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

Interactions
PK
Renal impairment
References

Paricalcitol

Generic name
Paricalcitol
Brand name
ATC Code
H05BX02

Pharmacokinetics in children

Ages 10-16 Stage 3 CRI Stage 4 CRI
13.3 ± 4.3 hours 15.2 ± 4.4 hours
Cmax 0.12 ± 0.06 ng/ml 0.14 ± 0.05 ng/ml

Source: SmPC

 

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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

Prevention and treatment of secondary hyperparathyroidism in chronic renal disease stage 3-4
  • Oral
    • 10 years up to 17 years
      • Initial dose: 1 microg./dose 3x per week.
      • Maintenance dose: Titrate the starting dose based on the iPTH, serum calcium and serum phosphate levels.  1 - 7 microg./dose 3x per week.
        • Increase in steps of 1 mcg per 4 weeks
        • The dose can be reduced by 1 mcg at any time, or discontinued and resumed later if the patient is already receiving the lowest dose of 1 mcg.
    • ≥ 17 years
      • Initial dose based on the baseline iPTH concentration:
        < 500 pg/ml: 1 mcg/day or 2 mcg 3x per week
        > 500 pg/ml:  2 mcg/day or 4 mcg 3x per week
        Maintenance: titrate based on the iPTH, serum calcium and serum phosphate levels.

        • If the PTH concentration decreases by 30-60%, maintain dosage;
        • if the PTH concentration increases, remains the same or decreases by less than 30%, increase the dose by 1 mcg once a day or 2 mcg 3xd per week, at intervals of 2-4 weeks;
        • if the PTH concentration decreases by more than 60% or if the concentration of intact PTH goes below 60 pg/ml, reduce the dose by 1 µg once a day or 2 µg 3x a week, at intervals of 2-4 weeks; if the patient is already receiving the lowest dose, the dosing frequency can be reduced;

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Renal impaiment in children > 3 months

Not applicable (indicated for children with renal function disorder)

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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

Hypercalcaemia, hyperphosphataemia, headaches and nausea have been reported in children.

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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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Other anti-parathyroid agents
H05BX01

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References

  1. Regiomedica GmbH, SmPC Porontazin (RVG 113731) 26-11-2020 , www.geneesmiddeleninformatiebank.nl
  2. Regiomedica GmbH, SmPC Porontazin (RVG 113731) 26-11-2020, www.geneesmiddeleninformatiebank.nl

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Changes

Changes