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

Interactions
PK
Renal impairment
References

Nifedipine

Generic name
Nifedipine
Brand name
ATC Code
C08CA05

Pharmacokinetics in children

No information

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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

Hypertension
  • Oral
    • 1 month up to 18 years
      • Initial dose: 0.1 mg/kg/dose, once only.
      • Maintenance dose: 0.25 - 0.5 mg/kg/day in 1 - 4 doses. Max: 1mg/kg/day, but not exceeding 60 mg/day.    .

      • Dosing frequency maintenance dose: Controlled-release tablet: in a single dose; slow release in 2-4 doses.
        In exceptional cases – only after consulting a paediatric nephrologist – a dosage up to a maximum of 3 mg/kg/day (max 120 mg /dag) may be necessary.
Raynaud's phenomenon
  • Oral
    • ≥ 2 years

      • No dose recommendations:
        There are only a few case descriptions available about the use of nifedipine with Raynaud's phenomenon in children. Properly substantiated dose recommendations can therefore not be given. A description of the cases therefore follows:

        • Girl aged 29 months, 2.5 mg twice daily. Nifedipine was tolerated well, no other side effects than flushing. (Herrick 1991)
        • 6-year-old girl and 8-year-old boy, 10-13 mg/day (Matucci 1985)
        • 3 girls (10, 13 and 13.5 years), 0.25 mg/kg twice daily, safe and effective, no side effects (Kaya, 1989)

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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

Flushing, dizziness, oedema, gingival recession with chronic 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

Note that there are different preparations. The “slow-release” tablet is not a controlled-release tablet, but is referred to this way because nifedipine dissolves from the tablet slowly. There is no longer any place for a fast-acting preparation (the capsule) in the treatment.
Differences between ‘OROS’ and slow-release, drawn from pharmacotherapeutic compass: in adults:
Tmax: OROS 6 hours; slow-release 1.6-4 hours.


 

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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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Dihydropyridine derivatives
C08CA01
C08CA04

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References

  1. Blaszak RT, et al, The use of short-acting nifedipine in pediatric patients with hypertension, J Pediatr., 2001, Jul;139(1), 34-7
  2. Egger DW, et al, Evaluation of the safety of short-acting nifedipine in children with hypertension, Pediatr Nephrol, 2002, Jan;17(1), 35-40
  3. Herrick AL et al, Primary Raynaud's phenomenon in early childhood, Br J Rheumatol, 1991, Jun; 30 (3), 223-5
  4. Matucci M, Nifedipine treatment of Raynaud's phenomenon in an pediatric age, Int J Clin Pharmacol Res, 1985, 5(1), 67-9
  5. Kaya IS et al, Nifedipine in the treatment of Raynaud's disease in childhood, Lancet, 1989, 20;1(8647), 1136
  6. Lurbe E, et al, Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension, J Hypertens, 2016, Oct;34(10), 1887-920
  7. Flynn JT, et al SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. , Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. , Pediatrics, 2017, Sep 140(3), e20171904
  8. Flynn JT, et al SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN., Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents., Pediatrics, 2017, Sep 140(3), e20171904

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Changes

Changes