Levocarnitine

Generic name
Levocarnitine
Brand name
ATC Code
A16AA01

Levocarnitine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The systemic availability after oral administration is very low (<10%) and highly variable.

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

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Primary carnitine deficiency
  • Intravenous
    • < 1 year
      • To a maximum of 30 mg/kg/day in 1 dose
        • Only administer intravenously when oral administration is not possible.
        • The liquid for injection must be administered gradually intravenously (3 minutes)
    • 1 year up to 12 years
      • To a maximum of 20 mg/kg/day in 1 dose
        • Only administer intravenously when oral administration is not possible.
        • The liquid for injection must be administered gradually intravenously (3 minutes)
    • 12 years up to 18 years
      • To a maximum of 20 mg/kg/day in 1 dose
        • Only administer intravenously when oral administration is not possible.
        • The liquid for injection must be administered gradually intravenously (3 minutes)
  • Oral
    • < 1 year
      • 100 - 150 mg/kg/day in 3 doses.
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine for this indication.

    • 1 year up to 12 years
      • 50 - 100 mg/kg/day in 3 doses.
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine for this indication.

    • 12 years up to 18 years
      • 20 - 40 mg/kg/day in 2 - 3 doses.
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine for this indication.

Acute disturbance: Organic aciduria; carnitine transporter defect; MCAD deficiency; mitochondrial abnormalities
  • Intravenous
    • 0 years up to 18 years
      • Initial dose: (only in organic aciduria) 100 mg/kg/dose, bolus.
      • Maintenance dose: 50 - 200 mg/kg/day, continuous infusion.
      • Alternative dosing frequency: in 4-6 doses.

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

Cystinosis in renal tubular (and glomerular) dysfunction or renal impairment
  • Oral
    • 0 years up to 18 years
      • 50 - 100 mg/kg/day in 1 dose
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine for this indication

Organic aciduria
  • Oral
    • 0 years up to 18 years
      • 100 mg/kg/day in 3 - 4 doses.
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine for this indication

Acyl-CoA dehydrogenase defects
  • Intravenous
    • 0 years up to 18 years
      • 100 - 200 mg/kg/day in 3 - 4 doses.
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine for this indication.

Isolated 3-methylcrotonyl-CoA carboxylase deficiency
  • Oral
    • 0 years up to 18 years
      • 100 mg/kg/day in 3 - 4 doses.
      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using levocarnitine 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 in children

Sodium benzoate for tackling secondary hyperammonaemia is contraindicated in organic acid disorders. Patients with organic acid disorders have a tendency to develop hypokalaemia. Potassium levels must only be corrected if there is diuresis.

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
A16AA06
A16AA05
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
A16AA06
A16AA05
A16AA04

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Sigma-Tau BV, SPC Carnitene (RVG 11193 + 11192 ), www.cbg-meb.nl, Geraadpleegd 13 sept 2012, http://db.cbg-meb.nl/IB-teksten/h11192.pdf
  3. Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases, Springer, 2006
  4. Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases, Springer, 2006

Changes

Therapeutic Drug Monitoring


Overdose