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

Interactions
PK
Renal impairment
References

Pregabaline

Generic name
Pregabaline
Brand name
ATC Code
N03AX16

Pharmacokinetics in children

No information on pharmacokinetic parameters in children available.

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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

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Dosages

Neuropathic pain
  • Oral
    • 1 year up to 12 years
      • Initial dose: 2.5 mg/kg/day in 1 - 2 doses.
      • Maintenance dose: Increase dose if indicated every 2-3 days up to max 15 mg/kg/day in 2 - 3 doses. Max: 600 mg/day.
      • When discontinuing treatment, decrease the dose comparable to dose increase at start of treatment. 

    • 12 years up to 18 years
      • Initial dose: 75 mg/day in 1 dose
      • Maintenance dose: Increase dose if indicated every 2-3 days with 75 mg/dose increments to 10 mg/kg/day in 2 - 3 doses. Max: 600 mg/day.
      • When discontinuing treatment, decrease the dose comparable to dose increase at start of treatment. 

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
No dose adjustment needed
GFR 30-50 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 8 up to 12 uur
GFR 10-30 ml/min/1.73 m2
25 percentage of single dose and dosing interval : 8 up to 12 uur
GFR < 10 ml/min/1.73 m2
A general recommendation is not 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

No information is present at this moment.

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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

No information available on specific warnings and precautions in children.

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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. Saltik S, et al, Pregabalin treatment of patient with complex regional pain syndrome, Pediatr Neurol, 2016, Jan;54, 88-90
  2. Pedemonte Stalla V, et al, Complex regional pain syndrome type i. An analysis of 7 cases in children, Neurologia, 2015, Jul-Aug;30(6), 347-51
  3. Arnold LM, et al, Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study, Pediatr Rheumatol Online J, 2016, Jul 30;14(1), 46
  4. Vondracek P, et al, Efficacy of pregabalin in neuropathic pain in paediatric oncological patients,, Eur J Paediatr Neurol, 2009, Jul;13(4, 332-6

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Changes

Changes