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Dantrium (Dantrolene Sodium) - Summary

 
 



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). Dantrium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of Dantrium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

 

DANTRIUM SUMMARY

Dantrium® (dantrolene sodium) capsules

Dantrium (dantrolene sodium) is a muscle relaxant.

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 clonus, or

permits a significant reduction in the intensity and/or degree of nursing care required, or

rids the patient of any annoying manifestation of spasticity considered important by the patient himself.

In Malignant Hyperthermia: Oral Dantrium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous dantrolene sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous.

Oral Dantrium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.


See all Dantrium indications & dosage >>

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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