테트라사이클린염산염

Tetracycline Hydrochloride

원료 코드 M223235 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D000064

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이 성분만 든 제품 (단일제 1)

병용금기 성분 (4)

아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).

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🌐 해외(미국) 정보 — 테트라사이클린염산염

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).

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae . Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. Lower respiratory tract infections caused by Streptococcus pyogenes , Streptococcus pneumoniae , Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp. ) Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus . (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. Psittacosis caused by Chlamydophila psittaci . Infections caused by Chlamydia …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Tooth Development The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including tetracyclines, 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 antibacterial drugs. 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 use of antibacterial drugs not directed against C. …

미국 제품명 Viaderma Vitastem First Aid Topical Antibiotic, Vitastem-tetracycline hydrochloride, ViaDerma Care Tetracycline HCl First Aid Antibiotic, Vitastem First Aid Antibiotic, Honestly Battleborn First Aid for Real Man, Vitastem, Tetracyte Topical Tetracycline Hydrochloride, Viabecline

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 1,882건 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 use289
  2. 2 오심nausea208
  3. 3 설사diarrhoea169
  4. 4 구토vomiting166
  5. 5 약물 과민반응drug hypersensitivity162
  6. 6 두통headache160
  7. 7 어지러움dizziness147
  8. 8 과민반응hypersensitivity140
  9. 9 쇠약asthenia131
  10. 10 피로fatigue125
  11. 11 관절통arthralgia120
  12. 12 사지통pain in extremity119

미국 리콜 기록

FDA 리콜(회수) 기록 2건 중 최근 2건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2020.04.15 · 1등급(심각) · Avet Pharmaceuticals, Inc. Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
  • 2020.04.15 · 1등급(심각) · Avet Pharmaceuticals, Inc. Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

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.