세폭시틴나트륨

Cefoxitin Sodium

원료 코드 M070626 국내 제품 7개 (단일제 7 · 복합제 0)

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이 성분만 든 제품 (단일제 7)

광고

🌐 해외(미국) 정보 — 세폭시틴나트륨

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)

Treatment Cefoxitin for Injection, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections , including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species. (2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri ). (3) Intra-abdominal infections , including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species. (4) Gynecological infections , including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Streptococcus agalactiae . Cefoxitin for Injection, USP, like cephalosporins, has no activity against Chlamydia trachomatis . Therefore, when Cefoxitin for Injection, USP is used in the treatment of patients with pelvic …

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

INFUSION

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Cefoxitin for Injection is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOXITIN FOR INJECTION OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES. Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including cefoxitin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Pregnancy Reproduction studies performed in rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. In the rabbit, cefoxitin was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit’s unusual …

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 1,373건 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 적응증 외 사용off label use93
  2. 2 DRUG RESISTANCE90
  3. 3 오심nausea80
  4. 4 호산구 증가를 동반한 전신 증상 약물 반응drug reaction with eosinophilia and systemic symptoms79
  5. 5 발진rash77
  6. 6 약효 없음drug ineffective63
  7. 7 미승인 적응증 사용product use in unapproved indication63
  8. 8 THROMBOCYTOPENIA62
  9. 9 증상 악화condition aggravated56
  10. 10 호흡 곤란dyspnoea51
  11. 11 발열pyrexia50
  12. 12 설사diarrhoea49

미국 리콜 기록

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

  • 2014.05.07 · 1등급(심각) · B. Braun Medical Inc Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

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.