BUMETANIDE injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

BUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE - UNII:0Y2S3XUQ5H)

Предлага се от:

Hospira, Inc.

INN (Международно Name):

BUMETANIDE

Композиция:

BUMETANIDE 0.25 mg in 1 mL

Начин на приложение:

INTRAMUSCULAR

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Bumetanide injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity. Bumetanide is contraindicated in anuria. Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

Каталог на резюме:

NDC 0409-1412-04 1 mg/4 mL 10 Single-dose vials in a carton (0.25 mg/mL) NDC 0409-1412-10 2.5 mg/10 mL 10 Multi-dose vials in a carton (0.25 mg/mL)   Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. Retain in carton until ready to use. Do not use the injection if it is discolored or contains a precipitate. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0881-5.0 Revised: 3/2021

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BUMETANIDE- BUMETANIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
BUMETANIDE INJECTION, USP
R only
WARNING
Bumetanide injection is a potent diuretic which, if given in excessive
amounts, can
lead to a profound diuresis with water and electrolyte depletion.
Therefore, careful
medical supervision is required, and dose and dosage schedule have to
be adjusted
to the individual patient's needs (see DOSAGE AND ADMINISTRATION).
DESCRIPTION
Bumetanide is a loop diuretic, available in 4 mL and 10 mL vials for
intravenous or
intramuscular injection as a sterile solution. Each mL contains 0.25
mg bumetanide
compounded with 0.85% sodium chloride and 0.4% ammonium acetate as
buffers;
0.01% edetate disodium; 1% benzyl alcohol as preservative, and pH
adjusted to
approximately 7 with sodium hydroxide.
Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic
acid. It is a
practically white powder, slightly soluble in water; soluble in
alkaline solutions, having a
calculated molecular weight of 364.42, and the following structural
formula:
Molecular Formula: C
H
N O S
CLINICAL PHARMACOLOGY
Bumetanide is a loop diuretic with a rapid onset and short duration of
action.
Pharmacological and clinical studies have shown that 1 mg bumetanide
has a diuretic
potency equivalent to approximately 40 mg furosemide. The major site
of bumetanide
action is the ascending limb of the loop of Henle.
The mode of action has been determined through various clearance
studies in both
humans and experimental animals. Bumetanide inhibits sodium
reabsorption in the
ascending limb of the loop of Henle, as shown by marked reduction of
free-water
clearance (CH O) during hydration and tubular free-water reabsorption
(T H O) during
x
17
20
2
5
2
C
2
hydropenia. Reabsorption of chloride in the ascending limb is also
blocked by
bumetanide, and bumetanide is somewhat more chloruretic than
natriuretic.
Potassium excretion is also increased by bumetanide, in a dose-related
fashion.
Bumetanide may have an additional action in the proximal tubule. Since