These highlights do not include all the information needed to use RYANODEX safely and effectively. See full prescribing information for RYANODEX.
RYANODEX ® (dantrolene sodium) for injectable suspension, for intravenous use.
Initial U.S. Approval: 1974
INDICATIONS AND USAGE
RYANODEX is a skeletal muscle relaxant drug indicated for:
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Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. (1)
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Prevention of malignant hyperthermia in patients at high risk. (1
DOSAGE AND ADMINISTRATION
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Treatment of Malignant Hyperthermia (MH) (2.1)
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Administer by intravenous push at a minimum of 1 mg/kg. If signs continue, administer additional intravenous boluses up to maximum cumulative dosage of 10 mg/kg.
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Institute supportive measures (e.g., discontinue MH-triggering agents, manage metabolic acidosis, cooling if necessary, administer diuretics)
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Prevention of MH in Patients at High Risk (2.2)
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Administer 2.5 mg/kg intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery.
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Avoid agents that trigger MH.
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Administer additional individualized doses during anesthesia and surgery if surgery is prolonged.
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Pediatric Patients: recommended weight-based dose is the same as for adults (2.3)
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Reconstitution: With 5 mL of sterile water for injection (without a bacteriostatic agent) prior to administration (2.4)
DOSAGE FORMS AND STRENGTHS
For injectable suspension: 250 mg of lyophilized powder in a single-use vial for reconstitution (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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Skeletal muscle weakness: Ambulate patients with assistance until they have normal strength and balan
