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Uses

Severe Hypertension

Used for emergency lowering of DBP in hypertensive crises (hypertensive emergencies) in adults with severe, nonmalignant or malignant (severe accelerated) hypertension and in children with acute severe hypertension. Situations in which immediate reduction in BP is needed to prevent or limit target organ damage include hypertensive encephalopathy, intracranial hemorrhage, stroke, unstable angina pectoris, AMI, acute left ventricular failure with pulmonary edema, dissecting aortic aneurysm, head trauma, and life-threatening arterial bleeding.

Intended for short-term use in hospitalized patients only.

Other IV hypotensive agents generally are preferred unless intensive monitoring is not available.

Has been used successfully for the management of hypertensive emergencies associated with pregnancy (e.g., preeclampsia, eclampsia) when delivery is imminent, but safe use in pregnant women not clearly established and other antihypertensives (e.g., IV hydralazine) are preferred. (See Pregnancy under Cautions.)

May be of particular value in patients with malignant hypertension associated with renal impairment. Usually effective in patients who are resistant to other hypotensive agents.

Has been used IV in the management of hypertensive urgencies†, which are situations (e.g., upper levels of severe hypertension, hypertension with optic disk edema, progressive target organ complications, severe perioperative hypertension) in which it is desirable to reduce BP within a few hours. However, such urgencies usually can be managed with oral doses of drugs with a relatively rapid onset of action.

Has also been used orally† for the management of hypertension; however, its hyperglycemic and sodium-retaining effects make it unsuitable for chronic therapy.

Diazoxide is ineffective in the management of hypertension caused by pheochromocytoma.

Hypoglycemia

Adults: Used orally in the management of hypoglycemia caused by hyperinsulinism associated with inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy.

Infants and children: Used orally in the management of hypoglycemia associated with leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis.

Adults and children: May be used preoperatively as a temporary measure, and postoperatively if hypoglycemia persists.

Should be used only after diagnosis of hypoglycemia caused by one of the above conditions has been definitely established and when specific medical or surgical management has been unsuccessful or is not feasible.

Dosage and Administration

General

• Since repeated administration of diazoxide may cause sodium and water retention, administer a diuretic to patients receiving multiple doses of the drug IV or orally.

Severe Hypertension

• Adjust dosage according to the degree of hypertension and the patient’s BP response and tolerance.
• Patient should remain supine during, immediately following, and preferably for ≥1 hour after IV administration of the drug. When furosemide is administered in conjunction with IV diazoxide, patient should remain supine for 8–10 hours.
• Monitor BP closely until it has stabilized and hourly thereafter. In ambulatory patients, perform final BP measurement while the patient is standing.
• Investigate additional decreases in BP 30 minutes or more after injection for causes other than the effects of the drug.
• Use principally in hospitals or where there are adequate facilities readily available for the management of hypotension induced by the drug. Attempt to achieve desired BP reduction over as long a period of time as is compatible with the patient’s clinical status (manufacturer suggests at least several hours and preferably 1 or 2 days).
• Replace IV diazoxide treatment with oral hypotensive agents as soon as adequate control of BP is achieved; administration of diazoxide for >4–5 days seldom necessary.

Hypoglycemia

• Individualize oral dosage based on severity of condition, blood glucose concentration, and clinical response of patient.
• Observe patients closely when treatment is initiated. Monitor blood glucose concentrations until patient's condition has stabilized; usually requires several days.
• If hyperglycemia or glycosuria occurs, reduction in dosage may be required to avoid progession to ketoacidosis or hyperosmolar coma.
• Discontinue drug if not effective after 2–3 weeks. In patients who respond to diazoxide, therapy must be continued for several years. The drug may be discontinued when insulin-glucose ratios and insulin responses to provocative tests are normal.
• Adjust dosage as necessary if patients are changed from one oral dosage formulation to another (capsules, suspension).

Administration

Administer orally or by IV injection. Do not administer IM, sub-Q, or into body cavities.

