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

Interactions
PK
Renal impairment
References

Clarithromycin

Generic name
Clarithromycin
Brand name
ATC Code
J01FA09

Pharmacokinetics in children

The bioavailability is 50%.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Available formulations

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Dosages

Bacterial infections
  • Oral
    • Normal preparation (immediate release)
      • Term neonate and ≥ 2000 g
        [22]
        • Clarithromycin 15 mg/kg/day in 2 doses. Max: 500 mg/day. In severe infections up to max 1000 mg/day.
      • 1 month up to 18 years
        [3] [22]
        • Clarithromycin 15 mg/kg/day in 2 doses. Max: 500 mg/day. In severe infections up to max 1000 mg/day.
    • Tablet with regulated release
      • 12 years up to 18 years
        [3]
        • Clarithromycin 500 - 1.000 mg/day in 1 dose. Max: 1.000 mg/day.
  • Intravenous
    • 12 years up to 18 years
      [19]
      • Clarithromycin 1.000 mg/day in 2 doses.
      • Duration of treatment:

        Switch to oral therapy after 2 days in mild infections and after 5 days in severe infections.
Infections in cystic fibrosis
  • Oral
    • 1 month up to 18 years
      [1]
      • Clarithromycin 15 mg/kg/day in 2 doses. Max: 1 g/day.
Eradication of H. pylori (triple therapy)
  • Oral
    • 1 month up to 18 years
      [4] [21]
      • (Clarithromycin) 20 - 30 mg/kg/day in 2 doses. Max: 1 g/day.
      • Duration of treatment:

        14 days

      • Triple therapy: clarithromycin combined with:
        - esomeprazol or omeprazole 1,5 -2,5  mg/kg/day orally in 2 doses
        - amoxicillin 50 mg/kg/day orally in 2 doses. In clarithromycin and metronidazole resistency use high dose amoxicilline: 80-90 mg/kg/day

        <insert hyperlinks to drugmonographs>

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
No dose adjustment needed
GFR 30-50 ml/min/1.73 m2
No dose adjustment needed
GFR 10-30 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uur
When using the controlled release tablet the single dose should be halved - if possible- with a dosing interval of 24 hours. Please note that controlled release tablets cannot be halved. Use a different formulation if needed.
GFR < 10 ml/min/1.73 m2
A general recommendation is not provided

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

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, clarithromycin should be prescribed with caution for children aged up to 4 months.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Interactions

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Macrolides
J01FA10
Lincosamides
J01FF01

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

References

  1. Hartwig NC, et al, Geneesmiddelen-Formularium voor Kinderen, 2005
  2. Kneepkens CMF et al, Werkboek Kindergastroenterologie, 2002
  3. Abbot BV, SPC Klacid (RVG 16752), www.cbg-meb.nl, Geraadpleegd 27 mei 2010, http://db.cbg-meb.nl/IB-teksten/h15868.pdf
  4. NVK. . , Richtlijn Helicobacter Pylori-infectie bij kinderen van 0-18 jaar, 2012
  5. Lund M, Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. , BMJ, 2014, 348, g1908.
  6. HEXAL, SmPC Clarithromycin HEXAL® Filmtabletten (60109.00.00/ 60109.01.00), 03/2018
  7. ratiopharm, SmPC Clarithromycin-ratiopharm® 125 mg/5 ml, 250 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen (58899.00.01), 02/2018
  8. Mylan Healthcare, SmPC Klacid Saft®, 125 mg/5 ml, Granulat zur Herstellung einer Suspension zum Einnehmen (19219.00.01), 03/2018
  9. Mylan Healthcare, SmPC Klacid Uno, 500 mg Retardtablette (61478.00.00), 03/2018
  10. 1 A Pharma, SmPC Clarithromycin - 1 A Pharma® 250 mg, 500 mg Filmtabletten (60113.00.00), 03/2018
  11. Mylan Healthcare, SmPC Klacid® Pro, 250 mg Filmtabletten (28401.00.00), 03/2018
  12. Mylan Healthcare, SmPC Klacid® Filmtabletten, 250 mg (19219.00.00), 03/2018
  13. Mylan Healthcare, SmPC Klacid Saft® Forte 250 mg/5 ml, Granulat zur Herstellung einer Suspension zum Einnehmen (40373.00.00), 03/2018
  14. Basics GmbH, SmPC Clarithromycin Basics 125/250 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen (60345.00.00/ 60345.01.00), 01/2014
  15. HEC Pharm GmbH, SmPC Clarithromycin HEC Pharm 500 mg Retardtabletten (90873.00.00), 02/2015
  16. Aristo Pharma GmbH, SmPC Clarilind® 250/ 500 mg Filmtabletten (63033.00.00/ 63034.00.00), 11/2017
  17. STADApharm GmbH, SmPC Clarithromycin STADA® 250/ 500 mg Filmtabletten (59945.00.00/ 59945.01.00), 05/2017
  18. Mylan Healthcare GmbH, SmPC Klacid® 500 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung (93335.00.00), 11/2017
  19. Mylan Healthcare GmbH, SmPC Klacid® 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (46110.00.00), 11/2017
  20. Dr. Friedrich Eberth Arzneimittel GmbH, SmPC Clarithromycin Eberth 500 mg Pulver zur herstellung einer infusionslösung (85349.00.00), 03/2014
  21. Jones N, et al, Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016), JPGN, 2017, 64, 991–1003
  22. Sandoz BV, SmPC Claritromycine suspensie (RVG 30849) 3 juni 2021, www.geneesmiddeleninformatiebank.nl
  23. Mylan Healthcare GmbH, SmPC Klacid® 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (46110.00.00), 04/2022

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Changes

Changes