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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Constitutional tall height in girls
Oral
≥ 9 years
Initial dose:
Medicinal treatment is not preferred for this indication because of the long term side-effects on fertility. In individual cases it can be prescribed by a paediatric endocrinologist after careful consideration, after the parents have been informed.
50
microg./day
in 1
dose For 1 week.
Maintenance dose:
Build up after 1 week to
100
- 200
microg./day
in 1
dose. Max: 200 microg./day.
Duration of treatment:
Continue treatment until epiphyseal discs are completely closed.
The first 10-14 days of the month combined with medroxyprogesterone, 10 mg/day in a single dose.
Puberty induction in girls with Turner’s syndrome
Oral
From bone ages of
≥ 12 years
Initial dose:
0.05
microg./kg/day
in 1
dose
Maintenance dose:Slow increase PER YEAR by
0.05
microg./kg/day
in 1
dose
Puberty induction in pubertas tarda: hypogonadism
Oral
≥ 11 years
0.05
microg./kg/day
in 1
dose
Increase every 6-9 months until breakthrough bleeding occurs.
Add medroxyprogesterone in breakthrough bleeding or after 1-2 years. When the adult dosage of 20 mcg ethinylestradiol is reached, switch to a combination pill or a contraceptive pill.
Priming before a growth hormone test
Oral
≥ 8 years
50
microg./day
in 2
doses.
Duration of treatment:
3-5 days
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
The treatment for constitutionally tall women gives an increased risk of fertility disorders and unwanted childlessness. Only to be prescribed in individual cases by a paediatric or other endocrinologist, after careful consideration of the risks and after consultation with parents about the risks.
Prior to treatment, the skeletal age should be determined and an accurate adult final height prognosis should be calculated. Periodic checks (e.g. twice a year) of the epiphyseal discs by X-rays of the non-dominant hand and wrist are recommended during treatment.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Nederlandse Groeistichting en de Adviesgroep Groeihormoon van de Nederlandse Vereniging Kindergeneeskunde, Behandeling van kleine lengte bij meisjes met Turner syndroom, www.nvk.nl, mei 2005, http://www.nvk.nl/Kwaliteit/Richtlijnenenindicatoren/Richtlijnen/Turnersyndroomvan/tabid/370/language/nl-NL/Default.aspx
Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www,nvk.nl (alleen leden), 2010
Hendriks AEJ, et al, Fertility and Ovarian Function in High-Dose Estrogen- Treated Tall Women, J Clin Endocrinol Metab, 2011, Apr 96 (4), 1098-105