TREATMENT USING DANTROLENE

摘要

Provided are low-volume, safe for injection formulations of dantrolene yielding significant advantages over the currently approved and marketed dantrolene for malignant hyperthermia (MH) threatening anesthetic crisis. Once dantrolene can be made immediately available to patients triggered of MH, the anesthesiologist will be able to focus exclusively on the management of the patient's physiologic status in this complex and evolving crisis, not on the laborious and time consuming reconstitution process of the rescue agent. The low volume, safe for injection formulations of dantrolene have significant advantages over currently used approaches to the prevention and treatment of pumphead, and other neurological, cognitive and motor dysfunction incident to iatrogenically or trauma induced situations of altered blood flow, including those incurred during surgical procedures involving CPB or related procedures, as well as those incurred during non-normothermic episodes caused iatrogenically or by disease.

主权项

1. A method for treating postperfusion syndrome (pumphead) in a mammal, comprising the step of:
administering to a mammal in need of treatment for postperfusion syndrome a therapeutically effective amount of a safe for injection, low volume liquid formulation of dantrolene sodium comprising:
dantrolene sodium at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml;a water-soluble polysorbate;a compound selected from the group consisting of sorbitol and mannitol; andwater as a liquid carrier,wherein said dantrolene sodium and water are present together as a colloidal dispersion of dantrolene sodium particles in the water,wherein the dantrolene sodium particles are less than about 2 microns in average diameter, andwherein the formulation is safe for intravenous administration.