- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The half-life in children from 4 months to 6 years varies from 9.5 to 24 hours in long-term use of the oral dose.
> 90% bound to serum proteins.
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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
| Congenital hyperinsulinism |
|---|
|
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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.
Clinical consequences
With impaired renal function, the half-life of diazoxide is prolonged. However, diazoxide is always dosed according to effect and side effects; this is no different in the case of impaired renal function.
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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
Fluid retention, hypertrichosis, pulmonary hypertension, cardiac failure and neutropenia; most symptoms disappear after stopping the therapy. Hirsutism of the lanugo type.
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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
Cataract observed in babies. This recovered after correction of the fluid balance.
Pulmonary hypertension has been reported in infants and neonates. This occurs especially in neonates with risk factors such as meconium aspiration syndrome, hyaline membrane disease, neonatal tachypnoea, pneumonia, sepsis, congenital diaphragmatic hernia and congenital heart diseases. If pulmonary hypertension occurs in a child, the treatment should be discontinued. The pulmonary hypertension is then reversible.
Caution is recommended when used in neonates with elevated bilirubin levels, as diazoxide can displace bilirubin from its protein binding (SmPC Proglicem 25/100)
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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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| Antidotes | ||
|---|---|---|
| V03AB15 | ||
| V03AB14 | ||
| Iron chelating agents | ||
|---|---|---|
| V03AC03 | ||
| V03AC02 | ||
| V03AC01 | ||
| Detoxifying agents for antineoplastic treatment | ||
|---|---|---|
| V03AF03 | ||
| V03AF01 | ||
| V03AF07 | ||
| DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT | ||
|---|---|---|
| V03AF03 | ||
| V03AF01 | ||
| V03AF07 | ||
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References
- Fafoula O, et al, Prolonged hyperinsulinaemic hypoglycaemia in newborns with intrauterine growth retardation, Arch Dis Child Fetal Neonatal Ed, 2006, Nov;91(6), F467
- Hoe FM, et al, Clinical features and insulin regulation in infants with a syndrome of prolonged neonatal hyperinsulinism, J Pediatr, 2006, Feb;148(2), 207-1
- Giurgea I, et al, [Congenital hyperinsulinism in newborn and infant] L'hyperinsulinisme congenital du nouveau-ne et du nourrisson. , Arch Pediatr., 2005, Nov;12(11), 1628-3
- Tyrrell VJ, et al, Ten years' experience of persistent hyperinsulinaemic hypoglycaemia of infancy, J Paediatr Child Health., 2001, Oct;37(5), 483-8
- Ortqvist E, et al, Temporary preservation of beta-cell function by diazoxide treatment in childhood type 1 diabetes, Diabetes Care, 2004, Sep;27(9), 2191-7
- Yildizdas D, et al, Pulmonary hypertension, heart failure and neutropenia due to diazoxide therapy, Adv Ther, 2008, May;25(5), 515-9
- Nebesio TD, et al, Development of pulmonary hypertension in an infant treated with diazoxide, J Pediatr Endocrinol Metab, 2007 , Aug;20(8), 939-44
- MSD BV, SPC Proglicem (RVG 06865), www.cbg-meb.nl, Geraadpleegd 20 april 2011, http://db.cbg-meb.nl/IB-teksten/h06865.pdf
- FDA Drug safety communications, FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide), www.fda.gov, 16-7-2015
- MSD Sharp & Dohme GmbH, SmPC PROGLICEM® 25/100 mg Hartkapseln (6426992.01.00), 10/2021
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Changes
Changes
