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

Interactions
PK
Renal impairment
References

Baclofen

Generic name
Baclofen
Brand name
ATC Code
M03BX01

Pharmacokinetics in children

The following kinetic parameters have been observed in children aged 2-12 years after an oral dose of 2.5 mg:

Cl: 315.9 ml/hour/kg
Vd: 2.58 l/kg
T½: 5.1 hours
Tmax: 0.95-2 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

Muscle spasms
  • Oral
    • 3 months up to 8 years
      • Initial dose: 0.3 mg/kg/day in 4 doses.
      • Maintenance dose: Increase step by step by 0.3 mg/kg/day to 0.75 - 2 mg/kg/day in 4 doses. Max: 40 mg/day.

      • Extramural: increase every 14 days
        Intramural: increase every 3-7 days

    • 8 years up to 18 years
      • Initial dose: 0.3 mg/kg/day in 4 doses.
      • Maintenance dose: Increase step by step by 0.3 mg/kg/day to 0.75 - 2 mg/kg/day in 4 doses. Max: 60 mg/day.

      • Extramural: increase every 14 days
        Intramural: increase every 3-7 days
Spierspasmen van cerebrale of spinale oorsprong
  • Intrathecal
    • ≥ 4 years

      • Initial dose: test dose 25-50 mcg/day intrathecally; depending on the response, increase by 25 mcg every 24 hours to a maximum of 100 mcg.
        Maintenance dose:
        Effect of the test dose < 12 hours: double the effective test dose, administer over 24 hours.    
        Effect of the test dose > 12 hours: effective test dose, over 24 hours.
        After the first 24 hours, slowly adjust the dose daily in steps of max. 5-15% of the daily dose. Max. 1000 mcg/day

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Renal impaiment in children > 3 months

When used orally:

  • GFR ≥ 50 ml/min/1.73 m2: dose adjustment is not necessary.
  • GFR 30-50 ml/min/1.73 m2: 100% of normal reversal dose, interval between 2 doses: 24 hours, then dose according to effect and side effect.
  • GFR 10-30 ml/min/1.73 m2: 100% of normal reversal dose, interval between 2 doses: 24 hours, then dose according to effect and side effect.
  • GFR <10 ml/min/1.73 m2: general advice is not given.

When used intrathecally: dose adjustment is not necessary.

Clinical consequences

With impaired renal function, the renal clearance of baclofen decreases. This increases the risk of adverse reactions.

Clinical Effects:

Characteristic symptoms of overdose include central nervous system depression, respiratory depression, convulsions, myoclonia, muscle weakness, and hypotonia and hyporeflexia.

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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

Sedation (particularly at the start of treatment), vomiting and diarrhoea.

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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

Reduce the dose in muscular hypotonia. Down titrate the dosage when stopping after long-term therapy.

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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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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Novartis Pharma BV, SPC Lioresal (RVG 06347), www.cbg-meb.nl, Geraadpleegd 26 mei 2010, http://db.cbg-meb.nl/IB-teksten/h06347.pdf
  3. Sintetica GmHb, SmPC Baclofen (RVG 120889) 06-09-2018, www.geneesmiddelinformatiebank.nl
  4. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021

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Changes

Changes