Dantrium® Intravenous dantrolene sodium for injection USP

INDICATIONS AND CLINICAL USE: 

 

Dantrium (dantrolene sodium) Intravenous is indicated in the management of malignant hyperthermia crisis.

 

As soon as the crisis is recognized (i.e., tachycardia, tachypnea, central venous desaturation, central venous hypercarbia, metabolic acidosis, fever, skeletal muscle rigidity or cyanosis and mottling of the skin) cooling procedures should be instituted and Dantrium Intravenous administered.  If anesthetic agents are being administered they should be promptly discontinued.  It is also important that appropriate supportive measures be instituted for treatment of the physiologic and metabolic abnormalities.  Dantrium Intravenous, when given early in the malignant hyperthermia crisis, has caused abrupt lowering of body temperature, correction of the respiratory and/or metabolic acidosis, decrease of the heart rate, stabilization of blood pressure, and disappearance of the rigidity and/or fasciculations.  Patients who received Dantrium Intravenous during the crisis had less evidence of muscle destruction as shown by serum creatinine phosphokinase measurements than those treated by other measures.

 

CONTRAINDICATIONS: 

 

There are no known contraindications when Dantrium (dantrolene sodium) Intravenous is used during an acute malignant hyperthermia crisis.

 

WARNINGS: 

 

General: The use of dantrolene sodium intravenous in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures.  These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Please see complete warnings and full prescribing information for further information.

 

ADVERSE REACTIONS: The more serious reactions reported with repeated doses of oral Dantrium (dantrolene sodium) as a muscle relaxant have been hepatitis, seizures and pleural effusions with pericarditis. Cases of fatal hepatitis have been reported in patients who had received Dantrium for sixty days or longer. Symptomatic hepatitis and laboratory evidence of liver dysfunction have also been reported in a number of patients receiving Dantrium as a muscle relaxant. Acneiform skin reactions have also been infrequently reported. For a list of adverse reactions reported with the use of Dantrium as a muscle relaxant, please consult the Product Monograph for Dantrium Capsules.

 

The administration of intravenous dantrolene sodium to human volunteers is associated with loss of grip strength and weakness in the legs, as well as subjective central nervous system complaints.

 

Based upon data in human volunteers, it will sometimes be appropriate to tell patients who receive dantrolene sodium intravenous that decrease in grip strength and weakness of leg muscles, especially walking down stairs, can be expected postoperatively. In addition, symptoms such as “lightheadedness” may be noted. Since some of these symptoms may persist for up to 48 hours, patients must not operate an automobile or engage in other hazardous activity during this time. Caution is also indicated at meals on the day of administration because difficulty swallowing and choking have been reported. Caution should be exercised in the concomitant administration of tranquilizing agents.

 

AVAILABILITY:  Dantrium Intravenous is available in 70 mL vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted.  These are not multiple dose vials.  Available in cartons of 6 vials.

 

Dantrium Intravenous is available only for use in hospitals or in dental clinics that are equipped to provide the necessary supportive measures used in the treatment of the malignant hyperthermia crisis.

 

Carton of 6 vials

DIN 01997572

 

For full prescribing information please refer to the Product Monograph

 

 

Dantrium IV

 

Methapharm is committed to assisting health care practitioners with the treatment of malignant hyperthermia (MH), a life-threatening genetic disorder.