염산나록손

Naloxone Hydrochloride

원료 코드 M080761 국내 제품 3개 (단일제 3 · 복합제 0)

🌐 미국 FDA 자료(영문 라벨·부작용 보고·리콜)가 있습니다. 한국어는 AI 번역 참고용이니 원문을 함께 확인하세요. 해외 정보 보기

이 성분만 든 제품 (단일제 3)

광고

🌐 해외(미국) 정보 — 염산나록손

미국 FDA·NLM 자료 · 2026-10-02 기준

이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY ; Adjunctive Use in Septic Shock ).

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients contained in the formulation.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Drug Dependence Naloxone hydrochloride injection should be administered cautiously to persons, including newborns of mothers, who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome. The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include, but are not limited to, the following: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes. Repeat Administration The patient who has satisfactorily responded to naloxone should be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, since the duration of action of some opioids may exceed that of naloxone. Respiratory Depression Due to Other Drugs Naloxone is not effective against respiratory depression due to non-opioid drugs and in the management of acute toxicity caused by levopropoxyphene. Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone. If an incomplete response occurs, respirations should be mechanically …

미국 제품명 NARCAN, RiVive, Narcan Naloxone HCL

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 36,309건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.

  1. 1 약물 의존drug dependence4,721
  2. 2 DRUG WITHDRAWAL SYNDROME3,762
  3. 3 통증pain3,223
  4. 4 적응증 외 사용off label use2,733
  5. 5 오심nausea2,600
  6. 6 과다복용overdose2,527
  7. 7 구토vomiting2,011
  8. 8 불안anxiety1,734
  9. 9 두통headache1,648
  10. 10 EMOTIONAL DISTRESS1,618
  11. 11 약효 없음drug ineffective1,574
  12. 12 DRUG ABUSE1,458

미국 리콜 기록

FDA 리콜(회수) 기록 4건 중 최근 4건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2022.11.09 · 2등급 · SUN PHARMACEUTICAL INDUSTRIES INC Presence of Foreign Substance
  • 2021.07.14 · 2등급 · Alvogen, Inc Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
  • 2021.06.02 · 2등급 · Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
  • 2018.06.13 · 1등급(심각) · HOSPIRA INC, LAKE FOREST Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.