- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Research data suggests that the pharmacokinetics of dobutamine in children do not differ much from those in adults. There are however greater inter-individual differences, particularly in the neonatal period because of the immaturity of the myocardium (contractility) and/or the number of receptors that are present.
The following mean pharmacokinetuic parameters ± SEM are reported in 13 premature and terme neonates (27-42 weken postmenstrual age) (Martinez et al 1992):
| Css (dosis 2,5 µg/kg/min) | 21 ± 3 ng/ml |
| Css (dosis 5 µg/kg/min) | 49 ± 4 ng/ml |
| Css (dosis 7,5 µg/kg/min) | 68 ± 4 ng/ml |
| Cl | 90 ± 38 ml/min/kg |
(Hallik et al. 2020) reported the following pharmacokinetic parametersderived from a population pharmacokinetic model, for a typical premature neonate of 1,618 kg and 1 day postnatal age.
| t½ (min) | 5.34 |
| Cl (ml/min/kg) | 424.4 |
| Vd (l/kg) | 3.27 |
The following mean ± SE pharmacokinetic parameters are reported in children of 1 month of age tot 18 years of age. z(Berg et al. 1993, Berg et al. 1993, Habib et al. 1992, Schwartz et al1991):
| Css at 2.5 µg/kg/min (n=12) | 46 ng/ml |
| Css at 5.0 µg/kg/min (n=27) | 105 ± 19 (3.79 - 400) ng/ml |
| Css at 10 µg/kg/min (n=12) | >160 ng/ml |
| t½ (n=10) | 1.65 ± 0.2 min |
| Cl (n=35) | 82-115 (38 - 218) ml/min/kg |
| Vd (n=10) | 1.13 ± 0.70 (0.09 - 5.64) l/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
| Circulatory insufficiency |
|---|
|
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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
Increase in systolic blood pressure, systemic hypertension or hypotension, tachycardia, headache, increase in pulmonary capillary wedge pressure (especially at age <1 year) leading to pulmonary congestion, edema and symptomatic complaints.
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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
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
Additional caution is needed in children in particular at age ≤ 1 because of possible differences in haemodynamic effects (quantitative and qualitative) in comparison with adults.
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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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| Adrenergic and dopaminergic agents | ||
|---|---|---|
| C01CA24 | ||
| C01CA04 | ||
| C01CA26 | ||
| C01CA02 | ||
| C01CA17 | ||
| C01CA24 | ||
| C01CA03 | ||
| C01CA06 | ||
| Phosphodiesterase inhibitors | ||
|---|---|---|
| C01CE02 | ||
| Other cardiac stimulants | ||
|---|---|---|
| C01CX08 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Centrapharm BV, SPC Dobutamine (RVG 19143) 03-12-2019, www.geneesmiddeleninformatiebank.nl
- Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 28 maart 2018
- Berg, R. A., et al, Dobutamine pharmacokinetics and pharmacodynamics in normal children and adolescents., J Pharmacol Exp Ther, 1993, 265(3), 1232-8
- Habib, D. M., et al., Dobutamine pharmacokinetics and pharmacodynamics in pediatric intensive care patients., Crit Care Med, 1992, 20(5), 601-8
- Hallik, M., et al., Population pharmacokinetics and pharmacodynamics of dobutamine in neonates on the first days of life., Br J Clin Pharmacol, 2020, 86(2), 318-28
- Greenough, A. et al, Randomized trial comparing dopamine and dobutamine in preterm infant., Eur J Pediatr, 1993, 152(11), 925-7
- Berg, R. A., et al, Dobutamine infusions in stable, critically ill children: pharmacokinetics and hemodynamic actions., Crit Care Med, 1993, 21(5), 678-86
- Klarr, J. M., et al, Randomized, blind trial of dopamine versus dobutamine for treatment of hypotension in preterm infants with respiratory distress syndrome, J Pediatr, 1994, 125(1), 117-22
- Bravo, M. C., et al, Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants, J Pediatr, 2015, 167(3), 572
- Martinez, A. M., et al, Dobutamine pharmacokinetics and cardiovascular responses in critically ill neonates., Pediatrics, 1992, 89(1), 47-51
- Hentschel, R., et al., Impact on blood pressure and intestinal perfusion of dobutamine or dopamine in hypotensive preterm infants, Biol Neonate, 1995, 68(5), 318-24
- Osborn, D., et al., Randomized trial of dobutamine versus dopamine in preterm infants with low systemic blood flow., J Pediatr, 2002, 140(2), 183-91
- Robel-Tillig, E., et al, Cardiovascular impact of dobutamine in neonates with myocardial dysfunction., Early Hum Dev, 2007, 83(5), 307-12
- Roze, J. C., et al, Response to dobutamine and dopamine in the hypotensive very preterm infant., Arch Dis Child, 1993, 69(1 Spec No), 59-63
- Stopfkuchen, H., et al, Effects of dobutamine on left ventricular performance in newborns as determined by systolic time intervals, Eur J Pediatr, 1987, 146(2), 135-9
- Ruelas-Orozco, G., et al., Assessment of therapy for arterial hypotension in critically ill preterm infants., Am J Perinatol, 2000, 17(2), 95-9
- Schwartz, P. H., et al, The pharmacokinetics of dobutamine in pediatric intensive care unit patients., Drug Metab Dispos, 1991, 19(3), 14-9
- Subhedar, N. V., et al, Dopamine versus dobutamine for hypotensive preterm infants, Cochrane Database Syst Rev, 2003, (3), Cd00124
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Changes
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