- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The following pharmacokinetic parameters are available for intravenous administration in premature infants: [Aranda, J. V. et al 1997, Hirt, D. et al 2008, Van Overmeire, B. et al 2001]
|
PNA |
0-3 h (n=21) |
3 days (n=93) |
5 days (n=93) |
|
Cmax (mg/l) |
1 Dosis (10 mg/kg): 180.6 ± 11.1 |
1 Dosis (10 mg/kg): 33.3-43.5 |
3 Dosen (10-5-5 mg/kg): 28.4-42.4 |
|
t½ (h) |
30.5 ± 4.2 |
42.2-43.1 |
19.7-26.8 |
|
Cl (ml/h/kg) |
2.1 ± 0.3 |
9.5 ± 6.8 |
10.8 ± 6.5 |
|
Vd (ml/kg) |
62.1 ± 3.9 |
357 ± 121 |
349 ± 152 |
PNA= Postnatal age
The following pharmacokinetic parameters are available for oral administration in premature infants: [Barzilay, B. et al 2012, Sangtawesin, V. et al 2006, Sharma, P.K. et al 2003]
|
Cmax (10 mg/kg) |
n=55 |
20.1-31.8 mg/l |
|
Tmax |
n=55 |
3-17 h |
|
t½ |
n=20 |
15.7 ± 3.8 h |
|
Vd |
n=22 |
313 ml/kg |
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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
| Closing a ductus arteriosus |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Very common (> 10%): neutropenia, thrombocytopenia, elevated serum creatinine, decreased sodium. Bronchopulmonary dysplasia.
Common (1-10%): intraventricular hemorrhage, periventricular leukomalacia. Pulmonary hemorrhage. Necrotizing enterocolitis, intestinal perforation. Oliguria, fluid retention, hematuria.
Occasionally (0.1-1%): hypoxemia. Gastrointestinal hemorrhage. Acute renal failure.
Further reported: pulmonary hypertension.
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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
- Life-threatening infection;
- Active bleeding, especially intracranial or gastrointestinal hemorrhage;
- Thrombocytopenia (<50 x 10^9/l) or coagulation disorder;
- Severe renal insufficiency;
- Congenital heart disease in which the ductus arteriosus must remain open for satisfactory pulmonary or systemic blood flow (e.g., severe tetralogy of Fallot, severe coarctation of the aorta);
- Known or suspected necrotizing enterocolitis.
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
Do not use prophylactically in any pregnancy. Do not use in infants with markedly elevated bilirubin concentrations. When used in preterm infants after less than 27 weeks of gestation, efficacy was found to be limited (ductus arteriosus closure rate low (33-50%)) at the recommended dose.
Before administering ibuprofen, perform adequate echocardiographic examination to confirm a hemodynamically significant open ductus arteriosus and to exclude pulmonary hypertension and ductal-dependent heart disease.
Because of possible inhibition of platelet aggregation by ibuprofen, observe the newborn for signs of bleeding.
If hypoxemia occurs, closely monitor pulmonary arterial pressure.
If oliguria occurs with subsequent administration, wait until urine output has returned to normal levels.
Ibuprofen can mask signs of infection
Ibuprofen is metabolized primarily by CYP2C8 and CYP2C9. CYP2C polymorphisms do not affect the action of ibuprofen in closing the ductus arteriosus.
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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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| Prostaglandins | ||
|---|---|---|
| C01EA01 | ||
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References
- Barzilay, B. et al, Pharmacokinetics of oral ibuprofen for patent ductus arteriosus closure in preterm infants, Arch Dis Child Fetal Neonatal Ed, 2012, 97 (2), F116-9
- Sharma, P.K. et al, Pharmacokinetics of oral ibuprofen in premature infants, J Clin Pharmacol, 2003, 43(9), 968-73
- Aranda, J. V. et al, Pharmacokinetics and protein binding of intravenous ibuprofen in the premature newborn infant., Acta Paediatr, 1997, 86 (3), 289-93
- Orphan Europe SARL, SPC Pedea (EU/1/04/284/001) Rev 14;18-06-2019, www.ema.europa.eu
- Werkgroep Neonatale Farmacologie NVK sectie Neonatologie,, Expert opinie , 13 nov 2018
- Hirt, D. et al , An optimized ibuprofen dosing scheme for preterm neonates with patent ductus arteriosus, based on a population pharmacokinetic and pharmacodynamic study, Br J Clin Pharmacol, 2008, 65 (5), 629-36
- Van Overmeire, B. et al, Ibuprofen pharmacokinetics in preterm infants with patent ductus arteriosus, Clin Pharmacol Ther, 2001, 70(4), 336-43
- Sangtawesin, V. et al, Oral ibuprofen prophylaxis for symptomatic patent ductus arteriosus of prematurity, J Med Assoc Thai, 2006, 89(3), 314-21
- Ohlsson, A. et al, Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants., Cochrane Database Syst Rev, 2018, Sep 28;9(9), Cd003481
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Changes
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