Proglycem Suspension

— THERAPEUTIC CATEGORIES —
  • Cytoprotective and supportive care agents

Proglycem Suspension Generic Name & Formulations

General Description

Diazoxide 50mg/mL; chocolate-mint flavor; contains alcohol 7.25%.

Pharmacological Class

Nondiuretic benzothiadiazine derivative.

How Supplied

Susp—30mL (w. dropper)

Manufacturer

Proglycem Suspension Indications

Indications

Management of hypoglycemia due to hyperinsulinism associated with: inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy in adults; leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis in infants and children.

Proglycem Suspension Dosage and Administration

Adults and Children

Individualize. Infants and newborns: Initially 10mg/kg/day divided into 3 equal doses every 8hrs. Usual range: 8–15mg/kg divided into 2–3 equal doses every 8–12hrs. Adults and children: Initially 3mg/kg/day divided into 3 equal doses every 8hrs. Usual range: 3–8mg/kg divided into 2–3 equal doses every 8–12hrs. Refractory hypoglycemia: may require higher dosages. Discontinue if not effective after 2–3 weeks.

Proglycem Suspension Contraindications

Contraindications

Functional hypoglycemia. Thiazide hypersensitivity.

Proglycem Suspension Boxed Warnings

Not Applicable

Proglycem Suspension Warnings/Precautions

Warnings/Precautions

Compromised cardiac reserve: may precipitate CHF. Hyperuricemia. History of gout. Renal impairment: consider reducing dose; evaluate serum electrolyte levels. Newborns with increased bilirubinemia. Monitor for respiratory distress (esp. in those with risk factors); discontinue if pulmonary hypertension is suspected. Monitor blood glucose, BUN, creatinine clearance, hematocrit, platelets, total and differential leukocyte counts, AST, serum uric acid periodically until stabilized. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Proglycem Suspension Pharmacokinetics

See Literature

Proglycem Suspension Interactions

Interactions

Antihypertensives potentiated. Concomitant coumarin: may need to reduce dose of anticoagulant. Concomitant diphenylhydantoin may result in loss of seizure control. Concomitant thiazides, other diuretics may potentiate hyperglycemic and hyperuricemic effects. Inhibits glucagon-stimulated insulin release and causes false-negative insulin response to glucagon.

Proglycem Suspension Adverse Reactions

Adverse Reactions

Sodium and fluid retention, diabetic ketoacidosis, hyperosmolar nonketotic coma, hirsuitism, hyperglycemia, glycosuria, GI upset, tachycardia, palpitations, increased serum uric acid, thrombocytopenia (may require discontinuation), neutropenia, rash, headache, weakness, malaise.

Proglycem Suspension Clinical Trials

See Literature

Proglycem Suspension Note

Not Applicable

Proglycem Suspension Patient Counseling

See Literature