Dantrium® Intravenous

About Dantrium® IV

Dantrium® IV is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium® IV 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® 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.

The Malignant Hyperthermia Association of the United States (MHAUS) recommends stocking a minimum of 36 vials of dantrolene sodium for injection (Dantrium® IV). This number is based on the amount of Dantrium® IV used to treat an average weight patient (70 kg) at the upper dosing limit of 10 mg/kg.1 However, the size of the patient and the severity of the reaction will dictate the number of vials needed.

1 MHAUS. FAQs: Stocking an MH CART. Available at http://www.mhaus.org/faqs/stocking-an-mh-cart. Accessed April 29, 2015.

Important Safety Information

Management of Malignant Hyperthermia (MH) crises requires various supportive measures individualized for the patient's condition. Administration of Dantrium® IV is one component of therapy and should not be considered a substitute for these measures. Even when properly treated, an MH crisis can result in death. Adverse events with Dantrium® IV include loss of grip strength, weakness in the legs, drowsiness, thrombophlebitis, and tissue necrosis/injection site reactions secondary to extravasation. There have been rare reports of pulmonary edema, urticaria and erythema.

View the full Prescribing Information for Dantrium® IV

For more information about Par Sterile Products, please Contact Us.