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Chlorpromazine Hydrochloride

원료 코드 M223216 국내 제품 4개 (단일제 4 · 복합제 0) DUR 성분 D000584

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이 성분만 든 제품 (단일제 4)

광고

병용금기 성분 (4)

아래 성분이 든 약과 함께 쓰면 안 됩니다 (식약처 DUR).

상대 성분이유
돔페리돈QTc 연장 효과 증대로 심각한 위험(Torsade de Pointes, 심각한 심실성 부정맥 포함) 가능성
아만타딘항콜린작용 증가
에피네프린혈압강하
할로페리돌QT간격 연장 위험 증가

🌐 해외(미국) 정보 — 클로르프로마진염산염

미국 FDA·NLM 자료 · 2026-10-03 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)

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). The extrapyramidal symptoms which can occur secondary to chlorpromazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy. The use of chlorpromazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome. Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. …

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 7,099건 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 약효 없음drug ineffective544
  2. 2 다양한 물질 독성toxicity to various agents459
  3. 3 적응증 외 사용off label use449
  4. 4 과다복용overdose354
  5. 5 약물 상호작용drug interaction327
  6. 6 NEUROLEPTIC MALIGNANT SYNDROME294
  7. 7 오심nausea275
  8. 8 호중구 감소증neutropenia271
  9. 9 설사diarrhoea256
  10. 10 피로fatigue253
  11. 11 구토vomiting251
  12. 12 졸림somnolence241

미국 리콜 기록

FDA 리콜(회수) 기록 20건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2025.09.17 · 2등급 · Zydus Pharmaceuticals (USA) Inc CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
  • 2025.09.17 · 2등급 · Zydus Pharmaceuticals (USA) Inc CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
  • 2025.09.17 · 2등급 · Zydus Pharmaceuticals (USA) Inc CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
  • 2025.09.17 · 2등급 · Zydus Pharmaceuticals (USA) Inc CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
  • 2025.09.17 · 2등급 · Zydus Pharmaceuticals (USA) Inc CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

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.

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