DIAZOXIDE suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

e5 Pharma, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Diazoxide Oral Suspension 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. Diazoxide Oral Suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. Diazoxide 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 diazoxide should be considered. The use of diazoxide 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.

Resumen del producto:

Diazoxide Oral Suspension, USP 50 mg/mL, a chocolate-mint flavored suspension; bottle of 30 mL (NDC 13517-100-30), 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 Diazoxide Oral Suspension at 25°C (77°F) excursions permitted 15°-30°C (59-86°F). [See USP Controlled Room Temperature]. Rx only Manufactured for: e5 Pharma, LLC Boca Raton, FL 33432 1000001287  Rev. 08/2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DIAZOXIDE- DIAZOXIDE SUSPENSION
E5 PHARMA, LLC
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DIAZOXIDE ORAL SUSPENSION, USP
FOR ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
Diazoxide is a nondiuretic benzothiadiazine derivative taken orally
for the management of
symptomatic hypoglycemia. Diazoxide Oral Suspension, USP 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 mint flavor, propylene
glycol, magnesium
aluminum silicate, carboxymethycellulose sodium, 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
hours in the presence of normal renal function.
Diazoxide decreases the excretion of sodium and water, resulting in
fluid retention which
8
7
2
2
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 diazoxide 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.
The concomitant administration of a benzothiazide diuretic may
intensify the
hyperglycemic and hyperu