IV Administration

Administer undiluted by rapid IV injection over a period of ≤30 seconds into a peripheral vein via an established IV line.

Avoid extravasation into subcutaneous tissues.

Dosage

Pediatric Patients

Severe Hypertension

IV

“Minibolus” regimen: 1–3 mg/kg (up to 150 mg per dose) or 50–100 mg total every 5–15 minutes until adequate reduction in BP (e.g., DBP <100 mm Hg) is achieved; the use of 300-mg doses is no longer recommended. Subsequent dosing intervals depend on individual patient response. Repeated administration at 4- to 24-hour intervals generally maintains BP below pretreatment levels.

Hypertensive emergencies: Initial goal is to reduce mean arterial BP by no more than 25% within minutes to 1 hour, followed by further reduction if stable toward 160/100 mm Hg within the next 2–6 hours. Avoid excessive reductions in BP. If this BP is well tolerated and the patient is clinically stable, may administer additional doses to achieve further gradual BP reductions toward normal in the next 24–48 hours.

Aortic dissection: Goal is to reduce systolic pressure to <100 mm Hg if tolerated.

Hypoglycemia

Oral

Children: Usual initial dosage is 3 mg/kg daily given in 3 equal doses every 8 hours.

Children: Usual maintenance dosage is 3–8 mg/kg daily given in 2 or 3 divided doses every 12 or 8 hours, respectively.

Refractory hypoglycemia in children: May require high doses; dosages as high as 10–15 mg/kg daily have been used.

Infants and neonates: Usual initial dosage is 10 mg/kg daily given in 3 equal doses every 8 hours.

Infants and neonates: Usual maintenance dosage is 8–15 mg/kg daily given in 2 or 3 equal doses every 12 or 8 hours, respectively.

Adults

Severe Hypertension

IV

“Minibolus” regimen: 1–3 mg/kg (up to 150 mg per dose) or 50–100 mg total every 5–15 minutes until adequate reduction in BP (e.g., DBP <100 mm Hg) is achieved; the use of 300-mg doses is no longer recommended. Subsequent dosing intervals depend on individual patient response. Repeated administration at 4- to 24-hour intervals generally maintains BP below pretreatment levels.

Hypertensive emergencies: Initial goal is to reduce mean arterial BP by no more than 25% within minutes to 1 hour, followed by further reduction if stable toward 160/100 mm Hg within the next 2–6 hours. Avoid excessive reductions in BP. If this BP is well tolerated and the patient is clinically stable, may administer additional doses to achieve further gradual BP reductions toward normal in the next 24–48 hours.

Aortic dissection: Goal is to reduce systolic pressure to <100 mm Hg if tolerated.

Severe hypertension: Has been administered by constant IV infusion† at rates ranging from 7.5–30 mg/minute in various dosing schedules. Consult specialized references for specific recommendations.

Replace IV diazoxide with oral hypotensive agent therapy as soon as adequate control of BP is achieved; administration for >4–5 days seldom necessary.

Hypoglycemia

Oral

Usual initial dosage: 3 mg/kg daily given in 3 equal doses every 8 hours (i.e., approximately 200 mg daily for an average adult).

Usual maintenance dosage: 3–8 mg/kg daily given in 2 or 3 equal doses every 12 or 8 hours, respectively.

Refractory hypoglycemia: May require high doses; dosages as high as 10–15 mg/kg daily have been used.

Prescribing Limits

Pediatric Patients

Severe Hypertension

IV

150 mg every 5–15 minutes until adequate reduction in BP is achieved.

Maximum duration of therapy: 10 days.

Adults

Severe Hypertension

IV

150 mg every 5–15 minutes until adequate reduction in BP is achieved.

Maximum duration of therapy: 10 days.

Special Populations

Dosage in Renal Impairment

Patients with Hypoglycemia

Oral

Since plasma half-life is prolonged with renal impairment, consider reduced dosage.