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Revonto Injection Dosage

Generic name: dantrolene sodium 20mg in 60mL
Dosage form: injection, powder, lyophilized, for solution

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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.

PREPARATION

Each vial of Revonto (dantrolene sodium for injection) should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken for approximately 20 seconds or until the solution is clear. 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection USP, and other acidic solutions are not compatible with Revonto and should not be used. The contents of the vial must be protected from direct light and used within 6 hours after reconstitution. Store reconstituted solution at 20-25° C (68-77° F) [see USP Controlled Room Temperature] protected from direct light. Each vial of dantrolene sodium for injection should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken for approximately 20 seconds or until the solution is clear.

Reconstituted Revonto 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 Revonto 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 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.

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