Retinol (vitamin A)

Generic name
Retinol (vitamin A)
Brand name
ATC Code
A11CA01
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Retinol (vitamin A)

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

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Vitamin A deficiency
  • Oral
    • 1 month up to 1 year
      • 4.000 - 6.000 IU/day in 1 dose
    • 11 years up to 18 years
      • 20.000 - 80.000 IU/day in 1 dose
    • 4 years up to 7 years
      • 10.000 - 24.000 IU/day in 1 dose
    • 7 years up to 11 years
      • 16.000 - 50.000 IU/day in 1 dose
Supplementation in cystic fibrosis
  • Oral
    • 1 year up to 4 years
      • 5.000 IU/day in 1 dose

      • Monitoring the serum retinol is recommended. In cases of liver disease, the serum retinol binding protein and retinol ester levels must also be measured annually.

    • 0 years up to 1 year
      • 1.500 IU/day in 1 dose

      • Monitoring the serum retinol is recommended. In cases of liver disease, the serum retinol binding protein and retinol ester levels must also be measured annually.

    • 1 year up to 4 years
      [6] [7]
      • 5.000 IU/day in 1 dose

      • Monitoring the serum retinol is recommended. In cases of liver disease, the serum retinol binding protein and retinol ester levels must also be measured annually.

    • 4 years up to 8 years
      • 5.000 - 10.000 IU/day in 1 dose

      • Monitoring the serum retinol is recommended. In cases of liver disease, the serum retinol binding protein and retinol ester levels must also be measured annually.

    • 8 years up to 18 years
      • 10.000 IU/day in 1 dose

      • Monitoring the serum retinol is recommended. In cases of liver disease, the serum retinol binding protein and retinol ester levels must also be measured annually.
Maintenance requirement
  • Oral
    • < 6 months
      • 1.500 IU/day in 1 dose

      • Use a supplement if insufficient absorption has been demonstrated

        No studies have been carried out into the use of retinol to meet maintenance requirements in children.

        ...read more
    • 6 months up to 10 years
      • 2.300 IU/day in 1 dose

      • Use a supplement if insufficient absorption has been demonstrated.

        No studies have been carried out into the use of retinol to meet maintenance requirements in children.

        ...read more
    • 10 years up to 18 years
      • 3.300 IU/day in 1 dose

      • Use a supplement if insufficient absorption has been demonstrated.

        No studies have been carried out into the use of retinol to meet maintenance requirements in children.

        ...read more
Measles, xerophthalmia, reduction of mortality and morbidity
  • Oral
    • 6 months up to 1 year
      • 100.000 IU/dose every 4-6 months.
    • 1 year up to 18 years
      • 200.000 IU/dose every 4-6 months.

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.

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

Symptoms of acute intoxication have been observed in infants and young children after 75,000 IU: increased intracranial pressure, vomiting, hallucinations and dizziness.

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

In cystic fibrosis and bile duct atresia, measure the plasma concentration once every 6 months. In cystic fibrosis, in liver disease also measure serum 'retinol binding protein' and retinol esters annually in children [Maqbool].

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO

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

Vitamin D and analogues
A11CC03
A11CC04
A11CC05

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Kneepkens CMF et al, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2002, 2e druk
  3. Imdad A, et al, Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age, Cochrane Database Syst Rev, 2010, (12):, CD008524
  4. Benn CS, et al, Randomised study of effect of different doses of vitamin A on childhood morbidity and mortality, BMJ, 2005, Dec 17;331(7530):, 1428-32
  5. Ross DA. , Recommendations for vitamin A supplementation. , J Nutr. , 2002, Sep;132(9 Suppl), 2902S-6S
  6. Sathe MN, et al, Update in pediatrics: focus on fat-soluble vitamins. , Nutr Clin Pract. , 2010, Aug;25(4), 340-6
  7. Maqbool A, et al, Update on fat-soluble vitamins in cystic fibrosis. , Curr Opin Pulm Med., 2008, Nov;14(6), 574-81
  8. Aristo Pharma GmbH, SmPC Vitadral® Tropfen (3000071.00.00), 05/2016
  9. Maqbool A, et al, Update on fat-soluble vitamins in cystic fibrosis., Curr Opin Pulm Med., 2008, Nov;14(6), 574-81
  10. Sathe MN, et al, Update in pediatrics: focus on fat-soluble vitamins., Nutr Clin Pract., 2010, Aug;25(4), 340-6
  11. Ross DA., Recommendations for vitamin A supplementation., J Nutr., 2002, Sep;132(9 Suppl), 2902S-6S

Changes

Therapeutic Drug Monitoring


Overdose