Pediatric Formulary

Dosages

Side effects in children

Warnings & precautions in children

Contra-indications in children

Interactions

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

Non-severe infections
Oral ≥ 1 month and < 30 kg ^{[1] [3] [5] [21]} 25 mg/kg/day in 3 - 4 doses. ≥ 30 kg ^{[1] [3] [5] [21]} 750 mg/day in 3 - 4 doses.

Moderately severe infections
Oral ≥ 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 ^{[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)

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.

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.

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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

No information is present at this moment.

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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
	Amoxicillin Related Medicines Menu">	J01CA04
	Ampicillin Related Medicines Menu">	J01CA01

Beta-lactamase sensitive penicillins
	Benzathine benzylpenicillin Related Medicines Menu">	J01CE08
	Benzylpenicillin Related Medicines Menu">	J01CE01

Beta-lactamase resistant penicillins
	Kloksacillin Related Medicines Menu">	J01CF02

Combinations of penicillins, incl. beta-lactamase inhibitors
	Amoxicillin + clavulanic acid Related Medicines Menu">	J01CR02
	Piperacillin (as the sodium salt) / tazobactam (as the sodium salt) Related Medicines Menu">	J01CR05

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References

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

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Phenoxymethylpenicillin

Phenoxymethylpenicillin

Pharmacokinetics in children

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

Available formulations

Dosages

Renal impaiment in children > 3 months

Side effects

Contra-indications

Warnings & precautions in children

Interactions

References

Changes

Changes