Dantrium (dantrolene), produced by Par Sterile Products, is a U.S. Food and Drug Administration (FDA) approved therapy for chronic spasticity (muscle spasms) from upper motor neuron disorders caused by MS and other conditions. The therapy induces skeletal muscle relaxation by affecting the contractile response.

Dantrium (dantrolene) is to be taken by mouth in weekly specified doses until benefit is observed.  Patients begin with 25 mg daily for seven days. They then take 25 mg three times a day for seven days, then 50 mg three times a day for seven days, followed by 100 mg three times a day (until a maximum dosage of 100 mg four times a day). In the event that no further benefit is observed at the next higher dose, dosage should be decreased to the previous dose.

The most common adverse effects reported were: muscle weakness, drowsiness, dizziness, fatigue, confusion, nervousness, nausea, thrombophlebitis, urticarial, erythema, and injection site reactions.

The therapy also includes a black box warning on the prescription drug label to call attention to serious or life-threatening risks. Dantrium may cause serious liver toxicity and symptomatic hepatitis (fatal or nonfatal) with different dosages. The risk of hepatic (liver) injury appears to be greater in women over age 35 who take higher dosages and other medications. Hepatic function should be monitored during therapy.

Dantrium is also available as a generic medicine.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.


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FDA Approves Botox to Treat Upper Limb Spasticity in Children Aged 2 to 17

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#ACTRIMS2019 – Botox Earns High Marks from Patients, Physicians as Treatment for Spasticity, ASPIRE Follow-up Finds

Patients with a range of diseases and disorders, including multiple sclerosis (MS), report high satisfaction with botulinum toxin — also known as Botox  — as a treatment for spasticity, results from the ASPIRE clinical trial show.

The data were presented last week by Daniel S. Bandari, MD, from the MS Center of California & Research Group at the Hoag Neurosciences Institute, at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in Dallas, Texas. His poster was titled “Individualized OnabotulinumtoxinA Treatment for Spasticity in Multiple Sclerosis Resulted in High Patient and Clinician Satisfaction: The Aspire Study.”

Botox is approved by the U.S. Food and Drug Administration (FDA) to treat muscle spasms, spasticity, and bladder symptoms in patients with a spectrum of diseases, including MS. It is estimated that six to nine of every 10 MS patients experience spasticity at some point.

In collaboration with developer Allergan, an international team of researchers examined real-world data on the effectiveness of Botox to treat spasticity in a study called ASPIRE (NCT01930786). Researchers also assessed both patient and clinician satisfaction with the treatment.

The ASPIRE trial is a prospective, international, multicenter, observational study in centers across North America, Europe, and Asia, that examined 730 adult patients (average age 53.6 years) with spasticity symptoms. In this patient group, the most common diseases were stroke (56%), followed by MS (16%).

Of the initial patients, 397 (54%) completed a two-year follow-up period.

Researchers observed a wide range of injections in upper and lower limbs. Anatomical location and electromyogram (EMG) localization were the most frequently used injection guiding methods in upper and lower limbs, respectively.

In MS patients, the most common treated upper limb spasticity presentation was flexed elbow; the most common lower limb presentation treated was equinovarus foot (in which one or both feet are rotated inward and downward).

Overall, clinicians and patients were satisfied with the effectiveness of Botox in easing spasticity symptoms.

“The majority of patients and clinicians were satisfied that onabotulinumtoxinA treatment improved the patient’s ability to participate in therapy/exercise” Bandari said, specifying 72% of the patients and 91% of the clinicians.

Furthermore, Bandari added, “the majority of patients and clinicians also indicated that they would continue to use onabotulinumtoxinA treatment for spasticity” after the study’s end, specifically 92% of the patients and 98% of clinicians.

Regarding safety, 261 of the initial 730 patients (35.8%), reported 831 adverse side effects. Of these, 23 were considered treatment-related. The most common treatment-related side effect was muscular weakness.

Overall, the team concluded that the results “add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for the treatment of spasticity.”

Bandari also emphasized that “ASPIRE provides valuable, real-world data … which may help guide clinical strategies.” It also “captured the individualized nature of onabotulinumtoxinA utilization for spasticity in MS patients, while consistently demonstrating high satisfaction among patients and clinicians.”

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