Frågedatum: 1999-02-22
RELIS database 1999; id.nr. 14835, DRUGLINE
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Can flumazenil be administered to a newborn child and if so what is the dose recommendation?/nA wom



Fråga: Can flumazenil be administered to a newborn child and if so what is the dose recommendation?

A woman has been administered both nitrazepam and diazepam at several occasions before delivery because of severe delivery related anxiety. After delivery the child was hypotonic and apneic but with a normal heart rate. Diazepam poisoning is one of the diagnosis under consideration.

Sammanfattning: Flumazenil has been used in benzodiazepine overdose in newborns, however the experience is limited. We have found only two case reports of flumazenil treatment of diazepam overdose in newborns. The doses used were 10-20 ug/kg as intravenous bolus doses with a maintenance dose of 10- 50 ug/kg/hour for six hours.

Svar: Flumazenil is a selective and competitive antagonist to the benzodiazepine receptor. It is used to treat benzodiazepine intoxication in adults. The documentation of the use of flumazenil as an antidote in newborns or small children for diazepam poisoning in utero is very sparse (1). We have only found two case reports in the literature, both with successful outcomes (2,3). The first child was treated with an intravenous bolus dose of 10 ug/kg flumazenil and with a maintenance dose of flumazenil infusion at 10 ug/kg/hour (2). The infusion was gradually withdrawn after 6 hours (2). The second child was administered a higher dose, 20 ug/kg intravenously as a bolus dose with a maintenance dose of 50 ug/kg/hour also discontinued after six hours (3). There were no adverse reactions reported in either case.

Similar management of flumazenil intoxication in babies and small children is recommended by the poison information centre (4). 1 Maria Björkstedt, Roche AB, personal communication 2 Cone AM, Nadel S, Sweeney B: Flumazenil reverses diazepam-induced neonatal apnoea and hypotonia (letter). Eur J Pediatr 1993; 152: 458-9 3 Richard P, Autret E, Bardol J, Soyez C, Barbier P, Jonville AP, Ramponi N: The use of flumazenil in a neonate. J Toxicol Clin Toxicol 1991; 29: 137-40 4 Christina Didner, personal communication, The poison information centre

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