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

Interactions
PK
Renal impairment
References

Betamethasone-17-valerate

Generic name
Betamethasone-17-valerate
Brand name
ATC Code
D07AC01

Pharmacokinetics in children

No information

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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

Atopic dermatitis
  • Cutaneous
    • 1 year up to 18 years
      [1] [2] [6]

      • 0,05%-0,1%: Apply thinly to the affected skin once daily.
        Max: 2-18 yrs: 50 g/week;
        Adults: 100 g/week

      • At the start of the treatment, applying twice daily for a short period of time can be considered.
        If there is improvement, reduce to once daily on 2-4 days/week.
Phimosis
  • Cutaneous
    • 2 years up to 14 years
      [4] [7]

      • 0,05%: apply thinly twice daily

      • Duration of treatment:

        4 weeks. Treat for a further 4 weeks if necessary.

      • Treatment in combination with retraction of the skin.

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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

Children are more sensitive than adult patients to glucocorticoid-induced suppressive action on the hypothalamic-pituitary-adrenal axis and exogenous corticosteroid effects due to the greater ratio of skin surface area to body weight.
In children who received corticosteroids externally, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, reduced weight gain and increase in intracranial pressure (intracranial hypertension) were observed. Suppression of the hypothalamic-pituitary-adrenal axis is manifested in children by low plasma cortisol levels and lack of response to ACTH stimulation. The increase in intracranial pressure is manifested by protuberance of the fontanel, headache and bilateral papilledema.
[SmPC DIPROSONE®]

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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 in children

Children have a relatively large skin surface and thin skin. In children long-term use on large surfaces can lead to systemic side effects, adrenal suppression and also growth hormone suppression; In long-term use on large surfaces, it is recommended to regularly check height and weight and determine the plasma cortisol level.

In infants and toddlers, the diaper can act as an occlusive dressing and thus the
increase absorption

Careful consideration is needed when applied to the eyelids because of the possibility of contaminating the conjunctiva (and the risk of glaucoma simplex or subcapsular cataracts occurring) on the one hand, and the risk of corneal damage due to the continuous rubbing/scratching of untreated eczema on the other.

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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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Corticosteroids, weak (group I)
D07AA02
Corticosteroids, moderately potent (group II)
D07AB02
Corticosteroids, potent (group III)
D07AC03
D07AC17
D07AC13

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References

  1. Krakowski AC, et al, Management of Atopic Dermatitis in the Pediatric Population, Pediatrics, 2008, Vol. 122 No. 4, 812-824
  2. CBO, Richtlijn Constitutioneel Eczeem, www.cbo.nl, Maart 2015
  3. NHG, Standaard constitutioneel exceem (M37), www.nhg.nl, augustus 2006
  4. van Basten JP, et al, [The use of corticosteroid cream to treat phimosis], Ned Tijdschr Geneeskd, 2003, Aug 9;147(32), 1544-7
  5. GlaxoSmithKline BV, SPC Betnelan 20 december 2013, www.cbg-meb.nl
  6. Dirven-Meijer PC et al, NHG standaard Eczeem, Huisarts Wet, 2014, 57(5), 240-52
  7. Ghysel C, et al , Long-term efficiency of skin stretching and a topical corticoid cream application for unretractable foreskin and phimosis in prepubertal boys. , Urol Int. , 2009, 82(1), 81-8

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Changes

Changes