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Oxytocin

원료 코드 M040453 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D000667

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이 성분만 든 제품 (단일제 1)

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미국 FDA·NLM 자료 · 2026-10-05 기준

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

Oxytocic [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor. Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion; In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery; In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; In fetal distress where delivery is not imminent; Where adequate uterine activity fails to achieve satisfactory progress; Where the uterus is already hyperactive or hypertonic; In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord; In patients with hypersensitivity to the drug.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Pitocin, when given for induction of labor or augmentation of uterine activity, should be administered only by the intravenous route and with adequate medical supervision in a hospital.

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with oxytocin. There are no known indications for use in the first trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated. Nonteratogenic Effects See ADVERSE REACTIONS in the fetus or neonate.

미국 제품명 Pitocin, GUNA-AWARENESS

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 2,983건 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 FOETAL EXPOSURE DURING PREGNANCY443
  2. 2 MATERNAL EXPOSURE DURING PREGNANCY432
  3. 3 약효 없음drug ineffective401
  4. 4 EXPOSURE DURING PREGNANCY361
  5. 5 PREMATURE BABY206
  6. 6 저혈압hypotension191
  7. 7 적응증 외 사용off label use191
  8. 8 PREMATURE DELIVERY160
  9. 9 POSTPARTUM HAEMORRHAGE144
  10. 10 DRUG EXPOSURE DURING PREGNANCY143
  11. 11 MATERNAL EXPOSURE DURING DELIVERY134
  12. 12 CAESAREAN SECTION105

미국 리콜 기록

FDA 리콜(회수) 기록 1건 중 최근 1건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2012.07.25 · 3등급(경미) · JHP Pharmaceuticals, LLC Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".

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.