Label Changes for:

Dantrium (dantrolene sodium) Oral Capsule

July 2012

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

 

BOXED WARNING

  • 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 concomitantpotentially hepatotoxic medications.

WARNINGS

Geriatric Use
  • Clinical studies of Dantrium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in the literature has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. As with all patients receiving Dantrium, it is recommended that elderly patients receive the lowest dose compatible with the optimal response. 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.
Drug Interactions
  • Drowsiness may occur with Dantrium therapy, and the concomitant administration of CNS depressants such as sedatives and tranquilizing agents may result in further drowsiness. Cardiovascular collapse in patients treated simultaneously with verapamil and dantrolene sodium is rare. Administration of Dantrium may potentiate vecuronium-induced neuromuscular block.


PRECAUTIONS

  • Dantrium should be used with caution in patients with impaired pulmonary function, particularly those with obstructive pulmonary disease, and in patients with severely impaired cardiac function due to myocardial disease. Dantrium is associated with pleural effusion with associated eosinophilia. It should be used with caution in patients with a history of previous liver disease or dysfunction.

ADVERSE REACTIONS

Gastrointestinal
  • Constipation rarely progressing to signs of intestinal obstruction, ...nausea and/or vomiting.
Neurologic

 

  • Drooling

Cardiovascular

 

  • heart failure

Hematologic

 

  • Aplastic anemia, anemia, leukopenia, lymphocytic lymphoma, thrombocytopenia

Respiratory

 

  • respiratory depression

Hypersensitivity

 

  • pleural effusion with associated eosinophilia

The published literature has included some reports of Dantrium use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrium capsules are not indicated for the treatment of NMS and patients may expire despite treatment with Dantrium capsules

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