3 - 4 doses. Max: 6 IEx106/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
      [20]
      • 50.000 IU/kg/day in 3 doses.
    • Term neonate
      [20]
      • 25 mg/kg/day in 3 doses.

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.

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

Side effects

No information is present at this moment.

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.

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
J01CE08
J01CE01
Beta-lactamase resistant penicillins
J01CF02
Combinations of penicillins, incl. beta-lactamase inhibitors
J01CR02
J01CR05

References

  1. Centrafarm B.V. , SmPC fenoxymethylpenicilline (RVG 50288) 23-6-2014. , www.geneesmiddeleninformatiebank.nl
  2. 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
  3. Dagnelie CF et al. , NHG-Standaard Acute keelpijn (Derde herziening). , Huisarts Wet , 2015, 58(8), 422-9
  4. 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.
  5. 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
  6. 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.
  7. LCI. , Richtlijn voor preventie van infecties bij mensen met (functionele) hypo- en asplenie., 2018
  8. 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
  9. 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
  10. 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
  11. SKION. , Werkboek Supportive care. H2. , www.skion.nl, December 2017
  12. 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
  13. Sanofi, SmPC Isocillin Saft 300.000 I.E. /5 ml Pulver zur Herstellung einer Lösung zum Einnehmen (14014.00.00), 02/2018
  14. Ratiopharm, SmPC Penicillin V-ratiopharm® TS (6061728.00.00), 10/2017
  15. AbZ, SmPC Penicillin V 1 Mega Filmtabletten (6030538.00.00), 12/2015
  16. Hexal, SmPC PenHexal 1,0 / 1,5 Mega Einheiten Filmtabletten (41147.00.00), 03/2016
  17. MMI, Online GL. Gelbe Liste Online, Accessed July 13, 2018
  18. Sanofi-Aventis, SmPc Isocillin® 1,2 Mega Filmtabletten (6132032.01.00), 02/2018
  19. Chephasaar, SmPC Ispenoral®1,0/1,5 Mega Filmtabletten (6153784.00.00 / 6153784.01.00), 04/2016
  20. Infectopharm, SmPC INFECTOCILLIN® Trockensaft (6149647.01.01), 03/2016
  21. EMA, EPAR Phenoxymethylpenicilline orale formuleringen NO/W/0002/pdWS/001 08-12-2011, www.hma.eu

Changes

Therapeutic Drug Monitoring


Overdose