Azithromycin

Generic name
Azithromycin
Brand name
ATC Code
J01FA10
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Azithromycin

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Bioavailability 30-40%. Terminal half-life in children (6 months - 16 years) is 55 - 65 h [Stevens 1997, Jacobs 2005].

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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Bacterial infections
  • Oral
    • 1 month up to 18 years
      • 10 mg/kg/day in 1 dose. Max: 500 mg/day.
      • Duration of treatment:

        3 days

      • Alternative treatment regimen: 10 mg/kg/day, max. 500 mg/day on day 1 followed by 5 mg/kg/day, max. 250 mg/day on days 2-5.
Streptococcal pharyngitis
  • Oral
    • 1 month up to 18 years
      • 10 - 20 mg/kg/day in 1 dose. Max: 500 mg/day.
      • Duration of treatment:

        3 days
Chlamydia trachomatis
  • Oral
    • Term neonate
      • 20 mg/kg/day in 1 dose
      • Duration of treatment:

        3 days

    • ≥ 1 month and < 45 kg
      • 10 mg/kg/day in 1 dose
      • Duration of treatment:

        5 days

    • ≥ 1 month and ≥ 45 kg
      • 1.000 mg/dose, once only.
Prophylaxis after a tick bite
  • Oral
    • < 8 years
      • 10 mg/kg/dose, once only. Max single dose: 500 mg/dose.

      • > 8 years:    doxycycline

        Prophylactic treatment can be considered when the tick has been attached to skin for more than 24 hours and prophylaxis is started within 72 hours after removal of the tick.
Early localized Lyme disease (erythema migrans or lymphocytoma)
  • Oral
    • 1 month up to 18 years
      • 10 mg/kg/day in 1 dose. Max: 500 mg/day.
    • ≥ 9 years
      [4]
      • 500 mg/day in 1 dose
      • Duration of treatment:

        5 days
Maintenance therapy for infection with P. aeruginosa in cystic fibrosis
  • Oral
    • 25 up to 40 kg
      • 250 mg/dose 3 times a week: Mon-Wed-Fri.
    • ≥ 40 kg
      • 500 mg/dose 3 times a week: Mon-Wed-Fri.
    • < 25 kg
      • 10 mg/kg/dose 3 times a week: Mon-Wed-Fri.

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 in children

Mild gastrointestinal disorders often occur on oral administration.

After using Azithromycin in neonates (within the first 42 days after birth) cases of infantile hypertrophic pylorus stenosis were reported.

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

Adjust dose in children with reduced hepatic function.
The suspension and the tablets can be taken with food if required. After taking the suspension, a bitter aftertaste can be avoided by drinking fruit juice immediately after taking it.

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, azithromycin should be prescribed with caution for children aged up to 4 months. Inform parents and caregivers to contact the doctor in case of persistent vomiting and irritation when feeding.

The efficacy and safety of prophylaxis against Mycobacterium avium intracellular complex (MAC) infections in children have not been determined.
The quantity of data available about use in children aged < 1 year is limited.

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
J01FA09
J01FA01
J01FA06
Lincosamides
J01FF01

References

  1. Hartwig NC, et al, Vademecum Pediatrische Antimicrobiële Therapie, 2005
  2. CBO, Richtlijn Diagnostiek en behandeling Cystic Fibrosis, www.cbo.nl, 2007
  3. Pfizer BV, SmPC Zithromax (RVG 14999) 09-06-2023, www.geneesmiddeleninformatiebank.nl
  4. CBO, Richtlijn Lymeziekte, www.cbo.nl, 2013, 71-85
  5. de Vries, HJC et al, Richtlijn SOA voor de tweede lijn, Nederlandse Vereniging voor Dermatologie en Venereologie (NVDV, www.huidarts.info, 2012, 61
  6. Lund M. , Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. , BMJ, 2014, 348, g1908
  7. Saiman L et al., Azitromycin in patients with cystic fibrosis chronically infected with Pseudomonas Aeruginosa, JAMA, 2003 Oct 1, 290(13), 1749-56
  8. Wichers IM et al, NHG Behandelrichtlijn Tekenbeet en erythema migrans, 2017, April
  9. Thalhammer, F, et al., Azithromycin-related toxic effects of digitoxin, Br J Clin Pharmacol, 1998, 45, 91-2
  10. Jacobs, RF, et al., Pharmacokinetics of intravenously administered azithromycin in pediatric patients, Pediatr Infect Dis J, 2005, 24(1), 34-9
  11. Stevens, RC, et al., Pharmacokinetics of azithromycin after single- and multiple-doses in children, Pharmacother, 1997, 17(5), 874-80
  12. Pfizer, SmPC Zithromax 500mg Pulver zur Herstellung einer Infusionslösung, 37174.00.01, 11/2017
  13. Dr.Eberth AM, SmPC Azithromycin Dr. Eberth 500 mg Pulver zur Herstellung einer Infusionslösung, 85853.00.00, 01/2018
  14. TEVA, SmPC Azi-TEVA 200mg/5ml Pulver zur Herstellung einer Suspension zum Einnehmen, 67895.00.00, 12/2017
  15. Pfizer, SmPC Zithromax Trockensaft 200mg/5ml Pulver zur Herstellung einer Suspension zum Einnehmen, 25156.00.01, 11/2017
  16. Ratiopharm, SmPC Azithromycin- ratiopharm 250mg Filmtabletten,62285.00.00, 12/2017
  17. Ratiopharm, SmPC Azithromycin ratiopharm 500mg Filmtabletten, 62572.00.00, 11/2017
  18. DenkPharma, SmPC Azithromycin Denk 250mg/500mg Filmtabletten,63092.00.00/63093.00.00, 10/2017
  19. Betapharm, SmPC Azithrobeta 250mg/500mg,58681.00.00/58681.01.00, 02/2015
  20. 1A Pharma, SmPC Azithromycin 1A Pharma 250mg/500mg,60506.00.00/60506.01.00, 12/2017
  21. Pfizer, SmPC Zithromax 250mg/500mg, 371 74.00.00/37174.01.00, 11/2017
  22. Pfizer, SmPC UItreon 600mg Filmtabletten,37344.00.00, 11/2017
  23. MMI, Gelbe Liste I Online., Accessed March 23, 2018
  24. upToDate.com, Azithromycin Topic 8868 Version 293.0, Acessed 07/2018
  25. Sandoz, SmPC Azithromycin-Sandoz für Kinder 200mg/5ml Pulver zur Herstellung einer Suspension zum Einnehmen, 67355.00.00, 06/2015
  26. Aliud Pharma, SmPC Azithromycin AL 200mg/5ml, Pulver zur Herstellung einer Suspension zum Einnehmen,70992.00.00, 11/2017
  27. InfectoPharm, SmPC InfectoAzit Augentropfen, 85076.00.00, 10/2014
  28. Théa Pharma, SmPC Azyter Augentropfen, 66100.00.00, 08/2013
  29. Lund M., Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study., BMJ, 2014, 348, g1908
  30. Ratiopharm, SmPC Azithromycin ratiopharm 500mg Filmtabletten, 62572.00.00, 11/2017
  31. InfectoPharm, SmPC InfectoAzit Augentropfen, 85076.00.00, 10/2014

Changes

Therapeutic Drug Monitoring


Overdose