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약물정보/의약품

레트로졸 과용; Letrozole overdosage

??? : 방금 페마라를 2알 먹었는데요, 문제 없을까요?

페마라 정

letrozole은 10mg (4T)까지 multiple-dose 임상에서 내약성이 좋은 것이 확인되었습니다.

시판 후 letrozole 62.5mg (25T)를 복용한 경우가 보고되었는데, 해당 경우에도 심각한 부작용은 없었던 것으로 보고되었지만, 이러한 상황에 대한 자료는 제한적입니다.

 


Isolated cases of Femara® (letrozole tablets) overdose have been reported. In these instances, the highest single dose ingested was 62.5 mg or 25 tablets. While no serious adverse events were reported in these cases, because of the limited data available, no firm recommendations for treatment can be made. However, emesis could be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs are also appropriate. In singledose studies, the highest dose used was 30 mg, which was well tolerated; in multiple-dose trials, the largest dose of 10 mg was well tolerated. Lethality was observed in mice and rats following single oral doses that were equal to or greater than 2,000 mg/kg (about 4,000 to 8,000 times the daily maximum recommended human dose on a mg/m2 basis); death was associated with reduced motor activity, ataxia and dyspnea. Lethality was observed in cats following single IV doses that were equal to or greater than 10 mg/kg (about 50 times the daily maximum recommended human dose on a mg/m2 basis); death was preceded by depressed blood pressure and arrhythmias.

 

 

< 참고문헌 >

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020726s014lbl.pdf