Ryanodex Dantrolene Sodium
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
RYANODEX® is indicated for the:
- Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration (2.1)]
- Prevention of malignant hyperthermia in patients at high risk.
History
There is currently no drug history available for this drug.
Other Information
RYANODEX® (dantrolene sodium) for injectable suspension is a sterile lyophilized powder. RYANODEX is supplied in 20 mL vials containing 250 mg dantrolene sodium and the following inactive ingredients: 125 mg mannitol, 25 mg polysorbate 80, 4 mg povidone K12 and sufficient sodium hydroxide or hydrochloric acid for pH adjustment. When reconstituted with 5 mL sterile water for injection USP (without a bacteriostatic agent), this yields a suspension with a pH of approximately 10.3.
RYANODEX is a skeletal muscle relaxant. Chemically, RYANODEX is a hydrate of 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione sodium salt. The structural formula for the hydrated salt is:
The hydrated salt contains approximately 15% water (3-1/2 moles) and has a molecular weight of 399. The anhydrous salt (dantrolene) has a molecular weight of 336.
Sources
Ryanodex Dantrolene Sodium Manufacturers
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Eagle Pharmaceuticals, Inc.
![Ryanodex Dantrolene Sodium (Dantrolene Sodium) Injection, Suspension [Eagle Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ryanodex Dantrolene Sodium | Eagle Pharmaceuticals, Inc.
2.1 Dosage for Treatment of Malignant HyperthermiaIn addition to RYANODEX treatment, institute the following supportive measures:
Discontinue use of malignant hyperthermia (MH)-triggering anesthetic agents (i.e., volatile anesthetic gases and succinylcholine). Manage the metabolic acidosis Institute cooling when necessary Administer diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX is insufficient to maintain diuresis) [see Description (11)]Administer RYANODEX by intravenous push at a minimum dose of 1 mg/kg. If the physiologic and metabolic abnormalities of MH continue, administer additional intravenous boluses up to the maximum cumulative dosage of 10 mg/kg.
If the physiologic and metabolic abnormalities reappear, repeat RYANODEX dosing by intravenous push starting with 1 mg/kg.
2.2 Dosage for Prevention of Malignant HyperthermiaThe recommended prophylactic dose of RYANODEX is 2.5 mg/kg administered intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery. Avoid agents that trigger MH.
If surgery is prolonged, administer additional individualized RYANODEX doses during anesthesia and surgery [see Clinical Pharmacology (12.3)].
2.3 Dosage for Pediatric PatientsThe recommended weight-based dose of RYANODEX for pediatric patients in the treatment and prevention of MH is the same as for adults for these indications [see Dosage and Administration (2.1, 2.2)].
2.4 Reconstitution and Administration InstructionsThe supplied lyophilized powder must be reconstituted prior to administration:
Reconstitute each vial of RYANODEX lyophilized powder by adding 5 mL of sterile water for injection (without a bacteriostatic agent). Do not reconstitute with any other solution (e.g., 5% dextrose injection, 0.9% sodium chloride injection). Shake the vial to ensure an orange-colored uniform suspension. Visually inspect the vial for particulate matter and discoloration prior to administration. Must use the contents of the vial within 6 hours after reconstitution. Store reconstituted suspensions at controlled room temperature (68°F to 77°F or 20°C to 25°C).Do not dilute or transfer the reconstituted RYANODEX suspension to another container to infuse the product.
Administer the reconstituted RYANODEX suspension either:
Into the intravenous catheter while an intravenous infusion of 0.9% sodium chloride injection, or 5% dextrose injection is freely running; or Into the indwelling catheter - after assuring its patency - without a freely running infusion. Flush the line to assure that there is no residual RYANODEX remaining in the catheter [see Warnings and Precautions (5.3)].
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