Betaine

Generic name
Betaine
Brand name
ATC Code
A16AA06
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

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

Homocysteine metabolism disorders
  • Oral
    • 0 years up to 10 years
      [2]
      • 100 mg/kg/day in 2 doses. Max: 150 mg/kg/day.

      • Increasing the frequency to more than two daily doses and/or the dose to more than 150 mg/kg/day does not improve the homocysteine-lowering effect.

        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using betaine for this indication.

    • 0 years up to 18 years
      • 100 - 200 mg/kg/day in 2 doses. Titrate dosage individually based on homocysteine and methionine plasma levels..

      • In children < 10 years of age, the homocysteine-lowering effect is not improved by increasing the frequency to more than 2 daily doses and/or the dose to more than 150 mg/kg/day.

        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using betaine for this indication.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

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

Amino acids and derivatives
A16AA05
A16AA01
A16AA04
Enzymes
A16AB03
A16AB04
A16AB07
A16AB13
A16AB22
A16AB17
A16AB08
A16AB09
A16AB02
A16AB05
A16AB14
A16AB10
Various alimentary tract and metabolism products
A16AX10
A16AX09
A16AX
A16AX18
A16AX06
A16AX04
A16AX07
A16AX
A16AX08
A16AX07
A16AX05
AMINO ACIDS AND DERIVATIVES
A16AA05
A16AA01
A16AA04

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Orphan Europe SARL, SPC Cystadane ( EU/1/06/379/001), www.ema.europa.eu, Geraadpleegd 26 mei 2010, http://www.ema.europa.eu/humandocs/PDFs/EPAR/cystadane/ema-combined-h678nl.pdf
  3. Recordati Rare Diseases, SmPC Cystadane ( EU/1/06/379/001) Rev 15; 12-12-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose