- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Treatment of venous thrombo-embolic events (VTE) and prevention of recurrent venous thrombo-embolic events (VTE) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| CAUTION: |
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Dose adjustment not neededGFR 30-50 ml/min/1.73 m2
Do not useGFR 10-30 ml/min/1.73 m2
Do not useGFR < 10 ml/min/1.73 m2
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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
Common (1-10%): Anemia, thrombocytopenia, rash, urticaria, hematoma, epistaxis, diarrhea, dyspepsia, nausea, gastroesophageal reflux disease, vomiting, increased liver enzymes, alopecia
Uncommon (0.1-1%): decreased hemoglobin, decreased hematocrit, neutropenia, hypersensitivity, pruritus, intracranial haemorrhage, haemoptosis, gastrointestinal haemorrhage, abdominal pain, rectal haemorrhage, gastroesophagitis, dysphagia, increased ALT and / or AST, hyperbilirubinaemia, skin haemorrhage, genitourinary haemorrhage including haematuria, traumatic haemorrhage.
Further reported: agranulocytosis, anaphylactic reaction, angioedema, bronchospasm, other haemorrhages, gastrointestinal ulcer, including
esophageal ulcers, haemarthrosis,abnormal hepatic function (test)
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
- eGFR <50 mL/min/1.73m2 in paediatric patients
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
Start treatment of VTE with oral dabigatran only after treatment with a parenteral anticoagulant for at least 5 days.
For certain very specific pediatric patients, e.g. patients with small bowel disease where absorption may be impaired, the use of an anticoagulant with parenteral route should be considered.
Discontinuation rules before invasive or surgical procedures for paediatric patients:
Renal function (eGFR in ml/min/1,73 m2) > 80: Stop dabigatran 24 hours before elective surgery
Renal function (eGFR in ml/min/1,73 m2) > 50–80: Stop dabigatran 2 days before elective surgery
Renal function (eGFR in ml/min/1,73 m2) < 50: These patients have not been studied
[EPAR Pradaxa]
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Vitamin K antagonists | ||
|---|---|---|
| B01AA07 | ||
| B01AA04 | ||
| Heparin group | ||
|---|---|---|
| B01AB04 | ||
| B01AB09 | ||
| B01AB05 | ||
| B01AB01 | ||
| B01AB06 | ||
| B01AB10 | ||
| Platelet aggregation inhibitors excl. heparin | ||
|---|---|---|
| B01AC06 | ||
| B01AC04 | ||
| B01AC09 | ||
| Enzymes | ||
|---|---|---|
| B01AD02 | ||
| B01AD01 | ||
| B01AD04 | ||
| Direct factor Xa inhibitors | ||
|---|---|---|
| B01AF02 | ||
| B01AF01 | ||
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Reference
- Boehringer Ingelheim International GmbH, SmPC Pradaxa (EU/1/08/442/001-017) Rev 38, 127-07-2022, www.ema.europa.eu
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Changes
Changes
