ST LOUIS (MD Consult) - On September 9, 2010, the US Food and Drug Administration (FDA) announced that it has approved Protopam (pralidoxime chloride) for pediatric use. Protopam is indicated for the treatment of poisoning that can occur as a result of exposure to organophosphate pesticides and chemicals. The drug had been previously approved for use in adults, but had been widely used off-label in children.
According to a press release by the FDA, organophosphate pesticides are typically used in farm settings and by professional exterminators. A person poisoned with organophosphate pesticides or chemicals (ie, nerve agents) can experience mild symptoms, such as a rhinorrhea, watery eyes, or vomiting, or more serious symptoms such as difficulty breathing, weakness, and seizures.
Protopam works as an antidote to pesticides and chemicals of the organophosphate class by slowing the attachment of the chemical to nerve endings. The drug can be administered intravenously or intramuscularly.
Adverse reactions that have been reported in association with pediatric and adult use of Protopam include blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate, and increased blood pressure.
圣路易斯(MD Consult)——2010年9月9日,美国食品药品管理局(FDA)宣布,当局已批准Protopam(氯解磷定)的适用人群扩大至儿童。Protopam适用于治疗接触有机磷酸酯杀虫剂和有机磷酸酯化学物引发的中毒。此药先前已获准用于成人,但也一直被超适应证广泛用于儿童。
根据FDA发表的一则声明,有机磷酸酯杀虫剂通常用于农业,由专业灭虫人士应用。有机磷酸酯杀虫剂或化学物(即神经性毒剂)中毒者可出现流涕、流泪或呕吐等轻度的症状,或更严重的症状,如呼吸困难、无力和抽搐等。
Protopam作为一类有机磷酸酯类杀虫剂和化学物中毒的解毒药,其作用机制是减缓此化学成分与神经末梢结合。该药可经静脉注射或肌内注射给药。
已有小儿和成人应用Protopam发生不良反应的报告,这些不良反应包括视力模糊、复视、头晕、头痛、嗜睡、恶心、呼吸困难、心率加快和血压升高等。