Dantrolene Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Malignant Hyperthermia

For preoperative to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be susceptible:

IV: 2.5 mg/kg IV, starting approximately 75 minutes before anticipated anesthesia and infused over approximately 1 hour. This dose should be effective provided that the usual precautions, such as avoidance of established malignant hyperthermia triggering agents, are followed. Additional IV dantrolene may be indicated during anesthesia and surgery because of the appearance of early clinical and/or blood gas signs of malignant hyperthermia or because of prolonged surgery. Additional doses must be individualized.

Oral: 4 to 8 mg/kg/day orally in three or four divided doses for 1 or 2 days prior to surgery, with the last dose being given with a minimum of water approximately 3 to 4 hours before scheduled surgery. Adjustment can usually be made within the recommended dosage range to avoid incapacitation (weakness, drowsiness, etc.) or excessive gastrointestinal irritation (nausea and/or vomiting).

For postoperative use to prevent or attenuate the recurrence of signs of malignant hyperthermia when oral administration is not practical:

IV: dose must be individualized, starting with 1 mg/kg or more as the clinical situation dictates.

For use in the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crisis:

IV: (Starting dose = Minimum Dose) 1 mg/kg administered by continuous rapid intravenous push and continued until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.

As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued. The administration of 100% oxygen is also recommended.

If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to emphasize that administration of dantrolene intravenous should be continuous until symptoms subside. The effective dose to reverse the crisis is directly dependent upon the individual's degree of susceptibility to malignant hyperthermia, the amount and time of exposure to the triggering agent, and the time elapsed between onset of the crisis and initiation of treatment.

Oral: 4 to 8 mg/kg/day orally in four divided doses administered for 1 to 3 days following a malignant hyperthermia crisis to prevent recurrence of the manifestations of malignant hyperthermia.

Usual Adult Dose for Chronic Spasticity

For use in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders:

25 mg orally once daily for 7 days, then
25 mg three times a day for 7 days, then
50 mg three times a day for 7 days, then
100 mg three times a day.

Prior to administration, consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with dantrolene.

It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning dantrolene therapy.

Dosage should be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended.

Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.

Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used.

In view of the potential for liver damage in long-term dantrolene use, therapy should be stopped if benefits are not evident within 45 days.

Usual Pediatric Dose for Malignant Hyperthermia

For preoperative to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be susceptible:

IV: 2.5 mg/kg IV, starting approximately 75 minutes before anticipated anesthesia and infused over approximately 1 hour. This dose should be effective provided that the usual precautions, such as avoidance of established malignant hyperthermia triggering agents, are followed. Additional IV dantrolene may be indicated during anesthesia and surgery because of the appearance of early clinical and/or blood gas signs of malignant hyperthermia or because of prolonged surgery. Additional doses must be individualized.

Oral: 4 to 8 mg/kg/day orally in three or four divided doses for 1 or 2 days prior to surgery, with the last dose being given with a minimum of water approximately 3 to 4 hours before scheduled surgery. Adjustment can usually be made within the recommended dosage range to avoid incapacitation (weakness, drowsiness, etc.) or excessive gastrointestinal irritation (nausea and/or vomiting).

For postoperative use to prevent or attenuate the recurrence of signs of malignant hyperthermia when oral administration is not practical:

IV: dose must be individualized, starting with 1 mg/kg or more as the clinical situation dictates.

For use in the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crisis:

IV: (Starting dose = Minimum Dose) 1 mg/kg administered by continuous rapid intravenous push and continued until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.

As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued. The administration of 100% oxygen is also recommended.

If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to emphasize that administration of dantrolene intravenous should be continuous until symptoms subside. The effective dose to reverse the crisis is directly dependent upon the individual's degree of susceptibility to malignant hyperthermia, the amount and time of exposure to the triggering agent, and the time elapsed between onset of the crisis and initiation of treatment.

Oral: 4 to 8 mg/kg/day orally in four divided doses administered for 1 to 3 days following a malignant hyperthermia crisis to prevent recurrence of the manifestations of malignant hyperthermia.

Usual Pediatric Dose for Chronic Spasticity

For use in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders: 0.5 mg/kg orally once daily for 7 days, then
0.5 mg/kg three times a day for 7 days, then
1 mg/kg three times a day for 7 days, then
2 mg/kg three times a day.

Dosage should be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended.

Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose.

Therapy with a dose four times daily may be necessary for some individuals. Doses higher than 100 mg four times daily should not be used.

In view of the potential for liver damage in long-term dantrolene use, therapy should be stopped if benefits are not evident within 45 days.

Liver Dose Adjustments

Active hepatic disease (including hepatitis and cirrhosis) is a contraindication to the use of dantrolene.

Precautions

Dantrolene is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to attain or maintain increased function.

Caution is recommended if the drug is to be used in patients with impaired pulmonary function, particularly those with obstructive pulmonary disease, and in patients with severely impaired cardiac function due to myocardial disease.

Other Comments

Frequent monitoring of hepatic function, including SGOT and SGPT levels, is recommended. Due to the risk of hepatotoxicity, the lowest possible effective dose should always be used. If benefit from the use of dantrolene has not been observed within 45 days, then discontinuation of therapy is recommended.

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