Erythromycin

Generic name
Erythromycin
Brand name
ATC Code
J01FA01
Compare …

Erythromycin

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following kinetic data was found for erythromycin ethyl succinate in children aged less than 4 months [Patamasucon]:

  1 dose 10 mg/kg Steady state 40 mg/kg
Cmax (µg/ml) 1.1 ± 0.5 1.3 ± 0.2
Tmax (hours) 1.8 ± 0.48 0.8 ± 0.11
t½ (hours) 2.26 ± 0.41 2.42 ± 0.31

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.

General Dose Info

CAUTION: different dosing frequencies depending on the salt form of the product

  • The dosage forms containing erythromycin as ethyl succinate or as stearate are administered in 3-4 times daily.
  • The dosage forms containing erythromycin as an estolate are administered in 2 times daily.

(Patamasucon 1981; SmPC  Infectomycin saft; SmPC Erythrocine ES; SmPC Erythromycin-ratiopharm)

Dosages

Go to:

Bacterial infections
  • Oral
    • < 1 week
      • Erytromycin (base) 30 mg/kg/day in divided doses.
      • Directions for administration:

        The formulations that contain erythromycin as the ethyl succinate should be taken during or immediately after a meal.

    • 4 years up to 8 years
      • Erytromycin (base) 30 - 50 mg/kg/day in divided doses. Max: 1.500 mg/day.
      • Directions for administration:

        The formulations that contain erythromycin as the ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

    • 8 years up to 12 years
      • Erytromycin (base) 30 - 50 mg/kg/day in divided doses. Max: 2.000 mg/day.

      • The formulations that contain erythromycin as the ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

    • 12 years up to 15 years
      • Erytromycin (base) 30 - 50 mg/kg/day in divided doses. Max: 3.000 mg/day.
      • Directions for administration:

        The formulations that contain erythromycin as the ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

    • ≥ 15 years
      • Erytromycin (base) 30 - 50 mg/kg/day in divided doses. Max: 4.000 mg/day.
      • Directions for administration:

        The formulations that contain erythromycin as the ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

  • Intravenous
    • < 1 week and weight at birth < 2000 g
      • Erytromycin (base) 20 mg/kg/day in 2 doses.

      • Intravenous administration should be slow (30-60 minutes); arrhythmia has been observed when given too quickly.

    • < 1 week and weight at birth ≥ 2000 g
      • Erytromycin (base) 30 - 45 mg/kg/day in 3 doses.

      • Intravenous administration should be slow (30-60 minutes); arrhythmia has been observed when given too quickly.

    • 1 week up to 4 weeks
      [9] [19]
      • Erytromycin (base) 30 - 45 mg/kg/day in 3 doses.

      • Intravenous administration should be slow (30-60 minutes); arrhythmia has been observed when given too quickly.

    • 1 month up to 2 years
      • Erytromycin (base) 30 - 50 mg/kg/day in 2 - 4 doses. Max: 500 mg/day. The dose may be doubled in serious infections..

      • Intravenous administration should be slow (60 minutes); arrhythmia has been observed when given too quickly.

    • 2 years up to 8 years
      • Erytromycin (base) 30 - 50 mg/kg/day in 2 - 4 doses. Max: 1.000 mg/day.

      • Intravenous administration should be slow (60 minutes); arrhythmia has been observed when given too quickly.

    • 8 years up to 18 years
      • Erytromycin (base) 25 - 50 mg/kg/day in 3 - 4 doses. Max: 4.000 mg/day. Alternatively: as a continuous infusion.

      • Intermittent intravenous administration should be slow (60 minutes); arrhythmia has been observed when given too quickly or administer as a continuous infusion.

    • 1 week up to 4 weeks
      • Erytromycin (base) 30 - 45 mg/kg/day in 3 doses.

      • Intravenous administration should be slow (30-60 minutes); arrhythmia has been observed when given too quickly.

    • 1 week up to 4 weeks
      • Erytromycin (base) 30 - 45 mg/kg/day in 3 doses.

      • Intravenous administration should be slow (30-60 minutes); arrhythmia has been observed when given too quickly.
Impaired stomach emptying (prokinetic agent)
  • Oral
    • Premature infants Gestational age 32 weeks up to 37 weeks
      • Erythromycin (base): 12 mg/kg/day in 4 doses.
      • Directions for administration:

        The formulations that contain erythromycin as the ethyl succinate should be taken during or immediately after a meal.
Chlamydia trachomatis (including neonatal conjunctivitis)
  • Oral
    • Term neonate
      • Erytromycin (base) 50 mg/kg/day in divided doses.
      • Duration of treatment:

        10-14 days

      • Directions for administration:

        The formulations that contain erythromycin as ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

    • 1 month up to 18 years
      • Erytromycin (base) 50 mg/kg/day in divided doses.
      • Duration of treatment:

        10-14 days

      • Directions for administration:

        The formulations that contain erythromycin as ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

    • 1 month up to 18 years
      [13] [17] [18]
      • Erytromycin (base) 50 mg/kg/day in divided doses.
      • Duration of treatment:

        10-14 days

      • Directions for administration:

        The formulations that contain erythromycin as ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.

