DIAZOXIDE suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Par Pharmaceutical, Inc

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 oral suspension 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 oral suspension should be considered. The use of diazoxide oral suspension 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

Descriptif du produit:

Diazoxide Oral Suspension, USP 50 mg/mL, a white to light brown colored, chocolate-mint flavored suspension; bottle of 30 mL (NDC 0254-1010-19), with dropper calibrated to deliver 10, 20, 30, 40 and 50 mg diazoxide, USP. 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, USP at 25°C (77°F), excursions permitted to 15°-30°C (59-86°F). [See USP Controlled Room Temperature]. Rx only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 09/2023 OS1010-01-16-04

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DIAZOXIDE- DIAZOXIDE SUSPENSION
PAR PHARMACEUTICAL, INC
----------
DIAZOXIDE ORAL SUSPENSION, USP
FOR ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine
derivative taken orally
for the management of symptomatic hypoglycemia. The suspension
contains 50 mg of
diazoxide, USP in each milliliter and has a chocolate-mint flavor;
alcohol content is
approximately 7.29%. Other ingredients: Sorbitol solution, chocolate
mint type flavor,
propylene glycol, magnesium aluminum silicate, carboxymethycellulose
sodium, sodium
benzoate, methylparaben, poloxamer 188, propylparaben, FD&C Red No.
40, FD&C
Yellow No. 6 and purified water. Hydrochloric acid 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 CIN 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
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’
8
7
2
2
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
inte