Dantrolene (Page 3 of 3)

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. Dantrolene Sodium for Injection 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 Dantrolene Sodium for Injection 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 Dantrolene Sodium for Injection for pediatric patients is the same as for adults.

Preoperatively

Dantrolene Sodium for Injection 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.

The recommended prophylactic dose of Dantrolene Sodium for Injection 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.

Additional Dantrolene Sodium for Injection 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 CLINICAL PHARMACOLOGY , WARNINGS , and PRECAUTIONS ). Additional doses must be individualized.

Oral Administration of Dantrolene Oral 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, USP.

Post Crisis Follow-Up

Dantrolene Sodium Capsules, 4 to 8 mg/kg/day, in four divided doses should be administered 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 intravenous 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 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 until the solution is clear. 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection USP, and other acidic solutions are not compatible with Dantrolene Sodium for Injection 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 solutions at controlled room temperature (59°F to 86°F or 15°C to 30°C).

Reconstituted Dantrolene Sodium for Injection 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 Dantrolene Sodium for Injection 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.

HOW SUPPLIED

Dantrolene Sodium for Injection, USP (NDC 0143-9297-01) is available in vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3,000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 mL sterile water for injection USP (without a bacteriostatic agent).

Store reconstituted solution at 20° to 25°C (68º to 77°F) [See USP Controlled Room Temperature].

Protect from direct light.

Store unreconstituted product at 20° to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. Avoid prolonged exposure to light.

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 – Terrugem Sintra, Portugal

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Revised: August 2020

PIN474-WES/3

PRINCIPAL DISPLAY PANEL

NDC 0143-9297 -01 Rx only
Dantrolene
Sodium for
Injection, USP
20 mg per vial
For treatment of malignant hyperthermia
For Intravenous use ONLY
Single Dose Vial

Dantrolene 20mg vial
(click image for full-size original)

NDC 0143-9297 -01 Rx only
Dantrolene
Sodium for Injection, USP
20 mg per vial
For treatment of malignant hyperthermia
For Intravenous use ONLY
1 Single Dose Vial, 20 mg in each vial

Dantrolene 20mg carton
(click image for full-size original)

SERIALIZATION IMAGE

LAYOUT 1LAYOUT 1
DANTROLENE
dantrolene injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9297
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANTROLENE SODIUM (DANTROLENE) DANTROLENE SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL 3000 mg
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9297-01 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204762 06/19/2017
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 02/2022 Hikma Pharmaceuticals USA Inc.

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