ST LOUIS (MD Consult) - On December 14, 2010, the US Food and Drug Administration (FDA) issued a warning, cautioning the public about the potential for overdose and subsequent death that could occur with accidental ingestion of benzonatate by children younger than 10 years. Benzonatate is sold under the brand-name Tessalon, and is also sold in generic preparations. The medication is a prescription drug approved for relief of cough in patients older than 10 years.

The FDA has received reports of 31 cases of overdose of benzonatate. Seven cases involved accidental ingestions, all in children younger than 10 years. Five of the seven accidental ingestions resulted in death in children aged 2 years and younger. Two pediatric patients (ages 12 months and 4 years) were hospitalized as a result of accidental benzonatate ingestion and survived the event.

Overdose in children younger than 2 years has been reported after accidental ingestion of as few as 1 or 2 capsules. Persons who experience benzonatate overdose may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). Deaths in children have been reported within hours of the accidental ingestion.

Patients who are prescribed benzonatate should be instructed to keep the medication in a child-resistant container and store it out of the reach of children. If a child accidentally ingests benzonatate, medical attention should be sought immediately.

Overdose of benzonatate has also been reported in adults and adolescents. Patients should be advised that, if they miss a dose, to skip that dose and take the next dose at the next scheduled time. They should not take 2 doses of benzonatate at the same time. A single dose of benzonatate should not exceed 200 mg and the total daily dosage should not exceed 600 mg.

The FDA is adding new information about accidental ingestion resulting in overdose and death in children younger than 10 years to the Warnings and Precautions sections of the labels for benzonatate products. The FDA believes that benzonatate may be attractive to children because of the drug's appearance (it is a round-shaped, liquid-filled gelatin capsule).

圣路易斯(MD Consult)——2010年12月14日，美国食品药品管理局(FDA)发布一则警告，提醒公众，10岁以下的儿童误服苯佐那酯可能会导致药物过量和继发死亡。苯佐那酯以商品名“Tessalon”出售，还以非专利药出售。本药是一种获准用于缓解10岁以上儿童咳嗽症状的处方药。

FDA已经收到了31例苯佐那酯过量的报告。7例患者有误服史且年龄都小于10岁，其中5例年龄≤2岁的患儿死亡。有2例儿科患者(年龄分别为12个月和4岁)因误服苯佐那酯而住院治疗，均幸存下来。

已经有2岁以下的儿童误服1粒或2粒胶囊后发生过量的报告。发生苯佐那酯过量的患者会表现为坐立不安、震颤、抽搐、昏迷和心脏骤停。过量的症状和体征可以在误服后迅速发生(15~20 min内)；有儿童在误服后数小时内死亡的报告。

应嘱使用苯佐那酯的患者将该药放在防儿童开启的容器内并将其储存在儿童触及不到的地方。若儿童误服苯佐那酯，则应该立即就诊。

在成人和青少年中也有苯佐那酯过量的报告。若患者错过了1剂，则建议其跳过此次用药并在下一个用药时间再服用。患者不应该在同一时间服用双倍剂量。苯佐那酯的单剂不应超过200 mg，而每日总剂量不应超过600 mg。

FDA在苯佐那酯药品说明书中的警告事项和注意事项部分补充了一条新信息，即10岁以下的儿童误服苯佐那酯可导致过量和死亡。FDA认为，苯佐那酯的外观(是一种圆形充液凝胶胶囊)对儿童具有吸引力。