메토클로프라미드염산염수화물

Metoclopramide Hydrochloride Hydrate

원료 코드 M223013 국내 제품 4개 (단일제 4 · 복합제 0) DUR 성분 D000425

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

⚠️ DUR 안전사용 기준

  • 🤰 임부금기 2등급 (용액주사제/당의정/필름코팅정)
  • 🧒 연령금기 1세 미만 추체외로장애 위험성 증가(정제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제/용액주사제)
  • 🧒 연령금기 1세 미만 추체외로장애 위험성 증가(정제)
  • ⚖️ 용량주의 하루 최대 메토클로프라미드염산염 30밀리그램 (정제)
  • ⚖️ 용량주의 하루 최대 메토클로프라미드염산염 30밀리그램 메토클로프라미드염산염 30mg(정제)
  • 📅 투여기간주의 최대 5일 (정제)
  • 📅 투여기간주의 최대 5일 (정제)
복합제·제형별 기준 2개 더 보기
  • 🧒 연령금기 1세 미만 추체외로장애 위험성 증가(정제)
  • ⚖️ 용량주의 하루 최대 메토클로프라미드염산염수화물 30밀리그램 (용액주사제)

이 성분만 든 제품 (단일제 4)

광고

병용금기 성분 (2)

아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).

상대 성분이유
돔페리돈QTc 연장 효과 증대로 심각한 위험(Torsade de Pointes, 심각한 심실성 부정맥 포함) 가능성
레보도파레보도파의 효과 감소

🌐 해외(미국) 정보 — 메토클로프라미드염산염수화물

미국 FDA·NLM 자료 · 2026-10-03 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)

The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of post-prandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of 12-week trial using doses of 15 mg 4 times daily. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting …

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine. Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. Metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks. Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions. Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following …

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 76,711건 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 TARDIVE DYSKINESIA16,218
  2. 2 EXTRAPYRAMIDAL DISORDER12,921
  3. 3 NERVOUS SYSTEM DISORDER7,526
  4. 4 DYSTONIA7,115
  5. 5 오심nausea6,492
  6. 6 통증pain5,970
  7. 7 구토vomiting4,944
  8. 8 불안anxiety4,097
  9. 9 설사diarrhoea4,094
  10. 10 ECONOMIC PROBLEM3,961
  11. 11 INCORRECT DRUG ADMINISTRATION DURATION3,710
  12. 12 피로fatigue3,531

미국 리콜 기록

FDA 리콜(회수) 기록 6건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2025.07.02 · 2등급 · Teva Pharmaceuticals USA, Inc Presence of foreign tablets/capsules.
  • 2021.08.25 · 2등급 · Teva Pharmaceuticals USA Lack of Assurance of Sterility
  • 2021.05.26 · 2등급 · Teva Pharmaceuticals USA Lack of Assurance of Sterility
  • 2021.03.10 · 2등급 · Teva Pharmaceuticals USA Chemical contamination; Unknown brown residue adhering to the inside of one vial.
  • 2021.03.03 · 2등급 · Teva Pharmaceuticals USA Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

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.

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