Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Dantrolene

Generic name
Dantrolene
Brand name
ATC Code
M03CA01

Pharmacokinetics in children

After intravenous administration:

Children aged 2-7 years (Lerman et al 1989):
- T½ = 10.0 ± 2.6 hours
- Clearance = 0.64±0.175 ml/min/kg

Neonates (Shime et al 1988):
- T½ = approx. 20 hours

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Malignant hyperthermia
  • Intravenous
    • 1 month up to 18 years
      • 2.5 mg/kg/dose, bolus. Repeat until the symptoms have cleared..

      • Usually a cumulative dose of up to 10 mg/kg/day is sufficient, but higher cumulative doses have been described.

    • Term neonate
      • 2.5 mg/kg/dose, bolus. Repeat until the symptoms have cleared..

      • Usually a cumulative dose of up to 10 mg/kg/day is sufficient, but higher cumulative doses have been described.
Muscle spasms
  • Oral
    • 18 months up to 18 years and < 25 kg
      • Initial dose: 0.5 mg/kg/day in 1 dose
      • Maintenance dose: If needed, increase weekly with dose increments of 0,5-1 mg/kg/dag to 0.5 - 8 mg/kg/day in 3 - 4 doses. Max: 12mg/kg/day, but not exceeding 200 mg/day.
    • 25 up to 50 kg

      • Week 1: 25 mg/day in 1 dose 
        Week 2: 50 mg/day in 2 doses
        Week 3: 75 mg/day in 3 doses
        Week 4: 100 mg/day in 2 doses
        Week 5: 150 mg/day in 3 doses
        Week 6: 225 mg/day in 3 doses
        Max: 200 mg/day

        • Titrate until the desired individual effect is achieved; aiming for the lowest effective dose.
        • If therapeutic efficacy is still not achieved after 6-8 weeks of treatment, therapy should be discontinued.  
    • ≥ 50 kg

      • Week 1: 25 mg/day in 1 dose 
        Week 2: 50 mg/day in 2 doses
        Week 3: 100 mg/day in 2 doses
        Week 4: 150 mg/day in 3 doses
        Max. 200 mg/day

        In crowded or stressful situations, temporarily increase gradually to:
        Week 5: 225 mg/day in 3 doses
        Week 6: 300 mg/day in 4 doses
        Week 7: 400 mg/day in 4 doses

        • Titrate incrementally until the desired individual effect is achieved; aiming for the lowest effective dose.
        • If therapeutic efficacy is still not achieved after 6-8 weeks of treatment, therapy should be discontinued.  

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

After intravenous administration:
Dizziness, sleepiness and nausea. 
Rare: pulmonary oedema. Very rare: urticaria, erythema.
 
After oral administration:
Drowsiness, tiredness, weakness. Less frequent: diarrhea. Liver toxicity has been described after long-term use.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Cave extravasation of the infusion liquid as the solution is strongly alkaline. Check the hepatic function.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Dantrolene and derivatives
M03CA01

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References

  1. Lerman J, et al, Pharmacokinetics of intravenous dantrolene in children, Anesthesiology, 1989, Apr;70(4), 625-9
  2. Shime J, et al, Dantrolene in pregnancy: lack of adverse effects on the fetus and newborn infant., Am J Obstet Gynecol, 1988, Oct;159(4), 831-4
  3. Flewellen EH, et al, Prophylactic and therapeutic doses of dantrolene for malignant hyperthermia, Anesthesiology, 1984, Oct;61(4), 477
  4. Playfor SD, Malignant hyperthermia, Lancet., 1998, Nov 28;352(9142), 1785-6
  5. Blank JW, et al, Successful treatment of an episode of malignant hyperthermia using a large dose of dantrolene, J Clin Anesth, 1993, Jan-Feb;5(1), 69-72
  6. (MHAUS) MHAotUS, Malignant Hyperthermia Association of the United States: Emergency Therapy for Malignant Hyperthermia, Sherburne2008, [cited 2011 05/30/2011], Available from: http://medical.mhaus.org/PubData/PDFs/treatmentposter.pdf.
  7. Ali SZ, et al, Malignant hyperthermia, Best Pract Res Clin Anaesthesiol, 2003, Dec;17(4), 519-33
  8. Glahn KP, et al, Recognizing and managing a malignant hyperthermia crisis: guidelines from the European Malignant Hyperthermia Group, Br J Anaesth, 2010, Oct;105(4), 417-20
  9. Harrison GG, Malignant hyperthermia. Dantrolene--dynamics and kinetics, Br J Anaesth, 1988, Feb;60(3), 279-86
  10. Norgine BV, SmPC Dantrium (RVG 06978) 17-12-2021, www.geneesmiddeleninformatiebank.nl
  11. Joynt, R. L., et al, Dantrolene sodium suspension in treatment of spastic cerebral palsy., Developmental medicine and child neurology,, 1980, 22(6), 755–767
  12. Haslam, R. H., et al., Dantrolene sodium in children with spasticity, Archives of physical medicine and rehabilitation, 1974, 55(8), 384–388
  13. Cummings, T., et al, Repeated nonanesthetic malignant hyperthermia reactions in a child., Paediatric anaesthesia, 2016, 26(12), 1202–1203
  14. Tsutsumi, Y. M., et al, Malignant hyperthermia in a 16-day-old infant with congenital diaphragmatic hernia: a case report., Journal of anesthesia, 2021, 35(2), 311–314
  15. Aguilar Bernal, et al., Efficacy of dantrolene sodium in management of tetanus in children. , Journal of the Royal Society of Medicine, 1986, 79(5), 277–281
  16. Norgine BV, SmPC Dantrium IV (RVG 08616) 29-01-2022, www.geneesmiddeleninformatiebank.nl
  17. Denhoff, E.et al, Treatment of spastic cerebral-palsied children with sodium dantrolene. , Developmental medicine and child neurology,, 1975, 17(6), 736–742
  18. Norgine BV, SmPC Dantrium (RVG 06978) 17-12-2021, www.geneesmiddeleninformatiebank.nl
  19. Aguilar Bernal, et al., Efficacy of dantrolene sodium in management of tetanus in children., Journal of the Royal Society of Medicine, 1986, 79(5), 277–281
  20. Denhoff, E.et al, Treatment of spastic cerebral-palsied children with sodium dantrolene., Developmental medicine and child neurology,, 1975, 17(6), 736–742

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Changes

Changes