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Dantrolene - Dantrium ®
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| [20 mg vial] [60 ml sterile water without a bacteriostatic agent]
Infusion rate: as directed
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
Stability / Miscellaneous
Dantrium is given by direct injection and is incompatible with D5W or NS.
EXP: 6hours (RT).
Treatment of severe muscle rigidity: 1 mg/kg rapid iv push, may repeat q1-3min until muscle relaxation or total dose of 10 mg/kg. When patient can tolerate po may substitute 1-2 mg/kg po qid. If refractory (NMS) consider adding bromocriptine 5 mg tid initially -if response is inadequate, increase dose rapidly to max of 10-20 mg po q6h. D/C when patient improves or CPK (normal).
Prevention of malignant hyperthermia: 2.5 mg/kg IV over 1 hr approximately 75 minutes prior
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to note that administration of Dantrium 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.
Pediatric Dose: Experience to date indicates that the dose of Dantrium Intravenous for pediatric patients is the same as for adults.
Preoperatively: Dantrium Intravenous and/or Dantrium Capsules may be administered preoperatively to patients judged malignant hyperthermia susceptible as part of the overall patient management to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia.
Dantrium Intravenous: The recommended prophylactic dose of Dantrium Intravenous is 2.5 mg/kg, starting approximately 1-1/4 hours before anticipated anesthesia and infused over approximately 1 hour. This dose should prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia provided that the usual precautions, such as avoidance of established malignant hyperthermia triggering agents, are followed.
Oral Administration of Dantrium Capsules: Administer 4 to 8 mg/kg/day of oral Dantrium 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). See also the package insert for Dantrium Capsules.
Post Crisis Follow-Up: Dantrium Capsules, 4 to 8 mg/kg/day, in four divided doses should be administered for 1 to 3 days following a malignant hyperthermia crisis to prevent recurrence of the manifestations of malignant hyperthermia.
Intravenous Dantrium may be used postoperatively to prevent or attenuate the recurrence of signs of malignant hyperthermia when oral Dantrium administration is not practical. The i.v. dose of Dantrium in the postoperative period must be individualized, starting with 1 mg/kg or more as the clinical situation dictates.
Reconstituted Dantrium Intravenous should not be transferred to large glass bottles for prophylactic infusion due to precipitate formation observed with the use of some glass bottles as reservoirs.
For prophylactic infusion, the required number of individual vials of Dantrium Intravenous should be reconstituted as outlined above. The contents of individual vials are then transferred to a larger volume sterile intravenous plastic bag. Stability data on file at Procter & Gamble Pharmaceuticals indicate commercially available sterile plastic bags are acceptable drug delivery devices. However, it is recommended that the prepared infusion be inspected carefully for cloudiness and/or precipitation prior to dispensing and administration. Such solutions should not be used. While stable for 6 hours, it is recommended that the infusion be prepared immediately prior to the anticipated dosage administration time.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Store unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light.
Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006.
Mfg. by: Ben Venue Laboratories