- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
A prospective PK study in 6 children aged 1.9 years to 8.3 years with micropenis found the following PK parameters after percutaneous administration of 0.15 to 0.33 mg/kg once daily [Charmandari 2001]:
| Tmax (hours) | 2-8 |
| Cmax (nmol/L) | 0.98-23.80 |
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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
| Pre-operative for hypospadias |
|---|
|
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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
The following transient side effects were seen: itching, redness, penile skin darkening [Kaya 2008][Choi 1993], suppression of the pituitary-gonadal axis, decrease of serum sex hormone binding globulin, decrease in total cholesterol, HDL and HDL-total cholesterol ratios, increase of alkaline phosphatase [Choi 1993].
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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
Parents are recommended to wear gloves when applying the gel.
Monitoring during treatment should include regular pubertal assessment and measurement of DHT and testosterone concentrations on days 3 or 4 of treatment and prior to DHT gel application to ensure that the concentrations attained are not raised to a level that would be expected to result in the systemic effects described in association with percutaneous DHT treatment [Charmandari 2001].
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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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| 3-oxoandrosten (4) derivatives | ||
|---|---|---|
| G03BA03 | ||
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References
- Besins Healthcare, Bijsluiter Andractim 2,5%
- Kaya C, et al, The efficacy of dihydrotestosterone transdermal gel before primary hypospadias surgery: a prospective, controlled, randomized study, J Urol, 2008, Feb;179(2), 684-8
- Kinderurologen ErasmusMC, Expert opinie
- Choi SK, et al., Transdermal dihydrotestosterone therapy and its effects on patients with microphallus., J Urol., 1993, 150(2), 657-60
- Charmandari E, et al., Kinetics and effect of percutaneous administration of dihydrotestosterone in children., Horm Res., 2001, 56(5-6), 177-81
- Montfort G, et al., Dehydrotestosterone penile stimulation in hypospadias surgery., Eur Urol., 1982, 8(4), 201-3
- Jackson L, et al., Long-term Effects of Pre-operative Testosterone and Dihydrotestosterone on Glans Width in Boys With Hypospadias., J Pediatr Surg., 2024, 59(10)
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Changes
Changes
