안티마이신연고 효능·효과
안티마이신연고 복용법 (용법·용량)
안티마이신연고 부작용·주의사항
1. 다음 환자에는 투여하지 말 것.
2. 일반적 주의
3. 저장상의 주의사항
안티마이신연고 성분·함량
이 약 1그램 중 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 네오마이신황산염 | Neomycin Sulfate | 3.5 밀리그램 |
📍 안티마이신연고 살 수 있는 내 주변 약국
일반의약품은 처방전 없이 약국에서 살 수 있습니다. 재고는 약국마다 달라 전화로 확인하는 것이 가장 정확합니다.
🗺️ 지도에서 찾기🌐 해외(미국) 정보 — 네오마이신황산염
미국 FDA·NLM 자료 · 2026-09-30 기준이 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Suppression of Intestinal Bacteria Neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ). Hepatic Coma (Portal-Systemic Encephalopathy) Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
OCCUR. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use. NEUROTOXICITY (INCLUDING OTOTOXICITY) AND NEPHROTOXICITY FOLLOWING THE ORAL USE OF NEOMYCIN SULFATE HAVE BEEN REPORTED, EVEN WHEN USED IN RECOMMENDED DOSES. THE POTENTIAL FOR NEPHROTOXICITY, PERMANENT BILATERAL AUDITORY OTOTOXICITY AND SOMETIMES VESTIBULAR TOXICITY IS PRESENT IN PATIENTS WITH NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/OR FOR LONGER PERIODS THAN RECOMMENDED. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). THE RISK OF NEPHROTOXICITY AND OTOTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued. Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, …
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Neomycin sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug. Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Neomycin sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastro- intestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
(SEE BOXED WARNINGS ) Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Risk of Ototoxicity Due to Mitochondrial DNA Variants Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene ( MT-RNR1 ), particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to …
미국 제품명 Antibiotic
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 6,623건 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 약물 과민반응drug hypersensitivity941
- 2 약효 없음drug ineffective936
- 3 통증pain890
- 4 권태감malaise846
- 5 적응증 외 사용off label use810
- 6 발진rash809
- 7 구토vomiting791
- 8 수액 투여 관련 반응infusion related reaction780
- 9 호흡 곤란dyspnoea761
- 10 피로fatigue761
- 11 발열pyrexia752
- 12 제2형 당뇨병type 2 diabetes mellitus693
미국 리콜 기록
FDA 리콜(회수) 기록 6건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2025.05.28 · 2등급 · KENIL HEALTHCARE PRIVATE LIMITED CGMP Deviations
- 2022.09.07 · 2등급 · Teva Pharmaceuticals USA Inc CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
- 2022.06.15 · 2등급 · Mckesson Medical-Surgical Inc. Corporate Office cGMP deviations: Temperature abuse
- 2021.06.02 · 2등급 · Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2019.11.06 · 3등급(경미) · Sandoz Inc Labeling: Incorrect or missing package insert.
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.
허가 정보
- 품목기준코드
- 200600231
- 허가 구분
- 신고 · 완제의약품
- 상태
- 정상
- 저장 방법
- 기밀용기, 실온(1~30℃)보관
- 사용 기간
- 제조일로부터 24 개월
- 포장 단위
- 28그램/튜브
- ATC 코드
- D06AX04
- 표준코드
- 8806448013204, 8806448013211
- 최근 변경
- 2020.08.24
허가 변경 이력
- · 제품명칭변경, 2020-08-24
- · 저장방법 및 유효기간(사용기간)변경, 2020-08-24
- · 저장방법 및 유효기간(사용기간)변경, 2015-08-24
- · 제품명칭변경, 2013-10-15
원문: 식약처 의약품안전나라