Pharmacokinetics in children

The bioavailability is 50%.

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

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>

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

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.

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.

Interactions

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

• ANTIINFECTIVES FOR SYSTEMIC USE
• ANTIBACTERIALS FOR SYSTEMIC USE

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
	Azithromycin Related Medicines Menu">	J01FA10

Lincosamides
	Clindamycin Related Medicines Menu">	J01FF01

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

Changes

Therapeutic Drug Monitoring

Overdose