Proglycem
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Questions & Answers
Side Effects & Adverse Reactions
The antidiuretic property of diazoxide may lead to significant fluid retention, which in patients with compromised cardiac reserve, may precipitate congestive heart failure. The fluid retention will respond to conventional therapy with diuretics.
It should be noted that concomitantly administered 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 recommended doses of PROGLYCEM® usually during intercurrent illness. Prompt recognition and treatment are essential (See OVERDOSAGE), and prolonged surveillance following the acute episode is necessary because of the long drug half-life of approximately 30 hours. The occurrence of these serious events may be reduced by careful education of patients regarding the need for monitoring the urine for sugar and ketones and for prompt reporting of abnormal findings and unusual symptoms to the physician. Transient cataracts occurred in association with hyperosmolar coma in an infant, and subsided on correction of the hyper-osmolarity. Cataracts have been observed in several animals receiving daily doses of intravenous or oral diazoxide.
The development of abnormal facial features in four children treated chronically (>4 years) with PROGLYCEM® for hypoglycemia hyperinsulinism in the same clinic has been reported.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PROGLYCEM® (ORAL DIAZOXIDE) is useful in 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. PROGLYCEM ® may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.
PROGLYCEM® should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM® should be considered.
History
There is currently no drug history available for this drug.
Other Information
PROGLYCEM® (diazoxide) is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. PROGLYCEM® Capsules contain 50 mg diazoxide, USP. The Suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.25%. Other ingredients: Sorbitol solution, chocolate cream flavor, propylene glycol, magnesium aluminum silicate, carboxymethycellulose sodium, mint flavor, sodium benzoate, methylparaben, poloxamer 188, propylparaben, and purified water. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
Diazoxide has the following structural formula:
Diazoxide is 7-chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C8H7ClN2O2S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water.
Sources
Proglycem Manufacturers
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Teva Global Respiratory Research Llc
![Proglycem (Diazoxide) Suspension [Teva Global Respiratory Research Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Proglycem | Teva Branded Pharmaceutical Products R&d, Inc.
Patients should be under close clinical observation when treatment with PROGLYCEM® is initiated. The clinical response and blood glucose level should be carefully monitored until the patient's condition has stabilized satisfactory; in most instances, this may be accomplished in several days. If administration of PROGLYCEM® is not effective after two or three weeks, the drug should be discontinued.
The dosage of PROGLYCEM® must be individualized based on the severity of the hypoglycemic condition and the blood glucose level and clinical response of the patient. The dosage should be adjusted until the desired clinical and laboratory effects are produced with the least amount of the drug. Special care should be taken to assure accuracy of dosage in infants and young children.
Adults and children:The usual daily dosage is 3 to 8 mg/kg, divided into two or three equal doses every 8 or 12 hours. In certain instances, patients with refractory hypoglycemia may require higher dosages. Ordinarily, an appropriate starting dosage is 3 mg/kg/day, divided into three equal doses every 8 hours. Thus an average adult would receive a starting dosage of approximately 200 mg daily.
Infants and newborns:The usual daily dosage is 8 to 15 mg/kg divided into two or three equal doses every 8 to 12 hours. An appropriate starting dosage is 10 mg/kg/day, divided into three equal doses every 8 hours.
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