Confusion Acetaminophen Dosing Changes Based on NO Evidence in Adults

Confusion Acetaminophen Dosing Changes Based on NO Evidence in Adults
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DOI:
10.2165/11633010-000000000-00000
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发表时间:
2012-06-01
期刊:
影响因子:
3
通讯作者:
Royal, Mike A.
Royal, Mike A.
中科院分区:
医学4区
文献类型:
--
作者:
Krenzelok, Edward P.;Royal, Mike A.

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对乙酰氨基酚(扑热息痛)在美国的医疗保健中起着至关重要的作用,每年作为非处方药使用的剂量超过250亿剂。每年有超过2亿张含有对乙酰氨基酚的处方,通常与阿片类药物结合使用。虽然对乙酰氨基酚被认为是一种安全有效的镇痛剂和解热剂,但如果不适当地摄入超过治疗量的剂量,也会导致显著的发病率和死亡率(肝毒性)。1977年和1988年分别通过美国食品药品监督管理局(FDA)非处方药专论程序,在单独行动中确定了3900-4000 mg的最大每日治疗剂量。FDA已经召开了多次咨询委员会会议来评估对乙酰氨基酚及其安全性,并建议(但不是强制性的)将最大日剂量从3900- 4000 mg减少到3000-3250 mg。2011年,Tylenol(R)品牌对乙酰氨基酚的生产商McNeil自愿将其500 mg片剂产品的最大日剂量降至3000 mg/天,并承诺将其325 mg/片产品的标签改为3250 mg/天。仿制药生产商未改变其给药方案,并与已确定的各论剂量保持一致。因此,当消费者和医疗保健专业人员试图确定对乙酰氨基酚的适当治疗剂量时,混淆将是不可避免的。对乙酰氨基酚的正确剂量是:如果使用500 mg片剂,则为3000 mg;如果使用325 mg片剂,则为3250 mg;如果使用650 mg关节炎强度产品,则为3900 mg?
Acetaminophen (paracetamol) plays a vital role in American health care, with in excess of 25 billion doses being used annually as a nonprescription medication. Over 200 million acetaminophen-containing prescriptions, usually in combination with an opioid, are dispensed annually. While acetaminophen is recognized as a safe and effective analgesic and antipyretic, it is also associated with significant morbidity and mortality (hepatotoxicity) if doses in excess of the therapeutic amount are ingested inappropriately. The maximum daily therapeutic dose of 3900-4000 mg was established in separate actions in 1977 and 1988, respectively, via the Food and Drug Administration (FDA) monograph process for nonprescription medications. The FDA has conducted multiple advisory committee meetings to evaluate acetaminophen and its safety profile, and has suggested (but not mandated) a reduction in the maximum daily dosage from 3900-4000mg to 3000-3250 mg. In 2011, McNeil, the producer of the Tylenol (R) brand of acetaminophen, voluntarily reduced the maximum daily dose of its 500mg tablet product to 3000mg/day, and it has pledged to change the labeling of its 325mg/tablet product to reflect a maximum of 3250 mg/day. Generic manufacturers have not changed their dosing regimens and they have remained consistent with the established monograph dose. Therefore, confusion will be inevitable as both consumers and health care professionals try to determine the proper therapeutic dose of acetaminophen. Which is the correct dose of acetaminophen: 3000mg if 500mg tablets are used, 3250mg with 325mg tablets, or 3900mg when 650mg arthritis-strength products are used?