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Proglycem

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Proglycem

Indications
Dosage
How Supplied

INDICATIONS

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® (diazoxide capsules) may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.

PROGLYCEM® (diazoxide capsules) 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® (diazoxide capsules) should be considered.

DOSAGE AND ADMINISTRATION

Patients should be under close clinical observation when treatment with PROGLYCEM® (diazoxide capsules) 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® (diazoxide capsules) is not effective after two or three weeks, the drug should be discontinued.

The dosage of PROGLYCEM® (diazoxide capsules) 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.

HOW SUPPLIED

PROGLYCEM® (diazoxide capsules, USP), 50 mg, half opaque orange and half clear capsules, branded in black with BNP 6000: bottle of 100 (NDC 0575-6000-01).

PROGLYCEM® (diazoxide capsules) suspension, 50 mg/mL, a chocolate-mint flavored suspension; bottle of 30 ml (NDC 0575-6200-30), with dropper calibrated to deliver 10, 20, 30, 40 and 50 mg diazoxide. 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. Store PROGLYCEM® (diazoxide capsules) ® Capsules and Suspension at 25°C (77°F) excursions permitted 15°-30°C (59-86°F). [See USP Controlled Room Temperature].

PROGLYCEM® (diazoxide capsules, USP), manufactured by IVAX Pharmaceuticals, Inc., Miami, Florida 33137. PROGLYCEM® (diazoxide USP), Oral Suspension, manufactured by TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. Suspension Manufactured for: GATE PHARMACEUTICALS Div. of Teva Pharmaceuticals USA Sellersville, PA 18960. FDA Rev date: 12/17/2008

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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