EUDEMINE (DIAZOXIDE) 50MG 100's

EUDEMINE contains diazoxide, a non-diuretic benzothiadiazine derivative that opens ATP-sensitive potassium channels in pancreatic beta-cells, hyperpolarising the cell membrane and inhibiting insulin secretion.

This raises blood glucose levels, making it useful for the management of hypoglycaemia caused by excess insulin production.

Oral diazoxide is indicated for the management of hypoglycaemia associated with:

·       congenital hyperinsulinism (persistent hyperinsulinaemic hypoglycaemia of infancy - PHHI) in neonates and children

·       insulinoma (benign insulin-secreting pancreatic tumour) where surgery is not possible or contraindicated;

·       islet cell hyperplasia; and extrapancreatic tumours causing hypoglycaemia (e.g., some sarcomas secreting IGF-2).

Note: Intravenous diazoxide (Eudemine IV) is a separate preparation used for hypertensive emergencies. The oral preparation discussed here is used exclusively for hypoglycaemia management and has no role in hypertension treatment.

The dose of oral diazoxide is highly individualised based on response (blood glucose monitoring). It is adjusted to maintain blood glucose in the normal range.

Adults and Children Over 3 Years

•       Starting dose: 3 - 5 mg/kg/day in two or three divided doses.

•       Usual maintenance range: 3–8 mg/kg/day in two or three divided doses.

•       Maximum dose: 15 mg/kg/day (rarely needed).

Neonates and Infants

•       Starting dose: 5–10 mg/kg/day in two or three divided doses.

•       Adjust based on blood glucose monitoring — target fasting glucose above 3.5 mmol/L.

Diazoxide is best given with food to reduce gastrointestinal side effects. Co-administration with a thiazide diuretic (e.g., chlorothiazide 7–10 mg/kg/day) can enhance the hyperglycaemic effect and counteract fluid retention, particularly in neonates.

Very Common Side Effects

•       Hypertrichosis (excessive hair growth) — occurs in up to 70% of patients on long-term therapy, especially children. Fine lanugo-like hair grows on the forehead, limbs, and back. Reversible on stopping treatment.

•       Fluid retention and oedema — due to renal sodium retention. Can cause weight gain and cardiac failure in susceptible patients.

Common Side Effects

•       Hyperglycaemia — excessive blood glucose elevation if the dose is too high; monitor carefully.

•       Hyperuricaemia — elevated uric acid; may precipitate gout.

•       Nausea, vomiting, anorexia.

•       Tachycardia and palpitations.

Serious Side Effects

•       Pulmonary hypertension in neonates — reported; early discontinuation if suspected.

•       Ketoacidosis — particularly if the patient is inadequately monitored and blood glucose overshoots.

•       Blood dyscrasias (thrombocytopenia, neutropenia) — rare; monitor FBC.

•       Heart failure due to fluid retention — more common in patients with pre-existing cardiac or renal disease.

Fluid Retention Management

Diazoxide causes significant renal sodium and water retention. Neonates and infants are particularly susceptible to fluid overload. Co-prescription of a thiazide diuretic (chlorothiazide in infants, hydrochlorothiazide in older patients) both reduces fluid retention and enhances the hyperglycaemic effect of diazoxide, allowing lower doses.

Blood Glucose Monitoring

Careful glucose monitoring is essential, especially during dose titration. Aim for fasting blood glucose above 3.5 mmol/L and below 11 mmol/L. Home blood glucose monitoring should be established for patients receiving long-term therapy. Warn patients/carers about signs of both hypoglycaemia (if undertreated) and hyperglycaemia (if overtreated).

Pulmonary Hypertension — Neonates

Pulmonary hypertension has been reported in neonates receiving diazoxide. Perform echocardiography before starting treatment in neonates and consider monitoring echocardiography after initiation. If pulmonary hypertension develops, discontinue immediately.

Hypertrichosis Counselling

Warn patients and parents about hypertrichosis before starting. It is cosmetically distressing, particularly in female patients and young children. Hair growth typically begins within weeks and reverses after stopping the drug. It does not cause permanent hair growth.

•       Thiazide diuretics — intentionally combined to enhance diazoxide's hyperglycaemic effect and reduce fluid retention.

•       Phenytoin — mutual interaction; phenytoin may reduce diazoxide efficacy; diazoxide may reduce phenytoin levels.

•       Warfarin — diazoxide displaces warfarin from plasma proteins, transiently increasing free warfarin levels; monitor INR closely.

•       Sulphonylureas (glibenclamide, glipizide) — antagonise diazoxide's effect; do not combine.

•       Antihypertensives — diazoxide may enhance hypotensive effects; monitor blood pressure.

•       Store below 25 degrees Celsius, protected from light and moisture.

•       Keep in original packaging.

•       Keep out of reach of children.

•       Do not use after the expiry date.

EUDEMINE oral is a prescription-only specialist medicine (POM) in Kenya, prescribed by paediatric endocrinologists, metabolic disease specialists, and neonatologists for hyperinsulinism conditions.

It is a niche specialist drug managed within tertiary paediatric and neonatology services.

Congenital Hyperinsulinism Management

Diazoxide is the first-line pharmacological treatment for focal and diffuse congenital hyperinsulinism (CHI). Approximately 50% of diffuse CHI patients respond to diazoxide; focal CHI may respond initially but typically requires curative surgical resection. If diazoxide fails after adequate dose titration (up to 15 mg/kg/day) over 5–7 days, consider octreotide, glucagon, or surgical pancreatectomy referral.

Monitoring Schedule

•       Blood glucose: before each feed initially; then 4-hourly during inpatient titration.

•       Echocardiography: before initiating in neonates; repeat at 2 weeks.

•       FBC, renal function, electrolytes, uric acid: baseline and 2-weekly initially.

•       Weight: daily in infants; weekly during outpatient management.

Insulinoma — Palliative Use

For unresectable insulinoma, diazoxide provides effective palliation of hypoglycaemia. Doses up to 600 mg/day may be used in adults. Titrate against blood glucose. Longer-acting somatostatin analogues (octreotide LAR, lanreotide) are an alternative or adjunct.

Why does diazoxide cause hair growth?

Diazoxide opens potassium channels not only in pancreatic beta-cells but also in hair follicle cells. This stimulates the growth phase (anagen phase) of the hair follicle, resulting in increased fine hair growth (hypertrichosis), particularly on the forehead, back, and limbs. This effect typically begins within weeks of starting treatment and reverses fully once the medicine is stopped.

My baby is on diazoxide for a blood sugar condition — is this safe long-term?

Diazoxide has been used for decades in infants with persistent low blood sugar (hyperinsulinism) and is well-studied in this population. Long-term use is generally well-tolerated. Key concerns to monitor are fluid retention (managed with a diuretic), hair growth (cosmetic, reversible), and blood glucose levels. Your specialist will arrange regular monitoring to ensure your baby's safety.

What should I do if my child's blood sugar goes too high on this medicine?

If blood sugar rises above the target range (usually above 11 mmol/L) consistently, the dose may be too high. Do not adjust the dose yourself. Contact your specialist promptly to arrange a dose review. In the short term, ensure your child stays hydrated. If the glucose is very high (above 20 mmol/L) or your child is unwell, seek emergency medical advice.