Pregabaline

Generic name
Pregabaline
Brand name
ATC Code
N03AX16
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Pregabaline

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information on pharmacokinetic parameters in children available.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

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. 

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

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.

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.

Interactions

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

ANTIEPILEPTICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Barbiturates and derivatives
N03AA02
N03AA03
Hydantoin derivatives
N03AB02
Succinimide derivatives
N03AD01
Benzodiazepine derivatives
N03AE01
Carboxamide derivatives
N03AF01
N03AF02
N03AF03
Fatty acid derivatives
N03AG01
N03AG04
Other antiepileptics
N03AX23
N03AX24
N03AX10
N03AX26
N03AX18
N03AX09
N03AX14
N03AX22
N03AX17
N03AX03
N03AX11
N03AX15

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

Changes

Therapeutic Drug Monitoring


Overdose