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):

(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. 

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):

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

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 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.

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.

Interactions

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

• CARDIOVASCULAR SYSTEM
• CARDIAC THERAPY

CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES

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

References

1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
2. Centrapharm BV, SPC Dobutamine (RVG 19143) 03-12-2019, www.geneesmiddeleninformatiebank.nl
3. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 28 maart 2018
4. Berg, R. A., et al, Dobutamine pharmacokinetics and pharmacodynamics in normal children and adolescents., J Pharmacol Exp Ther, 1993, 265(3), 1232-8
5. Habib, D. M., et al., Dobutamine pharmacokinetics and pharmacodynamics in pediatric intensive care patients., Crit Care Med, 1992, 20(5), 601-8
6. 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
7. Greenough, A. et al, Randomized trial comparing dopamine and dobutamine in preterm infant., Eur J Pediatr, 1993, 152(11), 925-7
8. Berg, R. A., et al, Dobutamine infusions in stable, critically ill children: pharmacokinetics and hemodynamic actions., Crit Care Med, 1993, 21(5), 678-86
9. 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
10. 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
11. Martinez, A. M., et al, Dobutamine pharmacokinetics and cardiovascular responses in critically ill neonates., Pediatrics, 1992, 89(1), 47-51
12. 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
13. 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
14. Robel-Tillig, E., et al, Cardiovascular impact of dobutamine in neonates with myocardial dysfunction., Early Hum Dev, 2007, 83(5), 307-12
15. 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
16. 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
17. Ruelas-Orozco, G., et al., Assessment of therapy for arterial hypotension in critically ill preterm infants., Am J Perinatol, 2000, 17(2), 95-9
18. Schwartz, P. H., et al, The pharmacokinetics of dobutamine in pediatric intensive care unit patients., Drug Metab Dispos, 1991, 19(3), 14-9
19. Subhedar, N. V., et al, Dopamine versus dobutamine for hypotensive preterm infants, Cochrane Database Syst Rev, 2003, (3), Cd00124

Changes

Therapeutic Drug Monitoring

Overdose