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구연산제이철수화물

Ferric Citrate Hydrate

원료 코드 M282661 국내 제품 1개 (단일제 1 · 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 1)

네폭실캡슐500mg(구연산제이철수화물) 사진 네폭실캡슐500mg(구연산제이철수화물) (주)엘지화학· 기타의 순환계용약· 2022년 허가 전문

🌐 해외(미국) 정보 — 구연산제이철수화물

미국 FDA·NLM 자료 · 2026-10-06 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)

Auryxia is a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Auryxia is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. ( 1 ) 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis Auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. 1.2 Iron Deficiency Anemia in Chronic Kidney Disease Not on Dialysis Auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see Warnings and Precautions ( 5.1 )] . Iron overload syndromes (e.g., hemochromatosis). ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Iron overload: Monitor ferritin and TSAT. Patients may require a reduction in dose or discontinuation of intravenous iron. ( 5.1 ) Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. ( 5.2 ) 5.1 Iron Overload Iron absorption from Auryxia may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial evaluating the control of serum phosphate levels in patients with chronic kidney disease on dialysis in which concomitant use of intravenous iron was permitted, 55 (19%) of patients treated with Auryxia had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control. Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Auryxia and monitor iron parameters while on therapy [see Contraindications ( 4 ), Overdosage ( 10 ) and Clinical Pharmacology ( 12.2 )] . Patients receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy. 5.2 Risk of Overdosage in Children Due to Accidental Ingestion Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age [see Overdosage ( 10 )] . Advise …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Risk Summary There are no available data on Auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted using Auryxia. Skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. However, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats caused no fetal malformation. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. The estimated background risk of major birth defects …

미국 제품명 Auryxia

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 2,194건 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 설사diarrhoea307
  2. 2 SERUM FERRITIN INCREASED228
  3. 3 TRANSFERRIN SATURATION INCREASED169
  4. 4 FAECES DISCOLOURED118
  5. 5 사망death112
  6. 6 변비constipation83
  7. 7 오심nausea70
  8. 8 약효 없음drug ineffective69
  9. 9 구토vomiting65
  10. 10 만성 신장병chronic kidney disease59
  11. 11 말기 신장병end stage renal disease58
  12. 12 소양증pruritus55

미국 리콜 기록

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

  • 2021.06.02 · 2등급 · Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
  • 2020.12.30 · 2등급 · Akebia Therapeutics dba Keryx Biopharmaceutials, Inc CGMP Deviations
  • 2020.07.22 · 2등급 · Keryx Biopharmaceuticals, Inc. cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
  • 2018.01.03 · 3등급(경미) · Keryx Biopharmaceuticals, Inc. Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

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.