Revonto ™ (dantrolene sodium for injection)

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Dosage and Administration

DOSING CHART
Weight of Patient   Required Number of Revonto Vials
kg lbs 1 mg/kg 2 mg/kg 2.5 mg/kg* 4 mg/kg 6 mg/kg 8 mg/kg 10 mg/kg
10 22 0.5 1 1.3 2 3 4 5
15 33 0.8 1.5 1.9 3 4.5 6 7.5
25 55 1.3 2.5 3.1 5 7.5 10 12.5
35 77 1.8 3.5 4.4 7 10.5 14 17.5
50 110 2.5 5 6.3 10 15 20 25
65 143 3.3 6.5 8.1 13 19.5 26 32.5
80 176 4 8 10 16 24 32 40
95 209 4.8 9.5 11.9 19 28.5 38 47.5
110 242 5.5 11 13.8 22 33 44 55
125 275 6.3 12.5 15.6 25 37.5 50 62.5
140 308 7 14 17.5 28 42 56 70
155 341 7.8 15.5 19.4 31 46.5 62 77.5
165 364 8.3 16.5 20.6 33 49.5 66 82.5

Dosage and Administration

As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued; the administration of 100% oxygen is recommended. Revonto should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.

If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to note that administration of Revonto 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 Revonto for pediatric patients is the same as for adults.

Preoperatively: Revonto and/or dantrolene sodium 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.

Revonto: The recommended prophylactic dose of Revonto is 2.5 mg/kg, starting approximately 1.25 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.

Additional Revonto may be indicated during anesthesia and surgery because of the appearance of early clinical and/or blood gas signs of malignant hyperthermia or because of prolonged surgery (see also CLINCAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS). Additional doses must be individualized.

Oral Administration of Dantrolene Sodium Capsules: Administer 4 to 8 mg/kg/day of oral dantrolene sodium 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 dantrolene sodium capsules.

Post Crisis Follow-Up: Dantrolene sodium 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 dantrolene sodium may be used postoperatively to prevent or attenuate the recurrence of signs of malignant hyperthermia when oral dantrolene sodium administration is not practical. The i.v. dose of dantrolene sodium in the postoperative period must be individualized, starting with 1 mg/kg or more as the clinical situation dictates.

Please see full prescribing information for Revonto.

 

Indication

Revonto is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. It 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.

Important Safety Information

The use of Revonto 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. Patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored.

If patients judged malignant hyperthermia susceptible are administered dantrolene sodium preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible.

Despite initial satisfactory response to i.v. dantrolene there have been reports of fatality, which involve patients who could not be weaned from dantrolene after initial treatment. The administration of i.v. dantrolene is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness. There have been reports of thrombophlebitis following administration of intravenous dantrolene. Tissue necrosis secondary to extravasation has been reported. Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.

To report SUSPECTED ADVERSE REACTIONS contact US WorldMeds at 1-888-900-8796 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088)
or http://www.FDA.gov/medwatch/.

For additional information, see full prescribing information for Revonto.