Diazoxide

Generic name
Diazoxide
Brand name
ATC Code
V03AH01
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.

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

Congenital hyperinsulinism
  • Oral
    • < 1 year
      [1] [2] [3] [4] [5] [6] [7]
      • Initial dose: 10 mg/kg/day in 2 doses.
      • Maintenance dose: Thereafter depending on the effect 5 - 15 mg/kg/day in 2 doses. Max: 20 mg/kg/day.

      • In combination with a diuretic (chlorothiazide, furosemide) in fluid retention.
        Only use the maximum dose in exceptional cases; administer in 3 doses

    • 1 year up to 18 years
      [1] [2] [3] [4] [5] [6] [7]
      • Initial dose: 5 mg/kg/day in 2 doses.
      • Maintenance dose: Depending on the effect 3 - 8 mg/kg/day in 2 - 3 doses.

      • In combination with a diuretic (chlorothiazide, furosemide) in fluid retention.

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.

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.

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)

 

Interactions

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

ALL OTHER THERAPEUTIC PRODUCTS

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

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

References

  1. Fafoula O, et al, Prolonged hyperinsulinaemic hypoglycaemia in newborns with intrauterine growth retardation, Arch Dis Child Fetal Neonatal Ed, 2006, Nov;91(6), F467
  2. 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
  3. 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
  4. Tyrrell VJ, et al, Ten years' experience of persistent hyperinsulinaemic hypoglycaemia of infancy, J Paediatr Child Health., 2001, Oct;37(5), 483-8
  5. 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
  6. Yildizdas D, et al, Pulmonary hypertension, heart failure and neutropenia due to diazoxide therapy, Adv Ther, 2008, May;25(5), 515-9
  7. Nebesio TD, et al, Development of pulmonary hypertension in an infant treated with diazoxide, J Pediatr Endocrinol Metab, 2007 , Aug;20(8), 939-44
  8. MSD BV, SPC Proglicem (RVG 06865), www.cbg-meb.nl, Geraadpleegd 20 april 2011, http://db.cbg-meb.nl/IB-teksten/h06865.pdf
  9. 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
  10. MSD Sharp & Dohme GmbH, SmPC PROGLICEM® 25/100 mg Hartkapseln (6426992.01.00), 10/2021

Changes

Therapeutic Drug Monitoring


Overdose