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

Interactions
PK
Renal impairment
References

Kaliumcitraat + kaliumwaterstofcarbonaat

Generic name
Kaliumcitraat + kaliumwaterstofcarbonaat
Brand name
ATC Code
A12BA30

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Distal renal tubular acidosis (dRTA)
  • Oral
    • 1 year up to 4 years
      • Start:  4 mEq/kg/day in 2 doses. Max: 10mEq/kg/day, but not exceeding 336 mEq/day.
      • Adjust the dosage based on bicarbonate plasma levels up or down in increments of max. 1.5 mEq/kg/day to an optimal dose.

    • 4 years up to 12 years
      • Start:  2 mEq/kg/day in 2 doses. Max: 10mEq/kg/day, but not exceeding 336 mEq/day.
      • Adjust the dosage based on bicarbonate plasma levels up or down in increments of max. 1.5 mEq/kg/day to an optimal dose.

    • 12 years up to 18 years
      • Start:  1 mEq/kg/day in 2 doses. Max: 10mEq/kg/day, but not exceeding 336 mEq/day.
      • Adjust the dosage based on bicarbonate plasma levels up or down in increments of max. 1 mEq/kg/day to an optimal dose.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

In clinical studies with small numbers of patients, the safety profile for children was similar to that of adult patients [SmPC].

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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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Reference

  1. Advicenne S.A., SmPC Sibnayal (EU/1/20/1517/001) Rev.2 30-6-2023, www.geneesmiddelinformatiebank.nl

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Changes

Changes