단트롤렌나트륨수화물

Dantrolene Sodium Hydrate

원료 코드 M222949 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D001087

🌐 미국 FDA 자료(영문 라벨·부작용 보고·리콜)가 있습니다. 한국어는 AI 번역 참고용이니 원문을 함께 확인하세요. 해외 정보 보기

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이 성분만 든 제품 (단일제 1)

🌐 해외(미국) 정보 — 단트롤렌나트륨수화물

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)

In Chronic Spasticity: Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without Dantrium. Occasionally, subtle but meaningful improvement in spasticity may occur with Dantrium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of Dantrium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of Dantrium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful and/or disabling spasticity such as …

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Dantrium (dantrolene sodium) has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to Dantrium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to Dantrium (dantrolene sodium). Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving Dantrium. However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of Dantrium . Dantrium is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium therapy. At the start of Dantrium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease. If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for Dantrium hepatotoxicity could be enhanced, although such a possibility has not yet been established. Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during Dantrium therapy. If such studies reveal abnormal values, therapy should generally be discontinued. Only where benefits of the drug have been of major importance to the patient, should reinitiation or continuation of therapy be considered. Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, Dantrium should be discontinued. If caused by Dantrium and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Dantrium therapy has been reinstituted in a few patients who have developed clinical and/or laboratory evidence of hepatocellular injury. If such reinstitution of therapy is done, …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Pregnancy: Adequate animal reproduction studies have not been conducted with Dantrium . It is also not known whether Dantrium can cause fatal harm when administered to a pregnant woman or can affect reproduction capacity. Dantrium should be given to a pregnant woman only if clearly needed.

미국 제품명 Dantrium, Revonto, RYANODEX dantrolene sodium

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 1,745건 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 NEUROLEPTIC MALIGNANT SYNDROME172
  2. 2 약효 없음drug ineffective156
  3. 3 적응증 외 사용off label use116
  4. 4 발열pyrexia93
  5. 5 쇠약asthenia78
  6. 6 폐렴pneumonia76
  7. 7 RESPIRATORY FAILURE75
  8. 8 요로 감염urinary tract infection73
  9. 9 구토vomiting68
  10. 10 피로fatigue62
  11. 11 오심nausea59
  12. 12 설사diarrhoea58

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  • 2022.06.15 · 2등급 · Mckesson Medical-Surgical Inc. Corporate Office cGMP deviations: Temperature abuse

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.