PROGLYCEM- diazoxide suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DIAZOXIDE (UNII: O5CB12L4FN) (DIAZOXIDE - UNII:O5CB12L4FN)

Disponibil de la:

Teva Pharmaceuticals USA, Inc.

INN (nume internaţional):

DIAZOXIDE

Compoziție:

DIAZOXIDE 50 mg in 1 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

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.