Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
DIAZOXIDE (UNII: O5CB12L4FN) (DIAZOXIDE - UNII:O5CB12L4FN)
Teva Pharmaceuticals USA, Inc.
DIAZOXIDE
DIAZOXIDE 50 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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. The use of PROGLYCEM for functional hypoglycemia is contraindicated. The drug should not be used in patients hypersensitive to diazoxide or to other thiazides unless the potential benefits outweigh the possible risks.
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® 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 Capsules and Suspension at 25°C (77°F) excursions permitted 15°-30°C (59-86°F). [See USP Controlled Room Temperature]. Rx only Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 ©2022 Teva Pharmaceuticals USA, Inc. Rev. 12/2022 PRGM-002
New Drug Application
PROGLYCEM- DIAZOXIDE SUSPENSION TEVA PHARMACEUTICALS USA, INC. ---------- PROGLYCEM BRAND OF DIAZOXIDE CAPSULES SUSPENSION, USP FOR ORAL ADMINISTRATION RX ONLY DESCRIPTION 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-2_H_-1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C H ClN O S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water. CLINICAL PHARMACOLOGY Diazoxide administered orally produces a prompt dose-related increase in blood glucose level, due primarily to an inhibition of insulin release from the pancreas, and also to an extrapancreatic effect. The hyperglycemic effect begins within an hour and generally lasts no more than eight ® ® 8 7 2 2 hours in the presence of normal renal function. PROGLYCEM decreases the excretion of sodium and water, resulting in fluid retention which may be clinically significant. The hypotensive effect of diazoxide on blood pressure is usually not marked with the oral preparation. This contrasts with the intravenous preparation of diazoxide (see ADVERSE REACTIONS). Other pharmacologic actions of PROGLYCEM include increased pulse rate; increased serum uric acid levels due to decreased excretion; increased serum levels of free fatty acids' decreased chloride excretion; decreased para-aminohippuric acid; (PAH) clearance with no appreciable effect on glomerular filtration rate. Lesen Sie das vollständige Dokument