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Dantrium (Dantrolene Sodium) - Summary

 
 



DANTRIUM SUMMARY

Dantrium Intravenous is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium Intravenous is supplied in 70 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 mL sterile water for injection USP (without a bacteriostatic agent). Dantrium is classified as a direct-acting skeletal muscle relaxant.

Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).

Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.


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NEWS HIGHLIGHTS

Published Studies Related to Dantrium (Dantrolene)

The efficacy of dantrolene sodium in controlling exertional rhabdomyolysis in the Thoroughbred racehorse. [2003.11]
REASONS FOR PERFORMING STUDY: Dantrolene sodium (Dantrium) has been used extensively for the treatment of myopathies in man and anecdotal evidence suggests it is of clinical benefit in the control of exercise-induced rhabdomyolysis (ER) in racehorses, although data to support this are currently lacking. OBJECTIVES: To investigate the efficacy of oral dantrolene sodium in controlling ER in a randomised, double-blind, placebo-controlled crossover trial involving 77 Thoroughbred racehorses in Newmarket, UK... CONCLUSIONS: The results confirmed that oral administration of dantrolene sodium, 1 h before exercise, had a statistically significant effect on reducing the difference between pre- and post exercise plasma CK levels compared with a placebo in the same animals, and preventing clinical ER in susceptible individuals. POTENTIAL RELEVANCE: This study suggested that dantrolene sodium is of use in controlling ER in the Thoroughbred racehorse. Further investigation into pre- and post exercise myoplasmic calcium levels and the repeat of the study late in the season when horses receive a much higher energy ration and more strenuous exercise would appear to be warranted.

Dantrolene, an inhibitor of intracellular calcium release, fails to increase survival in a rat model of intra-abdominal sepsis. [1996.09]
OBJECTIVE: Increased release of intracellular calcium has been implicated in cell death and organ failure in endotoxemia and sepsis. We sought to test this hypothesis in a rat model of antibiotic-treated intraperitoneal sepsis with the use of dantrolene sodium, a specific inhibitor of intracellular calcium release... CONCLUSIONS: We conclude that dantrolene decreases survival in bacterial sepsis and has no effect on survival in endotoxemia in rats. The importance of excessive intracellular calcium release in sepsis remains to be elucidated.

Objective assessment of spasticity, strength, and function with early exhibition of dantrolene sodium after cerebrovascular accident: a randomized double-blind study. [1992.01]
A double-blind, placebo-controlled trial was conducted to determine whether early exhibition of Dantrium (Dantrolene Sodium) in patients with cerebrovascular accidents, before the onset of significant spasticity, would enhance the functional outcome of rehabilitation...

Ineffectiveness of dantrolene sodium in the treatment of heatstroke. [1991.02]
STUDY OBJECTIVE: To determine the efficacy of dantrolene sodium in the treatment of heatstroke... CONCLUSION: Treatment with dantrolene sodium at the dose used, did not prove beneficial to patients with heatstroke.

Dantrolene sodium does influence the second-wind phenomenon in McArdle's disease. Electrophysiological evidence during exercise in a double-blind placebo-controlled, cross-over study in 5 patients. [1990.12]
Five patients with McArdle's disease entered a double-blind, placebo-controlled, cross-over study of dantrolene sodium... Quite unexpectedly however, in view of the negative clinical results, this electrophysiological manifestation of muscle fatigue during the adaptation phase diminished or disappeared in all patients investigated when dantrolene sodium was used.

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Clinical Trials Related to Dantrium (Dantrolene)

Safety Study of Dantrolene in Subarachnoid Hemorrhage [Recruiting]
Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.

Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. However, the first human studies have only been observational and over a short period of time.

This study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cVSP after SAH. The goal is to determine if future efficacy studies should be done to determine if treatment with Dantrolene may improve the outcome of patients with cVSP after SAH.

Dantrolene for Treatment of Hyperthermia in Subarachnoidal Hemorrhage (SAH) [Recruiting]

Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage [Recruiting]
Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.

Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.

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Reports of Suspected Dantrium (Dantrolene) Side Effects

OFF Label USE (10)Infusion Site Irritation (6)Vomiting (6)Acne (6)Altered State of Consciousness (6)Pyrexia (4)Condition Aggravated (4)Drug Ineffective (3)Diplopia (3)Eye Movement Disorder (3)more >>


Page last updated: 2006-01-31

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