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What are the approved indications for dantrolene?

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Dantrolene Indications (FDA-Approved)

Dantrolene is indicated for malignant hyperthermia (MH) and for control of chronic severe spasticity due to upper motor neuron disorders. [1], [2], [3]

Malignant Hyperthermia Treatment

Dantrolene is indicated for treatment of MH in conjunction with appropriate supportive measures. [1], [2]

Malignant Hyperthermia Prevention/Attenuation

Dantrolene is indicated for prevention of MH in patients at high risk. [1], [2]

Oral dantrolene is also indicated preoperatively to prevent or attenuate development of MH signs in known or strongly suspect MH-susceptible patients requiring anesthesia and/or surgery. [3]

Oral dantrolene is indicated following an MH crisis to prevent recurrence of MH signs. [3]

Chronic Severe Spasticity

Dantrolene sodium is indicated in controlling manifestations of clinical spasticity resulting from upper motor neuron disorders (including spinal cord injury, stroke, cerebral palsy, and multiple sclerosis). [3]

Important Label Clarifications

Dantrolene sodium capsules are not indicated for the treatment of skeletal muscle spasm resulting from rheumatic disorders. [3]

Dantrolene sodium capsules are not indicated for the treatment of neuroleptic malignant syndrome (NMS). [3]

Product-Specific Indication Wording

Intravenous dantrolene formulations (e.g., Dantrium Intravenous, Ryanodex) list indications for MH treatment with supportive measures and for MH prevention in high-risk patients. [1], [2]

Oral dantrolene sodium capsules list indications for chronic spasticity and for MH prevention/attenuation in MH-susceptible patients, including perioperative prophylaxis and post-crisis prevention of recurrence. [3]

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