테트라데실황산나트륨콘센트레이트
Sodium Tetradecyl Sulfate Concentrate
원료 코드 M089182 국내 제품 4개 (단일제 4 · 복합제 0) DUR 성분 D000183
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이 성분만 든 제품 (단일제 4)
광고
🌐 해외(미국) 정보 — 테트라데실황산나트륨콘센트레이트
미국 FDA·NLM 자료 · 2026-10-04 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)
Sodium tetradecyl sulfate injection is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit- to-risk ratio should be considered in selected patients who are great surgical risks.
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
Sodium tetradecyl sulfate injection is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Sodium tetradecyl sulfate injection should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Emergency resuscitation equipment should be immediately available. Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of sodium tetradecyl sulfate injection be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately. Because of the danger of thrombosis extension into the deep venous system, thorough preinjection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Teratogenic Effects Animal reproduction studies have not been conducted with sodium tetradecyl sulfate injection. It is also not known whether sodium tetradecyl sulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium tetradecyl sulfate injection should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.
미국 제품명 (SOTRADECOL) SODIUM TETRADECYL SULFATE
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 53건 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 적응증 외 사용off label use7
- 2 미승인 적응증 사용product use in unapproved indication5
- 3 AIR EMBOLISM3
- 4 DEEP VEIN THROMBOSIS3
- 5 DISEASE PROGRESSION3
- 6 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION3
- 7 ISCHAEMIC STROKE3
- 8 통증pain3
- 9 ACUTE MYOCARDIAL INFARCTION2
- 10 ACUTE RESPIRATORY FAILURE2
- 11 ADVERSE REACTION2
- 12 ANAPHYLACTIC REACTION2
미국 리콜 기록
FDA 리콜 기록이 없습니다.
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.
