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

Interactions
PK
Renal impairment
References

Levamisol

Generic name
Levamisol
Brand name
ATC Code
P02CE01

Pharmacokinetics in children

The following median (IQR) steady state population pharmacokinetic parameters were found in 38 children, 2-13 years of age (median 21 kg and 6,3 years), after oral doses of 2.5 mg/kg every other day (Kreeftmeijer-Vegter et al. 2015):

Cmax 438.3 (316,5 – 621.8) ng/ml
Tmax 1.7 (1.3 – 2.0) hour
2.6 (2.1 – 3.7) hour
Cl/F 44 (RSE 8.5) l/hour/70 kg
Vd/F 236 (RSE 13.3) l/70 kg

IQR = interquartile range

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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

Steroid-sensitive nephrotic syndrome
  • Oral
    • ≥ 1 year
      [2]
      • 2.5 mg/kg/dose every other day. Max: 150 mg/dose.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Leucopenia and gastrointestinal upsets are described. Rare cases of cutaneous vasculitis have been described with levamisole therapy.(KDIGO guideline)

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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

Levamisole has been associated with agranulocytosis. Agranulocytosis is usually accompanied by flu-like symptoms (fever, shivering), but it can also be asymptomatic.Flulike symptoms can also occur without aranulocytosis.Patients and parents should contact their physician whenever flu-like symptoms occur,  It's recommended to check the blood count every 4 weeks. (old SmPC Ergamisol)

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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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Benzimidazole derivatives
P02CA03
P02CA01
Tetrahydropyrimidine derivatives
P02CC01
Avermectines
P02CF01

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References

  1. Kreeftmeijer-Vegter AR, et al , Population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome. , Br J Clin Pharmacol. , 2015, 80(2), 242-252
  2. KDIGO , Clinical Practice Guideline for Glomerulonephritis, Kidney Int, 2012, Vol 2(Suppl 2), 139-274
  3. Jansen Cilag BV, SmPC Ergamisol (RVG 14850) 12 juni 2002 - license revoked by manufacturer
  4. Elmas, A. T., et al, Short- and long-term efficacy of levamisole in children with steroid-sensitive nephrotic syndrome, Int Urol Nephrol, 2013, 45 (4), 1047-55
  5. Gruppen, M. P., et al, A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome, Kidney Int, 2018, 93 (2), 510-518
  6. Pravitsitthikul, N., et al, Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children., Cochrane Database Syst Rev, 2013, (10), Cd002290
  7. IBM Corporation. , 2020 Levamisole. In: In depth answers , Available from: www.micromedexsolutions.com Subscription required to view., [database in the internet]. Greenwood village (CO):

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Changes

Changes