    • Term neonate
      [13] [17] [18]
      • Erytromycin (base) 50 mg/kg/day in divided doses.
      • Duration of treatment:

        10-14 days

      • Directions for administration:

        The formulations that contain erythromycin as ethyl succinate should be taken during or immediately after a meal; the erythromycin stearate one hour beforehand.
CAUTION:
  • Oral
    • 0 years up to 18 years

      • Dosing frequencies is dependient on the salt form of the product

        • The dosage forms containing erythromycin as ethyl succinate or as stearate are administered in 3-4 times daily.
        • The dosage forms containing erythromycin as an estolate are administered in 2 times daily.

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.

Based on the kinetics, it does not seem likely that dose adjustment is required [Hartwig, Informatorium Medicamentorum, SmPC].

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

Gastrointestinal disorders, hypertrophic pyloric stenosis, arrhythmias, impaired hepatic function

 Severe cutaneous hypersensitivity reactions (erythema multiforme, Steven-Johnson-syndrome, toxic epidermal necrolysis) ocurr especially in children of all ages [SmPC].
 

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

Erythromycin can be painful in infusions.

Prescribing erythromycin as a prokinetic agent should be carefully thought through, as the drug is known to have a lot of side effects and interactions and can lead to resistance. The drug should be prescribed for this application selectively and with great caution.

Macrolid use by children during the first 2 weeks after birth is associated with a severely elevated risk of pyloric stenosis (relative risk – RR – of 29.8). Use of macrolides by children aged between 14 and 120 days triples the risk (RR = 3.24). For that reason, erythromycin should be prescribed with caution for children aged up to 4 months.

Erythromycin ES should be taken during or immediately after a meal, as it is in fact absorbed well with food.
Dose should be adjusted in children with impaired liver function. There are indications that oral administration in neonates increases the risk of hypertrophic pyloric stenosis; consider this diagnosis in the event of vomiting or irritation with food. Prolonged or repeated use of erythromycin can result in excessive growth of non-susceptible bacteria or fungi. Intravenous administration should be slow (30-60 minutes); arrhythmia has been observed when given too quickly.
 

Interactions

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

MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS

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

Macrolides
J01FA10
J01FA09
J01FA06
Lincosamides
J01FF01

References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
  2. Chicella MF, et al, Prokinetic drug therapy in children: a review of current options, Ann Pharmacother, 2005, 39, 706-11
  3. Curry JI, et al, Review article: erythromycin as a prokinetic agent in infants and children, Aliment Pharmacol Ther, 2001, 15, 595-603
  4. Honein MA, et al, Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study, Lancet, 1999, 354, 2101-5
  5. Mahon BE, et al, Maternal and infant use of erythromycin and other macrolide antibiotics as risk factors for infantile hypertrophic pyloric stenosis., J Pediatr, 2001, 139, 380-4
  6. Ng PC, Use of oral erythromycin for the treatment of gastrointestinal dysmotility in preterm infants, Neonatology, 2009, 95(2), 97-104
  7. Patole S, et al, Erythromycin as a prokinetic agent in preterm neonates: a systematic review, Arch Dis Child Fetal Neonatal Ed, 2005, 90, 301-6
  8. Waites KB, et al, Serum concentrations of erythromycin after intravenous infusion in preterm neonates treated for Ureaplasma urealyticum infection, Pediatr Infect Dis J., 1994, 13, 287-93
  9. Amdipharm Limited, SPC Erythrocine ES (RVG 10248) 21-02-2023, www.geneesmiddeleninformatiebank.nl
  10. Furth van AM et al, Werkboek Infectieziekten bij Kinderen, VU Uitgeverij, 2008, 2e druk
  11. Lam HS, et al, Use of prokinetics in the preterm infant, Curr Opin Pediatr, 2011, Apr;23(2), 156-60
  12. Razzaq A, et al, Erythromycin establishes early oral feeding in neonates operated for congenital intestinal atresias, Pediatr Surg Int, 2009, Apr;25(4), 361-4
  13. HJC de Vries et al., Multidisciplinaire richtlijn SOA, Nederlandse Vereniging voor Dermatologie en Venereologie (NVDV), 25-02-2019, 61
  14. Lund M., Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. , BMJ, 2014, 348, g1908
  15. Patamasucon P et al., Pharmacokinetics of erythromycin ethylsuccinate and estolate in infants under 4 months of age., Antimicrob Agents Chemother., 1981, May;19(5), 736-9
  16. ratiopharm, SmPC Erythromycin-ratiopharm® 500 mg Filmtabletten (12952.00.00), April 2018
  17. Zikic, A., et al., Treatment of Neonatal Chlamydial Conjunctivitis: A Systematic Review and Meta-analysis., J Pediatric Infect Dis Soc, 2018, 7(3), e107-e115
  18. Van Egmond-Ebbeling et al., NVK Werkboek Kinderinfectieziekten, https://werkboeken.nvk.nl/kinderinfectieziekten/Orgaansysteem/Oog#neonataleconjunctivitis
  19. Amdipharm Limited, SmPC Erytromycine IV (RVG 01800) 11-08-2023, www.geneesmiddeleninformatiebank.nl
  20. InfectoPharm Artzneimittel und Concilium GmHB, SmPC Infectomycin saft (3002131-01-03), www.fachinfo.de, 02-2023
  21. Lund M., Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study., BMJ, 2014, 348, g1908

Changes

Therapeutic Drug Monitoring


Overdose