Ryanodex

— THERAPEUTIC CATEGORIES —
  • Inborn errors of metabolism
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ryanodex Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dantrolene sodium 250mg; per vial; lyophilized pwd for IV inj after reconstitution.

    Pharmacological Class

    Muscle relaxant (skeletal).

    How Supplied

    Single-use vial (20mL)—1 (w. diluent)

    Storage

    Store unreconstituted product at 20 °C to 25 °C (68 °F to 77 °F) [see USP Controlled Room Temperature], with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) and avoid prolonged exposure to light. 

    Manufacturer

    Eagle Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    In isolated nerve-muscle preparation, dantrolene has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, dantrolene dissociates the excitation-contraction coupling, probably by interfering with the release of Ca++ from the sarcoplasmic reticulum.

    Ryanodex Indications

    Indications

    Treatment of malignant hyperthermia (MH) in conjunction with appropriate supportive measures. Prevention of malignant hyperthermia in high-risk patients.

    Ryanodex Dosage and Administration

    Adults and Children

    Treatment: Give by IV push at a minimum of 1mg/kg; if psychologic and metabolic abnormalities continues or reappear, repeat dosing; max cumulative dose: 10mg/kg. Prevention: Start approx. 75mins prior to surgery. 2.5mg/kg by IV over ≥1min; may give additional doses if surgery prolonged.

    Ryanodex Contraindications

    Not Applicable

    Ryanodex Boxed Warnings

    Not Applicable

    Ryanodex Warnings/Precautions

    Warnings/Precautions

    Institute supportive measures (eg, discontinue MH-triggering agents, manage metabolic acidosis, cooling if necessary, diuretic administration). Monitor for skeletal muscle weakness, adequate ventilation, difficulty swallowing and choking. Avoid extravasation. Elderly. Pregnancy. Nursing mothers: not recommended.

    Ryanodex Pharmacokinetics

    Absorption

    Median time to peak concentration: 1 minute post-dose. Maximum plasma concentration: 9.0 ± 4.6 μg/mL.

    Distribution

    Volume of distribution: 36.4 ± 11.7 L.

    Metabolism

    Hepatic.

    Elimination

    Half-life: 10.8 ± 2.2 hours. Clearance: 2.5 ± 1.0 L/hr.

    Ryanodex Interactions

    Interactions

    Avoid MH-triggering agents. Increased risk of somnolence or dizziness with concomitant sedative agents. Concomitant calcium channel blockers: not recommended. Concomitant other muscle relaxants may potentiate neuromuscular block. Increased CNS effects with concomitant antipsychotics, anxiolytics.

    Ryanodex Adverse Reactions

    Adverse Reactions

    Loss of grip strength, weakness in the legs, drowsiness, flushing, somnolence, dizziness, nausea, thrombophlebitis, tissue necrosis secondary to extravasation, urticaria, inj site reactions (eg, pain, erythema, swelling); dyspnea, dysphasia.

    Ryanodex Clinical Trials

    See Literature

    Ryanodex Note

    Not Applicable

    Ryanodex Patient Counseling

    See Literature

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