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루파타딘푸마르산염

Rupatadine Fumarate

원료 코드 M118314 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)

루파핀정(루파타딘푸마르산염) 사진 루파핀정(루파타딘푸마르산염) 안국약품(주)· 항히스타민제· 12.8밀리그램· 2017년 허가 전문

🌐 해외(미국) 정보 — 루파타딘푸마르산염

미국 FDA·NLM 자료 · 2026-10-07 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)

Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES ( 14.1 )]. 1.2 Bipolar Disorder Quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see CLINICAL STUDIES ( 14.2 )]. Quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see CLINICAL STUDIES ( 14.2 )]. Quetiapine tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. …

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. 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. Quetiapine is not approved for elderly patients with dementia-related psychosis ( 5.1 ) Suicidal Thoughts and Behaviors Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants ( 5.2 ) Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.2 ) WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS 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 [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Known hypersensitivity to quetiapine or any components in the formulation. ( 4 ) Hypersensitivity to quetiapine or to any excipients in the quetiapine tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine tablets.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs ( 5.3 ) Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring ( 5.4 ) Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain ( 5.5 ) Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.6 ) Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease ( 5.7 ) Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents ( 5.9 ) Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs (including quetiapine) during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see CLINICAL CONSIDERATIONS ). Overall available data from published …

미국 제품명 Quetiapine fumarate, Tenofovir Disoproxil Fumarate, VOQUEZNA, Formoterol Fumarate, Ibutilide Fumarate, Bisoprolol Fumarate, Dimethyl Fumarate, KETOTIFEN FUMARATE

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 527,586건 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 호흡 곤란dyspnoea35,942
  2. 2 약효 없음drug ineffective27,528
  3. 3 피로fatigue26,883
  4. 4 오심nausea26,145
  5. 5 설사diarrhoea24,049
  6. 6 통증pain23,287
  7. 7 BONE DENSITY DECREASED20,427
  8. 8 두통headache20,273
  9. 9 FLUSHING20,067
  10. 10 적응증 외 사용off label use19,635
  11. 11 구토vomiting17,751
  12. 12 어지러움dizziness17,525

미국 리콜 기록

FDA 리콜(회수) 기록 12건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2026.02.11 · 2등급 · Unichem Pharmaceuticals USA Inc. cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
  • 2026.01.14 · 3등급(경미) · Alembic Pharmaceuticals Limited Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
  • 2025.11.26 · 3등급(경미) · Alembic Pharmaceuticals Limited Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
  • 2022.08.17 · 2등급 · Mckesson Medical-Surgical Inc. Corporate Office CGMP Deviations: products were stored outside the drug label specifications.
  • 2021.06.02 · 2등급 · Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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.