A frequently asked question is why normal saline cannot be used to reconstitute Dantrolene Sodium for Injection (DS-IV) despite the fact that it possesses approximately the same pH as the recommended sterile water for injection.

US WorldMeds, one of the manufacturers of DS-IV, has launched an investigation to answer this scientific question.

Upon the introduction of 60 mL of sterile normal saline into DS-IV vials, a cloudy (milky) suspension is formed indicating the formation of insoluble particles. Centrifugation with subsequent filtration of the particles resulted in their isolation. The separated precipitate was shown to be the sodium salt of dantrolene when tested by high performance liquid chromatography (HPLC) and elemental analysis for sodium. Importantly, the supernatant solution resulting from filtration of the DS-IV suspension, was shown to exhibit a loss of 40 ± 5% of its strength by HPLC analysis (i.e., a substantial reduction of its dantrolene content). These data indicate that the administration of DS-IV reconstituted with normal saline to MH patients not only represents a treatment with a preparation of reduced strength but also results in the administration of a heterogeneous suspension containing insoluble particles. Further, when the DS-IV was reconstituted with 60 mL of normal saline (235-240 mOsm/L), it resulted in a hypertonic product possessing an osmolarity of 526 ± 0.5 mOsm/L which is twice as great as the osmolarity of DS-IV reconstituted with sterile WFI (261 ± 2.1 mOsm/L). In our opinion, this is an added important reason for avoiding the reconstitution of DS-IV product with normal saline. As a consequence, the greater the number of vials utilized to treat MH, the larger the volume of the hypertonic solution will be introduced into the blood stream of patients, should sterile normal saline be used as a reconstitution vehicle as opposed to using sterile WFI.

Further research is being conducted by US WorldMeds to fully understand the above phenomena. Click here for full article on SCIENTIFIC REASONS WHY NORMAL SALINE CANNOT BE USED…

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Please see complete prescribing information for Dantrolene Sodium for Injection.

For More information on Malignant Hyperthermia please visit The Malignant Hyperthermia Association of the United States (MHAUS).

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