pharmacopeia
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Boxed warning

Dantrolene sodium has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to dantrolene sodium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to dantrolene sodium . Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium . However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection).

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Calcium Channel Antagonists.

Calcium Channel

Indications

Sourced from openFDA
  • In Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity.ICD-10: G35, I63.9

Contraindications

Sourced from openFDA
  • Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium . Dantrolene sodium is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function.contraindicated

Dosage & administration

Sourced from openFDA

For Use in Chronic Spasticity: Prior to the administration of dantrolene sodium , consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with dantrolene sodium . Refer to INDICATIONS AND USAGE section for description of response to be anticipated. It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning dantrolene sodium therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated. Usual Dosage: It is important that the dosage be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended. In view of the potential for liver damage in long-term dantrolene sodium use, therapy should be stopped if benefits are not evident within 45 days. Adults: The following gradual titration schedule is suggested. Some patients will not respond until higher daily dosage is achieved. Each dosage level should be maintained for seven days to determine the patient's response. If no further benefit is observed at the next higher dose, dosage should be decreased to the previous lower dose. 25 mg once daily for seven days, then 25 mg t.i.d. for seven days 50 mg t.i.d. for seven days 100 mg t.i.d.

Warnings & precautions

Sourced from openFDA

It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy. At the start of dantrolene sodium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease. If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for dantrolene sodium hepatotoxicity could be enhanced, although such a possibility has not yet been established. Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during dantrolene sodium therapy. If such studies reveal abnormal values, therapy should generally be discontinued. Only where benefits of the drug have been of major importance to the patient, should reinitiation or continuation of therapy be considered. Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, dantrolene sodium should be discontinued. If caused by dantrolene sodium and detected early, the abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Dantrolene sodium therapy has been reinstituted in a few patients who have developed clinical and/or laboratory evidence of hepatocellular injury.

Adverse reactions

Sourced from openFDA

The most frequently occurring side effects of dantrolene sodium have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of dantrolene sodium therapy. If diarrhea recurs upon readministration of dantrolene sodium , therapy should probably be withdrawn permanently. Other less frequent side effects, listed according to system, are: Gastrointestinal: Constipation, rarely progressing to signs of intestinal obstruction, GI bleeding, anorexia, swallowing difficulty, gastric irritation, abdominal cramps, nausea and/or vomiting. Hepatobiliary: Hepatitis (see WARNINGS ). Neurologic: Speech disturbance, seizure, headache, light-headedness, visual disturbance, diplopia, alteration of taste, insomnia, drooling. Cardiovascular: Tachycardia, erratic blood pressure, phlebitis, heart failure. Hematologic: Aplastic anemia, anemia, leukopenia, lymphocytic lymphoma, thrombocytopenia. Psychiatric: Mental depression, mental confusion, increased nervousness. Urogenital: Increased urinary frequency, crystalluria, hematuria, difficult erection, urinary incontinence and/or nocturia, difficult urination and/or urinary retention. Integumentary: Abnormal hair growth, acne-like rash, pruritus, urticaria, eczematoid eruption, sweating. Musculoskeletal: Myalgia, backache.

Use in specific populations

Sourced from openFDA

Pregnancy: Adequate animal reproduction studies have not been conducted with dantrolene sodium . It is also not known whether dantrolene sodium can cause fatal harm when administered to a pregnant woman or can affect reproduction capacity. Dantrolene sodium should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea, and crystalluria. For acute overdose, general supportive measures should be employed along with immediate gastric lavage. Intravenous fluids should be administered in fairly large quantities to avert the possibility of crystalluria. An adequate airway should be maintained and artificial resuscitation equipment should be at hand. Electrocardiographic monitoring should be instituted, and the patient carefully observed. To date, no experience has been reported with dialysis and its value in dantrolene sodium overdose is not known.

Approval history

Sourced from openFDA
  • Jan 15, 1974NDANDA017443Ph Health
  • Sep 19, 1979NDANDA018264Ph Health
  • Mar 1, 2005ANDAANDA076856Impax Labs
  • Oct 24, 2005ANDAANDA076686Elite Labs Inc
  • Jul 24, 2007ANDAANDA078378Uswm
  • Jul 22, 2014NDANDA205579Eagle Pharms
  • Jun 19, 2017ANDAANDA204762Hikma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,738 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Neuroleptic Malignant Syndrome1719.8%
  2. 2Drug Ineffective1558.9%
  3. 3Off Label Use1156.6%
  4. 4Pyrexia925.3%
  5. 5Asthenia774.4%
  6. 6Pneumonia764.4%
  7. 7Respiratory Failure754.3%
  8. 8Urinary Tract Infection724.1%
  9. 9Vomiting683.9%
  10. 10Fatigue613.5%
  11. 11Nausea593.4%
  12. 12Diarrhoea573.3%
  13. 13Fall573.3%
  14. 14Hypertension563.2%
  15. 15Muscular Weakness553.2%

Literature

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Recent PubMed references pinned to Dantrolene as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 12 ClinicalTrials.gov registrations naming Dantrolene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dantrolene work?
Mechanism-of-action class: Calcium Channel Antagonists.
What is Dantrolene used for?
According to FDA labeling, Dantrolene carries indications including: In Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dantrolene?
Dantrolene is classified as Dantrolene and derivatives, Skeletal Muscle Relaxant, Calcium Channel Antagonists, Decreased Striated Muscle Contraction, Decreased Striated Muscle Tone, Striated Muscle Metabolic Alteration.
What are the brand names for Dantrolene?
Dantrolene is marketed under brand names including Dantrium, Revonto, Ryanodex.
What are the contraindications for Dantrolene?
Dantrolene labeling lists contraindications including: Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium . Dantrolene sodium is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function.. Always consult the full prescribing information and a clinician.
Note. Data for dantrolene is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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