Clopidogrel

Generic name
Clopidogrel
Brand name
ATC Code
B01AC04
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Clopidogrel

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Pharmacokinetic studies in children have not been conducted.

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

Prevention of thrombotic events (including events in Kawasaki disease
  • Oral
    • Term neonate
      • 1 mg/kg/day in 1 dose
        • In case of therapy failure or bleeding: consider dose adjustment based on a platelet function test as well as consulting a pediatric hematologist.
        • CAVE: in general, high interindividual response variability is described in patients treated with clopidogrel. CYP2C19 poor and intermediate metabolizers may have poor response (clopidogrel is a prodrug).
    • 1 month up to 18 years
      • 1 mg/kg/day in 1 dose. Max: 75 mg/day.
        • In case of therapy failure or bleeding: consider dose adjustment based on a platelet function test as well as consulting a pediatric hematologist.
        • CAVE: in general, high interindividual response variability is described in patients treated with clopidogrel. CYP2C19 poor and intermediate metabolizers may have poor response (clopidogrel is a prodrug).

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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.

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

No information available on specific warnings and precautions in children.

Interactions

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

ANTITHROMBOTIC AGENTS

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

Vitamin K antagonists
B01AA07
B01AA04
Heparin group
B01AB04
B01AB09
B01AB05
B01AB01
B01AB06
B01AB10
Platelet aggregation inhibitors excl. heparin
B01AC06
B01AC09
Enzymes
B01AD02
B01AD01
B01AD04
Direct thrombin inhibitors
B01AE07
Direct factor Xa inhibitors
B01AF02
B01AF01

References

  1. Finkelstein Y, et al., Clopidogrel use in children., J Pediatr., 2005, 147(5), 657-61
  2. Johnson PN, et al., Combination thrombolytic and anti-platelet therapies in an infant with incomplete kawasaki disease and coronary aneurysms., J Pediatr Pharmacol Ther., 2008, 13(4), 242-50
  3. Mondelo García C, et al, [What is the optimal dose of clopidogrel in pediatric patients?], An Pediatr (Engl Ed), 2019, 90(4), 219-23
  4. Wessel DL, et al., Clopidogrel in infants with systemic-to-pulmonary-artery shunts., N Engl J Med., 2013, 368(25), 2377-84
  5. Li JS., et al., Dosing of clopidogrel for platelet inhibition in infants and young children: primary results of the Platelet Inhibition in Children On cLOpidogrel (PICOLO) trial., Circulation., 2008, 117(4), 553-9
  6. Rowley AH, et al., Pathogenesis and management of Kawasaki disease. , Expert Rev Anti Infect Ther. , 2010, 8(2), 197-203
  7. Hanke CA, et al., Prophylactic use of clopidogrel in paediatric cardiac patients., Klin Padiatr., 2012, 224(3), 166-9
  8. Maltz LA, et al., Clopidogrel in a pediatric population: prescribing practice and outcomes. from a single center, Pediatr Cardiol., 2009, 30(2), 99-105
  9. Ramly B., Lymph-node-first Kawasaki disease and giant coronary artery aneurysm. , BMJ Case Rep, 2019, 12(2)
  10. Mertens L, et al, Safety and efficacy of clopidogrel in children with heart disease., J Pediatr., 2008, 153(1), 61-4
  11. Soman T, et al., The risks and safety of clopidogrel in pediatric arterial ischemic stroke, Stroke, 2006, 37(4), 1120-2
  12. Rosenthal DN, et al. , Impact of a modified anti-thrombotic guideline on stroke in children supported with a pediatric ventricular assist device., J Heart Lung Transplan, 2017, 36(11), 1250-7
  13. van Stijn D, et al., Myocardial infarction due to thrombotic occlusion despite anticoagulation in Kawasaki disease - a case report, BMC Pediatr., 2022, 22(1), 85
  14. Wang L, et al., Kawasaki Disease Complicated by Late-Onset Fatal Cerebral Infarction: A Case Report and Literature Review., Front Pediatr., 2021, 9, 598867
  15. Rosenthal DN, et al., Impact of a modified anti-thrombotic guideline on stroke in children supported with a pediatric ventricular assist device., J Heart Lung Transplan, 2017, 36(11), 1250-7
  16. Ramly B., Lymph-node-first Kawasaki disease and giant coronary artery aneurysm., BMJ Case Rep, 2019, 12(2)
  17. Rowley AH, et al., Pathogenesis and management of Kawasaki disease., Expert Rev Anti Infect Ther., 2010, 8(2), 197-203

Changes

Therapeutic Drug Monitoring


Overdose