Diazoxide
Generic Name: diazoxide
Brand Names:
Diazoxide
DESCRIPTION Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. Diazoxide oral suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.29%.
Overview
DESCRIPTION Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. Diazoxide oral suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.29%.
Uses
INDICATIONS & USAGE Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide oral suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. Diazoxide oral suspension should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established.
Dosage
DOSAGE & ADMINISTRATION Patients should be under close clinical observation when treatment with diazoxide oral suspension is initiated. Carefully monitor the clinical response and blood glucose until the patient’s condition has stabilized satisfactory; in most instances, this may be accomplished in several days. If administration of diazoxide oral suspension is not effective after 2 or 3 weeks, discontinue diazoxide oral suspension. Individualize the dosage of diazoxide oral suspension based on the severity of the hypoglycemic condition and the blood glucose level and clinical response of the patient. Adjust the dosage until the desired clinical and laboratory effects are produced with the least amount of diazoxide oral suspension.
Side Effects
ADVERSE REACTIONS Frequent and Serious : Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve. (see DRUG INTERACTIONS ). Infrequent but Serious : Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly. Monitor patients for up to 7 days due to the long half-life of diazoxide (see OVERDOSAGE ). Other frequent adverse reactions : Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of diazoxide oral suspension.
Interactions
DRUG INTERACTIONS Since diazoxide is highly bound to serum proteins, it may displace other substances which are also bound to protein, such as bilirubin or coumarin and its derivatives, resulting in higher blood levels of these substances. Concomitant administration of diazoxide oral suspension and diphenylhydantoin may result in a loss of seizure control. Consider these potential interactions when administering diazoxide oral suspension. The concomitant administration of thiazides or other diuretics may potentiate the hyperglycemic and hyperuricemic effects of diazoxide.
Warnings
WARNINGS The antidiuretic property of diazoxide may lead to significant fluid retention. In patients with compromised cardiac reserve, fluid retention may precipitate congestive heart failure. If fluid retention develops, manage according to standards of care. Co-administration of diazoxide oral suspension with thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide (see DRUG INTERACTIONS and ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ). Ketoacidosis and nonketotic hyperosmolar coma have been reported in patients treated with diazoxide oral suspension, usually during intercurrent illness. CONTRAINDICATIONS Diazoxide oral suspension is contraindicated in patients with: Functional hypoglycemia Hypersensitivity to diazoxide, any of the excipients in diazoxide oral suspension, or other thiazides
Storage
HOW SUPPLIED Diazoxide Oral Suspension, USP 50 mg/mL, a white to light brown colored, chocolate-mint flavored suspension; bottle of 30 mL (NDC 0254-1010-19), with dropper calibrated to deliver 10, 20, 30, 40 and 50 mg diazoxide, USP. Shake well before each use. Protect from light. Store in carton until contents are used. Store in light resistant container as defined in the USP.
Frequently Asked Questions
What is Diazoxide used for?▼
INDICATIONS & USAGE Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide oral suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. Diazoxide oral suspension should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established.
What are the side effects of Diazoxide?▼
ADVERSE REACTIONS Frequent and Serious : Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve. (see DRUG INTERACTIONS ). Infrequent but Serious : Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly. Monitor patients for up to 7 days due to the long half-life of diazoxide (see OVERDOSAGE ). Other frequent adverse reactions : Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of diazoxide oral suspension.
What are the important warnings for Diazoxide?▼
WARNINGS The antidiuretic property of diazoxide may lead to significant fluid retention. In patients with compromised cardiac reserve, fluid retention may precipitate congestive heart failure. If fluid retention develops, manage according to standards of care. Co-administration of diazoxide oral suspension with thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide (see DRUG INTERACTIONS and ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ). Ketoacidosis and nonketotic hyperosmolar coma have been reported in patients treated with diazoxide oral suspension, usually during intercurrent illness. CONTRAINDICATIONS Diazoxide oral suspension is contraindicated in patients with: Functional hypoglycemia Hypersensitivity to diazoxide, any of the excipients in diazoxide oral suspension, or other thiazides
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.