dantrolene sodium

dantrolene sodium

Dantrium, Dantrium Intravenous

FDA Box Warning

Drug may be hepatotoxic and should be used only for recommended conditions. Daily doses of 400 mg are less likely to cause fatal and nonfatal hepatitis than daily doses above 800 mg. Overt hepatitis is most common during months 3 and 12, but may occur at any time; females, patients older than age 35, and those receiving concurrent therapy are at higher risk. Use only in conjunction with liver monitoring. Monitor liver function at baseline and regularly during therapy. Discontinue drug if values are abnormal.

Use lowest possible effective dose. If no benefit occurs after 45 days, discontinue.

Action

Relaxes skeletal muscle by affecting excitation-contraction coupling response at site beyond myoneural junction, probably by interfering with calcium release from sarcoplasmic reticulum

Availability

Capsules: 25 mg, 50 mg, 100 mg

Powder for injection: 20 mg/vial

Indications and dosages

Chronic spasticity resulting from upper motor neuron disorders, such as multiple sclerosis, cerebral palsy, or spinal cord injury

Adults: Initially, 25 mg P.O. daily, increased gradually in 25-mg increments, if needed, up to 100 mg two or three times daily, to a maximum dosage of 400 mg P.O. daily. Maintain dosage level for 4 to 7 days to gauge patient response.

Children: Initially, 0.5 mg/kg P.O. daily for 7 days, increased to 0.5 mg/kg P.O. t.i.d. for 7 days; then 1 mg/kg P.O. t.i.d. for 7 days; then 2 mg/kg t.i.d., as needed. Don't exceed 100 mg P.O. q.i.d.

Malignant hyperthermic crisis

Adults and children: Initially, 1 mg/kg by I.V. push, repeated as needed up to a cumulative dosage of 10 mg/kg/day

To prevent or minimize malignant hyperthermia in patients who require surgery

Adults and children: 4 to 8 mg/kg P.O. daily in three or four divided doses for 1 to 2 days before surgery; give last dose 3 to 4 hours before surgery. Or 2.5 mg/kg I.V. infused over 1 hour before anesthestics are given.

To prevent recurrence of malignant hyperthermic crisis

Adults: 4 to 8 mg/kg daily P.O. in four divided doses for up to 3 days after initial hyperthermic crisis

Off-label uses

• Heat stroke

• Neuroleptic malignant syndrome

Contraindications

• Active hepatic disease (oral form)

• Patients who use spasticity to maintain posture or balance (oral form)

• Breastfeeding

Precautions

Use cautiously in:

• cardiac, hepatic, or respiratory dysfunction or impairment

• women (especially pregnant women)

• adults older than age 35

• children younger than age 5.

Administration

• For I.V. use, add 60 ml of sterile water for injection to each vial; shake until solution is clear. Protect from direct light and use within 6 hours.

• Give therapeutic or emergency dose by rapid I.V. push. Administer followup dose over 2 to 3 minutes.

• Prevent extravasation when giving I.V. Drug has high pH and causes tissue irritation.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, malaise, weakness, confusion, depression, insomnia, nervousness, headache, light-headedness, speech disturbances, seizures

CV: tachycardia, blood pressure fluctuations, phlebitis, heart failure

EENT: double vision, excessive tearing

GI: nausea, vomiting, diarrhea, constipation, abdominal cramps, GI reflux and irritation, hematemesis, difficulty swallowing, anorexia, GI bleeding

GU: urinary frequency, dysuria, nocturia, urinary incontinence, hematuria, crystalluria, prostatitis

Hematologic: aplastic anemia, leukopenia, thrombocytopenia, lymphocytic lymphoma

Hepatic: hepatitis

Musculoskeletal: myalgia, backache

Respiratory: suffocating sensation, respiratory depression, pleural effusion with pericarditis

Skin: rash, urticaria, pruritus, eczemalike eruptions, sweating, photosensitivity, abnormal hair growth

Other: altered taste, chills, fever, edema

Interactions

Drug-drug. CNS depressants: increased CNS depression

Estrogen: increased risk of hepatotoxicity

Verapamil (I.V.): cardiovascular collapse (when given with I.V. dantrolene)

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen: increased values

Drug-behaviors. Alcohol use: increased CNS depression

Sun exposure: phototoxicity

Patient monitoring

• Obtain baseline liver function test results; monitor periodically during therapy.

• Monitor ECG, serum electrolytes, and urine output regularly.

With long-term oral therapy, monitor patient for signs and symptoms of hepatotoxicity. Be prepared to discontinue drug if these occur.

• Assess for muscle weakness, poor coordination, and reduced reflexes before and during therapy. Drug may weaken muscles and impair ambulation.

Patient teaching

Instruct patient receiving prolonged oral therapy to immediately report weakness, malaise, fatigue, nausea, rash, itching, severe diarrhea, bloody or black tarry stools, or yellowing of skin or eyes.

• Inform patient that drug may cause drowsiness, dizziness, or light-headedness.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

dantrolene sodium

(dăn′trō-lēn)
A muscle relaxant used to relieve spasticity.
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References in periodicals archive ?
Tenders are invited for tender for the supply of dantrolene sodium 20mg injections
(NASDAQ: EGRX) has received positive results of its study to evaluate the neuroprotective effects of Ryanodex (dantrolene sodium) secondary to nerve agent exposure, conducted with the United States Army Medical Research Institute of Chemical Defense (USAMRICD), the nation's leading science and technology laboratory in the area of medical chemical countermeasures research and development, the company said.
Eagle Pharmaceuticals announced positive results of its study to evaluate the neuroprotective effects of RYANODEX, or dantrolene sodium, secondary to nerve agent exposure, conducted with the U.S.
A phase 1 clinical trial is currently investigating safety of long term use (A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients with Wolfram Syndrome, ClinicalTrials.gov, NCT02829268).
Ineffectiveness of dantrolene sodium in the treatment of heatstroke.
United States-based Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium), it was reported yesterday.
Dantrolene sodium (DAN) was chosen as an analyte for the following study focused on comparison of electrochemical properties of p-AgSAE, m-AgSAE, and BiFE.
Eagle Pharmaceutical's Ryanodex (dantrolene sodium, injectable suspension) was designated August 16, 2013 as an orphan drug for treatment of malignant hyperthermia, based on a plausible hypothesis of greater safety than the same drug, Par's dantrolene sodium (Dantrium).
Control of the malignant hyperpyrexic syndrome in MHS swine by dantrolene sodium. Br J Anaesth.
Before investigators discovered that dantrolene sodium is an effective treatment for MH, >70% of patients who developed the disease died.
* Others While baclofen and Zanaflex are the most widely used meds, Dantrium (dantrolene sodium), Valium (diazepam), Klonopin (clonazepam) and Neurontin (gabapentin) maybe also be prescribed to control symptoms or pain.
(2001), In vitro antioxidant properties of dantrolene sodium, Pharmacol.