title: Safety of low-dose oral dantrolene sodium on hepatic function.
abstract: OBJECTIVE
  To investigate the incidence of hepatobiliary dysfunction after administration of low-dose dantrolene sodium.
  
  
  METHODS
  A retrospective survey of medical records.
  
  
  METHODS
  One secondary and 2 tertiary hospitals.
  
  
  METHODS
  Patients (N=243; 144 men, 27 children; mean age ± SD, 47.8 ± 19.7y) who were administered dantrolene at a daily dose of 12.5 to 400mg for more than 4 weeks.
  
  
  METHODS
  Not applicable.
  
  
  METHODS
  Liver function test (LFT) results, including serum total bilirubin, aspartate transaminase, alanine transaminase, and alkaline phosphatase, were recorded before and at least 1 month after the initial dose of dantrolene. In cases of treatment cessation, the reason was investigated. Significantly elevated LFT levels were defined as ≥ to 2 times the upper limit of the normal range.
  
  
  RESULTS
  Treatment duration was 268.0 ± 428.5 days with a daily dose of 65.2 ± 44.7 mg. At the end of the investigation, 95 patients (39.1%) had been lost to follow-up, and 105 (43.2%) had stopped treatment. The reasons for cessation were improved spasticity (42.9%), no effect of the medication (27.6%), weakness (6.7%), and other medical problems (5.7%). Patients with weaknesses did not have elevated LFT values. A 32-year-old man with head injuries and multiple trauma developed hepatic dysfunction 82 days after the initial dose and 43 days after a dose increment to 400mg/d. Other patients did not experience significant LFT abnormalities.
  
  
  CONCLUSIONS
  One case of hepatic dysfunction was recorded in 243 cases after at least 4 weeks of low-dose oral dantrolene administration. Low-dose dantrolene can be used safely with meticulous clinical and laboratory monitoring.
authors: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors: Jung Yoon
authors: JY
authors: Kim
authors: Sewoong
authors: S
authors: Chun
authors: Moon Suk
authors: MS
authors: Bang
authors: Hyung-Ik
authors: HI
authors: Shin
authors: Shi-Uk
authors: SU
authors: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology / Q000503:physiopathology*; D002648:Child; D002675:Child, Preschool; D003620:Dantrolene / Q000008:administration & dosage* / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009125:Muscle Relaxants, Central / Q000008:administration & dosage* / Q000009:adverse effects*; D012189:Retrospective Studies; D013997:Time Factors
chemical_list: D009125:Muscle Relaxants, Central; D003620:Dantrolene