Pharmacokinetics in children

The following mean (range) pharmacokinetic parameters are reported after continuous infusion of dopamine in premature and term neonatea (24-43 weken GA) (Bhatt-Mehta et al. 1991, Padbury et al. 1990, Zaritsky et al. 1988):

Gestational age and post-natal age or weight do not effect the clearance of dopamine in (preterm) neonates. The great inter-individual variation that is nevertheless seen is as yet not explained.

The renal clearance in children less than 2 years of age (mean 82.3 ± 27.7 ml / kg / min) is almost 2 times that in children over 2 years (mean 45.9 ± 17 mg / kg / min) (Notterman et al. 1990)

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

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Dopamine can cause or exacerbate partial hypopituitarism and euthyroid sick syndrome in critically ill infants and children (Filippi et al. 2007; Van den Berghe et al 1994.)

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

Watch out for ventricular extrasystoles.

• During treatment, monitor blood volume, electrolytes, diastolic blood pressure, cardiac contractility, peripheral perfusion distribution and urine output
• Watch for cardiac side effects and peripheral vascular disease. If necessary, decrease infusion rate or discontinue treatment. Newborn infants are more sensitive to vasoconstrictive effects.
• Administer through a large vein. Subcutaneous, intramuscular or intra-arterial administration should be avoided.
• Gradually taper treatment to avoid hypotension.
• Use of dopamine in children with sepsis in primary care is not recommended due to signals of increased mortality.
• Dopamine has potential adverse effects on the risk of infection, especially with high doses or prolonged use. Carefully weigh the risk of infection against the benefits of treatment for the individual patient.

[SmPC Neoatricon]

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. Bhatt-Mehta V, et al, Dopamine and dobutamine in pediatric therapy, Pharmacotherapy, 1989, 9(5), 303-14
2. Eldadah MK, et al, Pharmacokinetics of dopamine in infants and children, Crit Care Med, 1991, Aug19(8), 1008-11
3. Padbury JF, et al, Pharmacokinetics of dopamine in critically ill newborn infants, J Pediatr, 1990, Sep;117(3), 472-6.
4. Padbury JF, et al, Dopamine pharmacokinetics in critically ill newborn infants, J Pediatr, 1987, Feb;110(2), 293-8
5. Zaritsky A, et al, Steady-state dopamine clearance in critically ill infants and children, Crit Care Med, 1988 , Mar;16(3), 217-20
6. Notterman DA, et al , Dopamine clearance in critically ill infants and children: effect of age and organ system dysfunction, Clin Pharmacol Ther, 1990 , Aug;48(2), 138-47
7. Pellicer A, et al, Early systemic hypotension and vasopressor support in low birth weight infants: impact on neurodevelopment, Pediatrics, 2009, May;123(5), 1369-76
8. Osborn DA, et al, Left ventricular contractility in extremely premature infants in the first day and response to inotropes, Pediatr Res, 2007 , Mar;61(3), 335-40
9. Valverde E, et al, Dopamine versus epinephrine for cardiovascular support in low birth weight infants: analysis of systemic effects and neonatal clinical outcomes, Pediatrics, 2006 , Jun;117(6), e1213-22
10. Cuevas L, et al, The effect of low-dose dopamine infusion on cardiopulmonary and renal status in premature newborns with respiratory distress syndrome, Am J Dis Child, 1991 , Jul;145(7), 799-803
11. Pellicer A, et al, Cardiovascular support for low birth weight infants and cerebral hemodynamics: a randomized, blinded, clinical trial, Pediatrics, 2005, Jun;115(6), 1501-12
12. Subhedar NV, et al, Dopamine versus dobutamine for hypotensive preterm infants., Cochrane Database Syst Rev, 2003, (3), CD001242
13. Seri I. , Cardiovascular, renal, and endocrine actions of dopamine in neonates and children., J Pediatr., 1995, Mar;126(3), 333-44
14. Kleinman ME, et al, Pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Pediatrics, 2010 , Nov;126(5), e1361-99
15. Seri I, et al, Effects of low-dose dopamine infusion on cardiovascular and renal functions, cerebral blood flow, and plasma catecholamine levels in sick preterm neonates, Pediatr Res, 1993 , Dec;34(6), 742-9
16. Rice BA, et al, The case against renal dose dopamine in the pediatric intensive care unit., AACN Clin Issues, 2005, Apr-Jun;16(2), 246-51
17. Lynch SK, et al, The effect of dopamine on glomerular filtration rate in normotensive, oliguric premature neonates, Pediatr Nephrol, 2003, Jul;18(7), 649-52
18. Prins I, et al, Low-dose dopamine in neonatal and pediatric intensive care: a systematic review., Intensive Care Med, 2001 , Jan;27(1), 206-10
19. Van den Berghe G, et al, Dopamine suppresses pituitary function in infants and children, Crit Care Med, 1994, 22, 1747-53
20. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 28 maart 2018
21. Bouissou, A., et al, Hypotension in preterm infants with significant patent ductus arteriosus: effects of dopamine., J Pediatr, 2008, 153(6), 790-4
22. 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
23. DiSessa, T. G., et al. , The cardiovascular effects of dopamine in the severely asphyxiated neonate, J Pediatr, 1981, 99(5), 772-6
24. Bourchier, D., et al, Randomised trial of dopamine compared with hydrocortisone for the treatment of hypotensive very low birthweight infants, Arch Dis Child Fetal Neonatal, 1997, Ed 76 (3), F174-8
25. Filippi, L., et al, Dopamine versus dobutamine in very low birthweight infants: endocrine effects., Arch Dis Child Fetal Neonatal, 2007, Ed 92(5), F367-71
26. Greenough, A., et al., Randomized trial comparing dopamine and dobutamine in preterm infants., Eur J Pediatr, 1993, 152(11), 925-7
27. 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
28. Ruelas-Orozco, G., et al., Assessment of therapy for arterial hypotension in critically ill preterm infants, Am J Perinato, 2000, 17(2), 95-9
29. Sassano-Higgins, S., et al, A meta-analysis of dopamine use in hypotensive preterm infants: blood pressure and cerebral hemodynamics., J Perinatol, 2011, 31(10), 647-55
30. BrePco Biopharma Ltd, SmPC Neoatricon (EU/1/24/1804) 19-06-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring

Overdose